Brand check

Is Benadryl banned in India?

Last checked 1 October 2026

Benadryl. Status: Not banned.

Benadryl cough syrup is not banned in India as of 1 Oct 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
Evidence
Government document
Latest action
8 October 2025
Last checked
1 October 2026

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.

Primary government sourceTier 1: government primary source

CDSCO: List of prohibited FDC drugs, 156 FDCs dated 02.08.2024

CDSCO / Ministry of Health and Family Welfare · No Section 26A notification; DGHS advisory 4 Oct 2025 on cough syrups for children under 2 · 2 August 2024

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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 Always check the linked government document for the current position, and tell us if something is out of date.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)
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. Manufacturers do change formulas, so check the current label.

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, Caffeine & Diphenhydramine Hydrochloride Tablets Batch DHPLT/030725Mfg Jul 2025 · Exp Jun 2027 Durgaji Healthcare Pvt.LtdUttarakhand The sample does not conform to claim as per Schedule V, Drugs & Cosmetics Acts and rules 1945 with respect to test for 'Disintegration Time' and is also not of standard quality for the reason stated under 'Description'.Description CDL, KolkataCDSCO lab Sep 2026
Paracetamol Phenylepherine Hydrochloride Caffine (Anhydrous) Diphenhydramine Hydrochloride Batch T-2511129Mfg Nov 2025 · Exp Oct 2027 Aagya Biotech Pvt. Ltd. 1.5 kmUttarakhand DescriptionDescription SDT&RL, BhubanesearState lab Sep 2026
Diphenhydramine HCl, Ammonium Chloride, Sodium Citrate and Menthol Syrup 50 ml Batch 26007Mfg Feb 2026 · Exp Jan 2028 Riemann Labs Pvt. LtdMadhya Pradesh The sample does not conform to claim as per Patent and Proprietary in respect to the Assay of MentholAssay RDTL, ChandigarhCDSCO lab Sep 2026
Paracetamol, Phenylephrine Hydrochloride, Caffeine & Diphenhydramine Hydrochloride Tablets Batch GAB4135Mfg Dec 2025 · Exp Nov 2027 Aagya Biotech Pvt. Ltd. 1.5 kmUttarakhand The sample does not conforms to declared formula in respect of disintegration of tabletsDisintegration LUCKNOW LABState lab Aug 2026
Paracetamol, Phenylephrine Hydrochloride Diphenhydramine, Hydrocloride & Caffeine Tablets Batch YLT25023Mfg Jun 2025 · Exp May 2027 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 Batch B46826001Mfg Jan 2026 · Exp Dec 2027 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 Batch S285011Mfg Apr 2025 · Exp Mar 2027 Goa Antibiotics & Pharmaceuticals LtdGoa 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 Batch 2519031L002Mfg Dec 2025 · Exp Nov 2027 Scott-Edil Pharmacia LtdHimachal 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 Batch ZRSL - 1806Mfg Sep 2025 · Exp Aug 2027 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 Batch YLT25006Mfg Jan 2025 · Exp Dec 2026 YL PharmaHimachal Pradesh Identification & AssayAssay DTL ,Baddi, HPState lab Sep 2025
Diphenhydramine Hydrochloride Capsules IP 25 mg Batch C 364Mfg Feb 2024 · Exp Jan 2026 Bittu Pharmaceuticals (II)Maharashtra DissolutionDissolution State Lab KarnatakaState lab Jun 2025
Diphenhydramine Hydrochloride, Ammonium Chloride, Sodium Citrate & Menthol Syrup (Beedryl Plus) Batch 40183Mfg Feb 2024 · Exp Jan 2026 Zenith Drugs Ltd. 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) Batch 40186Mfg Feb 2024 · Exp Jan 2026 Zenith Drugs Ltd. 72/5 & 72/3Madhya Pradesh Assay of Menthol and DescriptionAssay CDL KolkataCDSCO lab Dec 2024
Diphenhydramine Hydrochloride Capsules IP (XL Dryl-D Capsules) Batch CPD240100 6Mfg Jan 2024 · Exp Dec 2025 Caspian PharmaceuticalsHimachal Pradesh Dissolution and Assay of Diphenhydramin e HydrochlorideAssay RDTL ChandigarhCDSCO lab Apr 2024
Diphenhydramine Hydrochloride, Ammonium Chloride, Sodium Citrate & Menthol Syrup Batch ML220730Mfg Dec 2022 · Exp Nov 2024 Mascot Health Series Pvt. LtdUttarakhand Assay/content of MentholAssay CDL KolkataCDSCO lab Nov 2023
Paracetamol, Phenylphrine Hydrochloride, Diphenhydramine Hydrochloride and Caffeine Tablets (Syscold Tablets) Batch SPT?192Mfg Jan 2022 · Exp Dec 2023 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 Batch LDS2005ALMfg Dec 2022 · Exp May 2024 Hindustan Laboratories LimitedMaharashtra Assay of MentholAssay RDTL ChandigarhCDSCO lab Mar 2023
PCD COLD� (Paracetamol, Phenylephrine HCl, Caffeine & Diphenhydramine HCl Tablets) Batch GLT-21213Mfg Mar 2021 · Exp Feb 2024 Gopal LifesciencesHimachal Pradesh DisintegrationDisintegration RDTL GuwahatiState lab Nov 2022
Paracetamol, Phenylephrine Hydrochloride, Caffeine and Diphenhydramine Hydrochloride (SNEZEE 500) Batch TP1020810Mfg Oct 2020 · Exp Sep 2022 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 Batch TP-0121843Mfg Jan 2021 · Exp Dec 2022 Maxrelief HealthcareHimachal Pradesh AssayAssay RDTL GuwahatiState lab Mar 2022
Showing 20 of 22 records

Ingredient records: Diphenhydramine

Sources

Government documents

News reports