diphenhydramine hydrochloride
- Product NDC
- 76457-002
- 11-digit product format
- 764570002
- Labeler code
- 76457
- Product ID
- 76457-002_0b586170-9b5f-74dc-e063-6394a90aa09b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- DIPHENHYDRAMINE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Simpex Pharma Pvt. Ltd
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-02-09
- Substance
- DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- diphenhydramine hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | TC2D6JAD40 |
| Rxcui | 1049630 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76457-002-00 | diphenhydramine hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 5 |
| 76457-002-00 | diphenhydramine hydrochloride | 1 in 1 CARTON | TABLET | 1 | | 5 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76457-002 | DIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD] | 5 | Current NDC, Legacy NDC, 2 package rows | 20231201_82771f6a-8b3d-4ffa-8b35-09c2faf3582c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 76457-002-00 | 76457000200 | 1 BOTTLE in 1 CARTON (76457-002-00) / 100 TABLET in 1 BOTTLE | 1 bottle | 2018-02-09 | 0000-00-00 | No | No | Current |