Nighttime Sleep-Aid
- Product NDC
- 53041-633
- 11-digit product format
- 530410633
- Labeler code
- 53041
- Product ID
- 53041-633_329d343f-2056-4870-930c-348917bfb2bc
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine HCl
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Guardian Drug Company
- Application
- part338
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-01-11
- Substance
- DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 50 mg/30mL
- 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/30mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | TC2D6JAD40 |
| Rxcui | 1248354 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53041-633-58 | Nighttime Sleep-Aid | 177 mL in 1 BOTTLE | LIQUID | 177 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53041-633 | NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) LIQUID [GUARDIAN DRUG COMPANY] | 1 | Current NDC, 1 package rows | 20240113_329d343f-2056-4870-930c-348917bfb2bc.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 53041-633-58 | 53041063358 | 177 mL in 1 BOTTLE (53041-633-58) | 177 ml | 2024-01-11 | No | No | Historical |