Diphenhydramine hydrochloride
- Product NDC
- 35916-0472
- 11-digit product format
- 359160472
- Labeler code
- 35916
- Product ID
- 35916-0472_47db0e8e-5351-a9ae-e063-6394a90aba50
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine hydrochloride
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Softgel Healthcare Pvt Ltd
- Application
- M010
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-04-08
- Substance
- DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Diphenhydramine hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | TC2D6JAD40 |
| Rxcui | 1020477 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 35916-0472-1 | Diphenhydramine hydrochloride | 1000 in 1 BAG | CAPSULE, LIQUID FILLED | 1000 | | 3 |
| 35916-0472-2 | Diphenhydramine hydrochloride | 3000 in 1 POUCH | CAPSULE, LIQUID FILLED | 3000 | | 3 |
| 35916-0472-2 | Diphenhydramine hydrochloride | 2 in 1 BOX | CAPSULE, LIQUID FILLED | 2 | | 3 |
| 35916-0472-3 | Diphenhydramine hydrochloride | 2 in 1 BOX | CAPSULE, LIQUID FILLED | 2 | | 3 |
| 35916-0472-3 | Diphenhydramine hydrochloride | 1500 in 1 BAG | CAPSULE, LIQUID FILLED | 1500 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 35916-0472 | DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED [SOFTGEL HEALTHCARE PVT LTD] | 1 | Current NDC, 5 package rows | 20250410_32033991-a4f0-f767-e063-6394a90a0b06.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 35916-0472-1 | 35916047201 | 1000 CAPSULE, LIQUID FILLED in 1 BAG (35916-0472-1) | | 2025-04-08 | No | No | Current |
| 35916-0472-2 | 35916047202 | 2 POUCH in 1 BOX (35916-0472-2) / 3000 CAPSULE, LIQUID FILLED in 1 POUCH | 2 pouch | 2025-07-16 | No | No | Current |
| 35916-0472-3 | 35916047203 | 2 BAG in 1 BOX (35916-0472-3) / 1500 CAPSULE, LIQUID FILLED in 1 BAG | 2 bag | 2026-01-24 | No | No | Current |