Brand check
Is Benadryl banned in India?
Last checked 19 September 2026. A few details are still being checked against the original document.
Benadryl cough syrup is not banned in India as of 19 Sep 2026; no Section 26A notification covers its diphenhydramine or dextromethorphan formulations, and the October 2025 advisory restricts age, not the brand.
- Classification
- No ban or recall found in official records
- Decided by
- CDSCO / Ministry of Health and Family Welfare
- Reference
- No Section 26A notification; DGHS advisory 4 Oct 2025 on cough syrups for children under 2
- Latest action
- 8 October 2025
- Last checked
- 19 September 2026details being verified
Benadryl branded product (itch-stopping gel), FDA photograph. Photo: Benadryl Itch Stopping Gel (4600729217).jpg by The U.S. Food and Drug Administration (Public domain). Brand names and logos belong to their owners and are used here to identify the product this entry is about. All photo credits.
CDSCO: List of prohibited FDC drugs, 156 FDCs dated 02.08.2024
Scope. A record here does not by itself mean a product or company is unsafe or banned today. Regulatory actions can apply to one batch, one formulation, one period or one state. Always check the linked government document for the current position, and tell us if something is out of date. How we label records.
Below: Blacklisted's explanationWe organise and explain what the document says. The document above is the authority.
Key facts
- Governing authority
- CDSCO, Ministry of Health and Family Welfare
- Ban notification
- None
- Formulations
- Benadryl (diphenhydramine + ammonium chloride + sodium citrate); Benadryl DR (dextromethorphan)., being verified
- Marketer
- Kenvue (formerly Johnson & Johnson Consumer)
- Children
- DGHS advisory 4 Oct 2025: not under 2 years; avoid under 5 unless necessary
Where the claim comes from
'Is Benadryl banned in India' rose sharply in October 2025 during the cough-syrup deaths, when several brands were named in state advisories and the PIB had to deny a dextromethorphan ban. Benadryl DR contains dextromethorphan, and the base syrup contains ammonium chloride and sodium citrate, ingredients that appear in some banned multi-drug FDCs, which adds to the confusion.
Benadryl is a cough-syrup brand rather than a single medicine. The original Benadryl cough formula combines diphenhydramine, an antihistamine, with ammonium chloride and sodium citrate, which are expectorants. Benadryl DR is a dextromethorphan syrup for dry cough. Neither is banned in India.
The question became common in October 2025. When children died in Madhya Pradesh from a diethylene-glycol-contaminated syrup, states issued advisories, the Directorate General of Health Services told doctors not to prescribe cough syrups to children under two, and a rumour spread that dextromethorphan syrups had been banned. The PIB Fact Check unit denied that on 8 October 2025. None of the syrups implicated in the deaths were Benadryl products.
Some confusion also comes from the ingredient lists of banned combinations. The August 2024 FDC ban included a five-drug syrup of dextromethorphan, chlorpheniramine, ammonium chloride, sodium citrate and menthol, and the June 2023 list included other ammonium-chloride syrups. Benadryl's formulations are different products with their own licences and are not named in either order. Because manufacturers do change formulas, the current labels are flagged for verification.
For adults, Benadryl can be used as labelled; diphenhydramine causes drowsiness. For children, the October 2025 advisory is the guide, and a doctor should decide.
What this means for you
Adults can use it as labelled
Both Benadryl and Benadryl DR remain licensed.
Not for very young children
Follow the October 2025 advisory: no cough syrup under two years, and only on a doctor's advice under five.
Diphenhydramine causes drowsiness
Avoid driving after a dose; this is a label caution, not a regulatory action.
This is a record of official orders, not medical advice. Do not stop a prescribed medicine without asking your doctor or pharmacist.
Batches flagged in CDSCO alerts
Products whose name matches this brand or molecule in CDSCO monthly NSQ alerts. A flagged batch is a single batch; the company's response, where reported, is noted on the page above.
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Paracetamol, Phenylephrine Hydrochloride Diphenhydramine, Hydrocloride & Caffeine Tablets | YLT25023Mfg 2025-06 · Exp 2027-05 | YL PharmaHimachal Pradesh | The sample does not conform to the claim with respect to in Assay of Phenylephrine Hydrochloride & Caffeine (Anhydrous) (NIL).Assay | DTL JaipurState lab | Feb 2026 |
| Diphenhydramine Hydrochloride, Ammonium Chloride, Sodium Citrate and Terpin Hydrate Syrup | B46826001Mfg 2026-01 · Exp 2027-12 | Torque Phamrmaceuticals Pvt. Ltd.13B-14 | The sample does not conform to claim as per Patent and Proprietary in respect to the Assay of Sodium Citrate.Assay | RDTL, ChandigarhCDSCO lab | Feb 2026 |
| Diphenhydramine Hydrochloride, Ammonium Chloride, Sodium Citrate & Menthol Syrup | S285011Mfg 2025-04 · Exp 2027-03 | Goa Antibiotics & Pharmaceuticals Ltd. Village AnjiGoa | The sample does not conform to claim as per Patent and Proprietary in respect to the Assay of Sodium Citrate.Assay | RDTL, ChandigarhCDSCO lab | Feb 2026 |
| Diphenhydramine Hydrochloride, Ammonium Chloride, Sodium Citrate & Menthol Syrup | 2519031L002Mfg 2025-12 · Exp 2027-11 | Scott - Edil Pharmacia Ltd. Unit-IIHimachal Pradesh | The sample does not conform to claim as per Patent and Proprietary in respect to the Assay of Sodium Citrate.Assay | RDTL, ChandigarhCDSCO lab | Feb 2026 |
| Diphenhydramine HCl, Ammonium Chloride, Sodium Citrate & Menthol Syrup | ZRSL - 1806Mfg 2025-09 · Exp 2027-08 | ZRS Pharmaceuticals India Pvt. LtdHimachal Pradesh | The sample does not conform to claim as per Patent and Proprietary in respect to the Assay of Sodium Citrate and Menthol.Assay | RDTL, ChandigarhCDSCO lab | Jan 2026 |
| Paracetamol, Phenylephrine Hcl, Caffeine & Diphenhydramine Hcl Tablets | YLT25006Mfg 2025-01 · Exp 2026-12 | YL PharmaHimachal Pradesh | Identification & AssayAssay | DTL ,Baddi, HPState lab | Sep 2025 |
| Diphenhydramine Hydrochloride Capsules IP 25 mg | C 364Mfg 2024-02 · Exp 2026-01 | Bittu Pharmaceuticals (II)Maharashtra | DissolutionDissolution | State Lab KarnatakaState lab | Jun 2025 |
| Diphenhydramine Hydrochloride, Ammonium Chloride, Sodium Citrate & Menthol Syrup (Beedryl Plus) | 40183Mfg 2024-02 · Exp 2026-01 | Zenith Drugs Limited 72/5 & 72/3Madhya Pradesh | Assay of Menthol and DescriptionAssay | CDL KolkataCDSCO lab | Dec 2024 |
| Diphenhydramine Hydrochloride, Ammonium Chloride, Sodium Citrate & Menthol Syrup (Beedryl Plus) | 40186Mfg 2024-02 · Exp 2026-01 | Zenith Drugs Limited 72/5 & 72/3Madhya Pradesh | Assay of Menthol and DescriptionAssay | CDL KolkataCDSCO lab | Dec 2024 |
| Diphenhydramine Hydrochloride Capsules IP (XL Dryl-D Capsules) | CPD240100 6Mfg 2024-01 · Exp 2025-12 | Caspian PharmaceuticalsHimachal Pradesh | Dissolution and Assay of Diphenhydramin e HydrochlorideAssay | RDTL ChandigarhCDSCO lab | Apr 2024 |
| Diphenhydramine Hydrochloride, Ammonium Chloride, Sodium Citrate & Menthol Syrup | ML220730Mfg 2022-12 · Exp 2024-11 | Mascot Health Series Private LimitedUttarakhand | Assay/content of MentholAssay | CDL KolkataCDSCO lab | Nov 2023 |
| Paracetamol, Phenylphrine Hydrochloride, Diphenhydramine Hydrochloride and Caffeine Tablets (Syscold Tablets) | SPT?192Mfg 2022-01 · Exp 2023-12 | Signoret Pharmaceuticals Pvt. LtdPunjab | Disintegration test and Assay of Phenylephrine HydrochlorideAssay | RDTL ChandigarhState lab | May 2023 |
| Diphenhydramine HCl, Ammonium- Chloride and Sodium Citrate Cough Expectorant | LDS2005ALMfg 2022-12 · Exp 2024-05 | Hindustan Laboratories LtdMaharashtra | Assay of MentholAssay | RDTL ChandigarhCDSCO lab | Mar 2023 |
| PCD COLD� (Paracetamol, Phenylephrine HCl, Caffeine & Diphenhydramine HCl Tablets) | GLT-21213Mfg 2021-03 · Exp 2024-02 | Gopal Lifesciences (Unit-II)Himachal Pradesh | DisintegrationDisintegration | RDTL GuwahatiState lab | Nov 2022 |
| Paracetamol, Phenylephrine Hydrochloride, Caffeine and Diphenhydramine Hydrochloride (SNEZEE 500) | TP1020810Mfg 2020-10 · Exp 2022-09 | Maxrelief HealthcareHimachal Pradesh | Identification and AssayAssay | RDTL GuwahatiState lab | Apr 2022 |
| SNEZEE 500 TAB Paracetamol IP 500 mg Phenylephrine HCI IP 5 mg Caffeine IP 30 mg Diphenhydramine HCI IP 25 mg | TP-0121843Mfg 2021-01 · Exp 2022-12 | Maxrelief Health CareHimachal Pradesh | AssayAssay | RDTL GuwahatiState lab | Mar 2022 |
| DIPHENHYDRAMINE HYDROCHLORIDE, AMMONIUM CHLORIDE, SODIUM CITRATE AND MENTHOL SRYUP | LX-5435Mfg 2021-01 · Exp 2022-06 | LEGEN HEALTHCAREHimachal Pradesh | Assay of MentholAssay | RDTL ChandigarhCDSCO lab | May 2021 |
| Calamine, Diphenhydramine Hydrochloride and Camphor Lotion NANZIDRYL LOTION | NYL-002Mfg 2019-09 · Exp 2022-08 | Nanz Med Science Pharma Pvt. Ltd. (A unit of Med Science Canada Inc.)Himachal Pradesh | Assay of CamphorAssay | RDTL ChandigarhState lab | Dec 2020 |
Official sources and primary records
- AIR: Health ministry advises cough syrups should not be prescribed or dispensed to children below two yearsNewsAll India Radio · 4 October 2025
- AIR / PIB Fact Check: Govt dismisses rumours of ban on dextromethorphan cough syrupsPIBAll India Radio · 8 October 2025
- CDSCO: List of prohibited FDC drugs, 156 FDCs dated 02.08.2024RegulatorCDSCO · 2 August 2024