nighttime sleep-aid
- Product NDC
- 69452-322
- 11-digit product format
- 694520322
- Labeler code
- 69452
- Product ID
- 69452-322_0d63c644-46c2-b4c0-e063-6394a90a9dd3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine HCl
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Bionpharma Inc.
- Application
- M010
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-04-27
- 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 |
|---|
| 69452-322-79 | nighttime sleep-aid | 160 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 160 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69452-322 | NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [BIONPHARMA INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20231226_c0074c77-287e-6c26-e053-2995a90a4d31.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69452-322-79 | 69452032279 | 160 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-322-79) | 2021-04-27 | 0000-00-00 | No | No | Current |