Diphenhydramine Hydrochloride
- Product NDC
- 51316-835
- 11-digit product format
- 513160835
- Labeler code
- 51316
- Product ID
- 51316-835_28513391-e715-29a1-e063-6394a90a0340
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- CVS Pharmacy, Inc
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-11-16
- 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 | 1049909 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51316-835-01 | Diphenhydramine Hydrochloride | 1 in 1 CARTON | CAPSULE | 1 | | 2 |
| 51316-835-01 | Diphenhydramine Hydrochloride | 100 in 1 BOTTLE | CAPSULE | 100 | | 2 |
| 51316-835-03 | Diphenhydramine Hydrochloride | 4 in 1 CARTON | CAPSULE | 4 | | 2 |
| 51316-835-03 | Diphenhydramine Hydrochloride | 12 in 1 BLISTER PACK | CAPSULE | 12 | | 2 |
| 51316-835-07 | Diphenhydramine Hydrochloride | 365 in 1 BOTTLE | CAPSULE | 365 | | 2 |
| 51316-835-08 | Diphenhydramine Hydrochloride | 2 in 1 CARTON | CAPSULE | 2 | | 2 |
| 51316-835-08 | Diphenhydramine Hydrochloride | 12 in 1 BLISTER PACK | CAPSULE | 12 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51316-835 | DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [CVS PHARMACY, INC] | 2 | Current NDC, 7 package rows | 20241208_f4468840-e17c-6888-e053-2995a90a04a0.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 |
|---|
| 51316-835-01 | 51316083501 | 1 BOTTLE in 1 CARTON (51316-835-01) / 100 CAPSULE in 1 BOTTLE | 1 bottle | 2022-12-01 | No | No | Historical |
| 51316-835-03 | 51316083503 | 4 BLISTER PACK in 1 CARTON (51316-835-03) / 12 CAPSULE in 1 BLISTER PACK | 4 blister pack | 2022-12-01 | No | No | Historical |
| 51316-835-07 | 51316083507 | 365 CAPSULE in 1 BOTTLE (51316-835-07) | 365 capsule | 2022-11-23 | No | No | Historical |
| 51316-835-08 | 51316083508 | 2 BLISTER PACK in 1 CARTON (51316-835-08) / 12 CAPSULE in 1 BLISTER PACK | 2 blister pack | 2022-11-16 | No | No | Historical |