Nighttime Sleep Aid
- Product NDC
- 68391-613
- 11-digit product format
- 683910613
- Labeler code
- 68391
- Product ID
- 68391-613_3c10ec86-2536-00f5-e063-6394a90a244c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine Hydrochloride
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- BJWC (Berkley & Jensen / BJ's)
- Application
- M010
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-08-20
- 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 | 1049909 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68391-613-92 | Nighttime Sleep Aid | 12 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 12 | | 2 |
| 68391-613-92 | Nighttime Sleep Aid | 16 in 1 CARTON | CAPSULE, LIQUID FILLED | 16 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68391-613-92 | 68391061392 | 16 BLISTER PACK in 1 CARTON (68391-613-92) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 16 blister pack | 2025-08-20 | No | No | Current |