Nighttime Sleep Aid
- Product NDC
- 71679-110
- 11-digit product format
- 716790110
- Labeler code
- 71679
- Product ID
- 71679-110_37d37296-6f58-cb2f-e063-6394a90adfbc
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine HCl 25 mg
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Health Pharma USA LLC
- Application
- M010
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-06-18
- 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
- Nighttime Sleep Aid
- 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 |
|---|
| 71679-110-03 | Nighttime Sleep Aid | 300 in 1 BOTTLE | TABLET, COATED | 300 | | 11 |
| 71679-110-06 | Nighttime Sleep Aid | 600 in 1 BOTTLE | TABLET, COATED | 600 | | 11 |
| 71679-110-10 | Nighttime Sleep Aid | 1000 in 1 BOTTLE | TABLET, COATED | 1000 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71679-110 | NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL 25 MG) TABLET, COATED [HEALTH PHARMA USA LLC] | 5 | Current NDC, Legacy NDC, 3 package rows | 20231031_d659f747-9790-8bd6-e053-2995a90ae793.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 |
|---|
| 71679-110-03 | 71679011003 | 300 TABLET, COATED in 1 BOTTLE (71679-110-03) | 2025-06-18 | | No | No | Historical |
| 71679-110-06 | 71679011006 | 600 TABLET, COATED in 1 BOTTLE (71679-110-06) | 2025-06-18 | 0000-00-00 | No | No | Current |
| 71679-110-10 | 71679011010 | 1000 TABLET, COATED in 1 BOTTLE (71679-110-10) | 2025-06-18 | 0000-00-00 | No | No | Current |