Medicine
Diphenhydramine 12.5 mg/5 mL oral solution
Diphenhydramine 12.5 mg/5 mL oral solution is a generic prescription medicine for oral use, made by 4 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Protect from freezing and light. Store at 20° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Diphenhydramine
- Brand
- Sold under the generic name
- Strength
- 12.5 mg/5 mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 1 bottle, 10 cartons, 10 trays and 4 more
- Manufacturers
- Camber PharmaceuticalsIndiaPAI PharmaMedical Purchasing SolutionsRedmont Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Protect from freezing and light. Store at 20° to 25°C (68° to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- D04AA32 Diphenhydramine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 10 February 1982
- Identifiers
- RxCUI 1049906DailyMed set ID 6fe6fe2d-4405-4e7a-a2ed-5eb367d52842, f808ee14-fccf-4abe-b53a-a40b0b3bba03, d8944f3c-acef-4ebe-9633-7d641ae95edf +1NDC 0121-0489, 31722-600, 31722-601 +3Application ANDA087513, ANDA219470
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle in 1 carton / 118 mL in 1 bottle | 31722-600-11 | Camber PharmaceuticalsIndia | 17 June 2026 |
| 10 carton in 1 box / 10 cup, unit-dose in 1 carton / 5 mL in 1 cup, unit-dose | 31722-600-31 | Camber PharmaceuticalsIndia | 17 June 2026 |
| 10 carton in 1 box / 10 cup, unit-dose in 1 carton / 10 mL in 1 cup, unit-dose | 31722-601-31 | Camber PharmaceuticalsIndia | 17 June 2026 |
| 10 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 0121-0489-00 | PAI Pharma | 10 February 1982 |
| 10 tray in 1 case / 10 cup, unit-dose in 1 tray / 10 mL in 1 cup, unit-dose | 0121-0978-00 | PAI Pharma | 10 February 1982 |
| 118 mL in 1 bottle | 71741-511-04 | Redmont Pharmaceuticals | 22 July 2026 |
| 1 cup, unit-dose in 1 bag / 10 mL in 1 cup, unit-dose | 71872-7242-1 | Medical Purchasing Solutions | 1 March 2021 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 4 March 1946 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Diphenhydramine
Clinical summary
Diphenhydramine is a histamine-1 receptor antagonist. It is available as injection and oral solution for intramuscular and intravenous use. MedsAcross supplies Diphenhydramine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about DiphenhydramineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Diphenhydramine HCL prescribing information (Redmont Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Diphenhydramine 12.5 mg/5 mL oral solution for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.