Dextromethorphan

The Shenzhen Public Security Bureau reproduces the 2025 catalogue and states that it was current as of 1 July 2026. The classification concerns only the catalogue.

The current Narkotikaforskriften (last amended effective 1 June 2026) expressly covers psychoactive stereoisomers of substances listed in Narkotikalisten, and the current table lists Levometorfan (N I) and Racemetorfan (metorfan) (N I), not dextromethorphan by exact name. Dextromethorphan is covered only if established to be the psychoactive dextrorotatory stereoisomer of levomethorphan, not as an analogue or generic analogue. If that condition is met, Legemiddelloven § 24 prohibits possession/use without lawful access and § 31 sets the stated up-to-six-month penalty; lawful-access and other statutory exceptions remain outside the blanket description.

The current Korean schedule identifies the substance; product formulation and authorized medical handling may be subject to additional rules.

Current LVFS 2011:10 expressly lists Dextrometorfan (DXM) in Swedish list V. Its exact exception is limited to preparations for medical or scientific use in solution containing no more than 3 mg/ml; this is a formulation/concentration exception from this narcotics-list entry, not a blanket OTC determination for all DXM. Outside the exception, the Narcotic Drugs Control Act limits importing, exporting, manufacturing, offering for sale, transferring and possessing narcotics to specified authorized purposes and persons, and the Narcotic Drugs Penal Law criminalizes unauthorized possession, use and other handling (basic maximum three years). Dexfarm 20 mg tablet is a current official product example marked prescription-only (Receptbelagt), demonstrating that medicine status is product/package-specific. Current HSLF-FS 2026:26 was published 2026-07-02 and entered into force 2026-07-14; the current consolidated LVFS expressly incorporates it. Dexfarm's prescription classification does not apply to every DXM product.

BPOM Regulation No. 12 of 2025 is the current instrument.

The Iranian FDA states that products containing dextromethorphan are under special oversight for distribution, supply and consumption. The notice does not state a universal prescription-only rule, an OTC rule, or a controlled-substance schedule for every DXM product.

The current Malaysian Ministry of Health schedule expressly lists dextromethorphan and its salts, and the Poisons Act limits Part I retail and supply to specified regulated channels. Section 19 limits professional supply or administration of a non-Group-A poison to medical, dental, or animal treatment. The applicable legal provisions do not state a standalone blanket offence phrased as recreational use of dextromethorphan being prohibited. The schedule does not establish a specific group designation or prescription classification.

The official Roszdravnadzor consolidated Resolution 681 page/PDF, redacted 11 June 2025, expressly places Декстрометорфан in List III. List III means restricted circulation with possible exclusion of some controls, and 3-FZ Article 2(5) provides the statutory small-quantity-preparation route. The schedule's notes address trade names, synonyms, preparations and derivatives; 3-FZ separately supplies the analogue and NPS rules. The product-level registration and prescription/OTC status of each dextromethorphan-containing medicine is determined by the current state medicines register and approved instruction for the exact strength/formulation. The official Roszdravnadzor archive labels its Resolution 964 index an archive as of 30 December 2020, and an official 10 April 2023 Resolution 581 page/PDF confirms a later amendment to Resolution 964; neither source alters the List III classification of dextromethorphan.

The current product record directly places Dexofan 30 mg dextromethorphan tablets in dispensing group A, and the current prescription regulation defines group A as a prescription dispensing group with the stated one-time dispensing rule. Dextromethorphan is separately named List C no. 3 in the operative 2026 euphoriants regulation, but List C's explanatory text and § 1(3)(3) exclude ordinary dosed pharmaceutical preparations containing no more than 0.1 g per unit. Dexofan contains 30 mg (0.03 g) per tablet, below that threshold; therefore the product is prescription-only rather than prohibited. The 2026 regulation sets its effective date and repeals the prior 2021 instrument.

The Egyptian Drug Authority's substance-specific decision dates from 2021.

Dextromethorphan requires a prescription.

Dextromethorphan is available through a pharmacist or by prescription.

Under an official Swissmedic list dated 14 October 2018, the intended category applies from 1 January 2019.

At product level, the official Antalya provincial Ministry of Health list places METORFAN 20 DRAJE alongside the active ingredient DEKSTROMETORFAN HBR under the heading for medicines that must be supplied by normal prescription and are subject to monitoring. The listed products include combination products (for example BENICAL, BRONKAR-A, DORFAN and GUDEF), and the prescription classification does not necessarily apply to every dextromethorphan strength, formulation, pack or combination. TİTCK Generalge 2018/1 explains that monitored normal-prescription medicines are prescribed through the Renkli Reçete Sistemi and dispensed after pharmacy recording; this does not convert them into red- or green-prescription medicines. The aggravated derivative classes specified in Law No. 7445 Article 17 do not name dextromethorphan; this omission does not establish that DXM is unscheduled.

Dextromethorphan is treated under Schedule 2 or Schedule 4 depending on formulation and quantity; not all preparations are available over the counter.

Approval is limited to the named formulation and does not extend to every dextromethorphan preparation.

The AFMPS legislation page identifies the 6 September 2017 Royal Decree as the governing framework and states that the consolidated annex aids are not themselves legally authoritative; the current Annex I aid, updated for the 29 March 2026 position and corrected 16 July 2026, expressly excludes Dextromethorphan and Dextrorphan from the surrounding generic morphinan/morphine entry. Annexes II, III, IV (including its named Annex IVB list and generic groups) and V contain no Dextromethorphan entry or matching morphinan generic group. Dextromethorphan Winadol, approved 04/2026, is Délivrance libre, but its leaflet limits use to over-12s and warns about abuse/dependence. The Medicines Act generic definition and 2006 classification decree confirm that generic identity and prescription category are distinct, and that packaging-specific derogations are permitted. AFMPS product leaflets state that Bronchosedal and Toularynx small packs are also free supply but limit use to age 6 and over; Dextroforme bulk supply is prescription-only from 360 ml and is not delivered as such to the public. These dispensing categories do not imply that every possible dextromethorphan preparation has the same dispensing category.

The June 2026 INVIMA OTC list designates the exact dextromethorphan hydrobromide concentrations, forms and combinations it enumerates as venta libre. Resolution 1403 defines OTC supply as acquisition without prescriber intervention. Resolution 0116, effective from 27 January 2026, does not expressly name dextromethorphan/dextromethorphan hydrobromide in Annex Technical 1 or human Annex Technical 3, and the similarly named D entries are distinct substances. Only enumerated dextromethorphan products are OTC, and a product containing another controlled active ingredient is not exempt. A qualifying product must match the INVIMA-listed formulation and hold the required sanitary registration; unregistered or otherwise non-compliant manufacture and marketing remain subject to sanitary measures and administrative sanctions under Decreto 677. Article 376 criminal penalties concern the scheduled substances within its text and do not make ordinary listed OTC dextromethorphan supply narcotics trafficking.

SÚKL's dextromethorphan-specific notice identifies Stopex 30 mg tablets and MedDex Vicks honey lozenges as changed from non-prescription to prescription-only effective 15 August 2017. SÚKL's 2021 professional guidance describes the broader formulation distinction (monocomponent solid forms prescription-only; monocomponent liquid and polycomponent medicines without prescription). However, the current SÚKL FAQ makes clear that dispensing information is product-level in the current medicines database, so the 2021 formulation distinction does not determine the status of every presentation. Exact current status depends on product, strength, route and pack. The current e-Sbírka schedule expressly exempts stereoisomeric dextromethorphan from the levomethorphan narcotic entry; this does not make every preparation unrestricted, because the medicines regime still applies.

Dekstrometorfaan is available for medicinal use in Estonia, but its current prescription category and any significant restrictions are not established.

Fimea's product information establishes an authorised pharmacy medicine containing DXM. It does not state the general Finnish OTC/pharmacy-only category or age restriction.

The registered product is available only from pharmacies without a prescription.

An OTC dextromethorphan syrup presentation is listed in the official database.

The Israeli Ministry of Health drug registration procedure includes an OTC combination example, but does not establish OTC status for every DXM-only product.

The current PMDA insert lists an OTC Class 2 product containing DXM.

The current schedule and amendments contain no exact dextromethorphan/dekstrometorfāns entry, although the annex lists the distinct substances levometorfāns and racemetorfāns and the controlled-substances law contains generic derivative/isomer language. The statute's broad scope clause may require interpretation for a stereoisomer-related substance. Current ZVA records list lawful medicines with both OTC and prescription classifications. Classification is product-, dose-, form- and package-dependent under Cabinet Regulation No. 885. The prescription regulation expires on 2026-09-01, so the prescription framework applies only through 2026-08-31.

The current LGS is marked text vigente with reforms through 15 January 2026. Dextrometorfano, dextromethorphan and bromhidrato de dextrometorfano do not appear by exact name, but Article 234 expressly lists levometorfan and racemetorfan and covers listed-estupefaciente isomers unless excepted. Articles 246 and 255 also preserve determination-based controls for otherwise unlisted substances or medicines. COFEPRIS's official alopathic-registration PDF, updated 4 August 2026, marks SALNADRIL (007M2026) and DEFENEXTRIL (028M2026) as Article 226 VI with future validity dates; these identified current presentations do not require a prescription or sale exclusively through pharmacies. Article 226 VI applies only to the identified products and does not establish the status of every dextromethorphan strength, combination, importer, future registration or non-medicinal material. It does not determine the law governing recreational use, possession, analogues or other formulations.

The product is dispensed only through pharmacies.

The DDB list expressly says that dextromethorphan and dextrorphan are not under international control. It separately reproduces the Philippine Schedule, which contains no exact dextromethorphan row. The related entries levomethorphan, racemethorphan and racemorphan do not cover dextromethorphan: the DDB preamble extends isomer/ester/ether/salt coverage to drugs listed in that schedule, not to an unlisted neighboring substance. The FDA Annex A entry is active-ingredient level: it gives Dextromethorphan the PH classification but does not separately enumerate hydrobromide/free-base salts, combinations, strengths, dosage forms, routes or pack sizes. Dextromethorphan therefore has a pharmacist-only non-prescription classification at the active-ingredient level, subject to product-specific registration and formulation conditions. The DDB PDF is dated July 2025.

The current GIF notice provides OTC status and per-transaction controls for DXM-containing medicines.

The current official registry lists a DXM product.

S 681/2023 deleted Dextromethorphan from Part 1 of the HPA Second Schedule and inserted it in Part 3; the current HPA schedule identifies Part 3 as active ingredients in pharmacy-only medicines. HSA defines POM as supply only by a doctor or pharmacist according to a doctor's prescription, but defines P as supply by or under pharmacist supervision. The current NDF identifies both DURO-TUSS DM DRY COUGH LIQUID 15MG/5ML (SIN17494P) and NOSPAN TABLET 30 MG (SIN10341P), each containing dextromethorphan, as PHARMACY ONLY MEDICINES. The Poisons Rules entry and 1.5% exception concern non-therapeutic products and legacy scope; HPA therapeutic products are not Class A prescription medicines.

The official consolidated schedules place the exact entry ‘Dextromethorphan.’ in Schedule 2, with no parenthetical dosage, strength, route, or formulation exception printed on that line. The Schedule 2 preamble extends this listing to preparations and mixtures containing or purporting to contain it, including salts and esters where their existence is possible, unless expressly excluded; the schedule does not determine product-specific registration, formulation, strength, route, indication, pack size, or licensing conditions. Section 22A(5)(a) limits non-prescription Schedule 2 sale to a pharmacist, pharmacist intern, or supervised pharmacist’s assistant, and section 22A(6)(a) requires prescribed sale particulars to be recorded in a prescription book or other permanent record; section 22A(6)(e) requires prescription/order safeguards for supply to a person apparently under 12. SAHPRA’s current portal records a consolidated-schedules version updated 06 July 2026, and the official Government Gazette 54627 attachment is dated 08 May 2026. SAHPRA labels the 01 August 2025 consolidation archived and ‘DO NOT USE’. The 2026 schedule entries are not necessarily unchanged. Dextromethorphan is legally regulated at the substance and Schedule 2 level, while retail availability varies by product.

Dextromethorphan is subject to Thailand's dangerous-drug and controlled-dispensing classification, not a blanket narcotics prohibition for every formulation.

The current eCFR Part 1308 text contains no dextromethorphan or dextromethorphan hydrobromide entry; its Schedule IV section identifies the separate tramadol chemical entry. DailyMed labels a dextromethorphan hydrobromide product HUMAN OTC DRUG LABEL with DEA Schedule: None and OTC Monograph Drug M012. The FDA monograph provides nonprescription status only for qualifying antitussive formulations meeting its ingredient, dosage-form, dosage, labeling, and other requirements; not every DXM formulation or product is OTC. The federal analogue statutes are fact-specific: DXM has no separate analogue determination, and its non-scheduled status does not determine whether an unrelated or novel substance is covered by 21 U.S.C. §§ 802(32) and 813.

Dextromethorphan is excluded from the listed-substance isomer control; this does not establish unrestricted OTC sale or absence from every other regulatory regime.

Dextromethorphan is excluded from CDSA Schedule I.

The current official prescription list does not name the exact INN. This omission does not determine pharmacy-only sale or classification under BtM law.

The operative 2007 decree expressly excludes Destrometorfano from Table I. Current AIFA determinations for two dextromethorphan-hydrobromide medicines classify the cited packages as SOP, not OTC (both are non-prescription). The provisional entry for procedure N1B/2024/1065 in the AIFA November 2024 CSE advisory is not the final product classification; the subsequent published AIFA determination for Bechilar gives the operative SOP classification. Unscheduled describes the ingredient's narcotic/psychotropic table status; it does not mean that every formulation is unregulated or has identical pharmacy supply conditions.

Lei n.º 19-F/2026 republished Table I-A and entered into force on 2026-05-09. Table I-A contains both the structural notes and the express dextromethorphan/dextrorphan exclusion. The structural notes generally include chemically specifically designable isomers unless expressly excluded, esters and ethers unless in another table, and possible salts including salts of those esters, ethers and isomers. The named dextromethorphan exclusion does not establish a blanket exclusion for every derivative, salt, strength, dosage form or preparation. Article 15 of Decree-Law 15/93 imposes special prescription for Tables I-II and ordinary-law prescription for Tables III-IV; those table controls do not attach merely because the expressly excluded dextromethorphan name appears. Under Estatuto do Medicamento, authorization classifies each medicine as MSRM or MNSRM; MSRM criteria and special-prescription criteria remain applicable to the exact authorized product. The official INFARMED list of medicines not subject to prescription and not reimbursed by the SNS listed 29 matching dextrometorfano entries on 2026-08-27, including oral solutions, syrups and a soft lozenge at different strengths and pack sizes. MNSRM classification applies to the listed presentations, not across the board to unlisted products.

Specifically exempted from control under the Misuse of Drugs Act 1971 and 2001.¹⁴⁷ Restricted to pharmacy sales at the discretion of the pharmacist. Purchasers typically must be at least 16 years of age. Multiple purchases may be refused or questioned.