Diphenhydramine Hydrochloride
- Product NDC
- 54738-116
- 11-digit product format
- 547380116
- Labeler code
- 54738
- Product ID
- 54738-116_2a328f44-efc3-7e72-e063-6394a90a1d39
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Richmond Pharmaceuticals Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2000-02-15
- 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
- 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 | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | TC2D6JAD40 |
| Rxcui | 1020477, 1049909 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 54738-116-13 | Diphenhydramine Hydrochloride | 100 in 1 BOTTLE | CAPSULE | 100 | | 5 |
| 54738-116-01 | Diphenhydramine Hydrochloride | 100 in 1 BOTTLE | CAPSULE | 100 | | 2 |
| 54738-116-03 | Diphenhydramine Hydrochloride | 1000 in 1 BOTTLE | CAPSULE | 1000 | | 2 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54738-116 | DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [RICHMOND PHARMACEUTICALS INC.] | 5 | Current NDC, Legacy NDC, 1 package rows | 20241228_f184b2aa-91a4-44f9-b688-d4e318181984.zip |
| 54738-116 | DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [RICHMOND PHARMACEUTICALS, INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20171030_ab67121e-2477-47dd-a7ec-114453df3fd4.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 |
|---|
| 54738-116-01 | 54738011601 | 100 CAPSULE in 1 BOTTLE (54738-116-01) | 100 capsule | 2015-05-01 | 0000-00-00 | No | No | Current |
| 54738-116-03 | 54738011603 | 1000 CAPSULE in 1 BOTTLE (54738-116-03) | 1000 capsule | 2015-05-01 | 0000-00-00 | No | No | Current |
| 54738-116-13 | 54738011613 | 100 CAPSULE in 1 BOTTLE (54738-116-13) | 100 capsule | 2000-02-15 | 0000-00-00 | No | No | Current |