Nighttime Sleep Aid
- Product NDC
- 69517-004
- 11-digit product format
- 695170004
- Labeler code
- 69517
- Product ID
- 69517-004_3f9bfb90-0d2f-16d1-e063-6394a90ac914
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine HCl
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- HealthLife of USA LLC
- Application
- M010
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-09-25
- 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 |
|---|
| 69517-004-03 | Nighttime Sleep Aid | 300 in 1 BOTTLE | TABLET, COATED | 300 | | 1 |
| 69517-004-06 | Nighttime Sleep Aid | 600 in 1 BOTTLE | TABLET, COATED | 600 | | 1 |
| 69517-004-10 | Nighttime Sleep Aid | 1000 in 1 BOTTLE | TABLET, COATED | 1000 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 69517-004-03 | 69517000403 | 300 TABLET, COATED in 1 BOTTLE (69517-004-03) | 2025-09-25 | No | No | Current |
| 69517-004-06 | 69517000406 | 600 TABLET, COATED in 1 BOTTLE (69517-004-06) | 2025-09-25 | No | No | Current |
| 69517-004-10 | 69517000410 | 1000 TABLET, COATED in 1 BOTTLE (69517-004-10) | 2025-09-25 | No | No | Current |