DIPHENHYDRAMINE HYDROCHLORIDE
- Product NDC
- 35916-0438
- 11-digit product format
- 359160438
- Labeler code
- 35916
- Product ID
- 35916-0438_47c5b5fc-5f4a-cd15-e063-6294a90a45aa
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- DIPHENHYDRAMINE HYDROCHLORIDE
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- SOFTGEL HEALTHCARE PRIVATE LIMITED
- Application
- M010
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-01-10
- 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 |
|---|
| 35916-0438-1 | DIPHENHYDRAMINE HYDROCHLORIDE | 100 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 100 | | 4 |
| 35916-0438-3 | DIPHENHYDRAMINE HYDROCHLORIDE | 1000 in 1 BAG | CAPSULE, LIQUID FILLED | 1000 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 35916-0438 | DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED [SOFTGEL HEALTHCARE PVT LTD] | 3 | Current NDC, 2 package rows | 20250308_0e45d0e8-3741-7cee-e063-6394a90a2de5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 35916-0438-1 | 35916043801 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (35916-0438-1) | 2024-01-11 | No | No | Current |
| 35916-0438-3 | 35916043803 | 1000 CAPSULE, LIQUID FILLED in 1 BAG (35916-0438-3) | 2025-03-01 | No | No | Current |