Nighttime SLEEP AID
- Product NDC
- 51013-817
- 11-digit product format
- 510130817
- Labeler code
- 51013
- Product ID
- 51013-817_272a7138-2a98-8e62-e063-6394a90a1af1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine HCl 50mg
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- PuraCap Pharmaceutical LLC
- Application
- M010
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-11-30
- 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
- Nighttime SLEEP AID
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51013-817-01 | Nighttime SLEEP AID | 100 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 100 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51013-817 | NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL 50MG) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC] | 1 | Current NDC, 1 package rows | 20241130_272a7138-2a97-8e62-e063-6394a90a1af1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 51013-817-01 | 51013081701 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (51013-817-01) | 2024-11-30 | No | No | Current |