Nighttime Sleep Aid
- Product NDC
- 83059-0028
- 11-digit product format
- 830590028
- Labeler code
- 83059
- Product ID
- 83059-0028_427692e6-4ddc-e642-e063-6394a90a25d0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine Hydrochloride
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Shield Pharmaceuticals Corp
- Application
- M010
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-04-08
- 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 |
|---|
| 83059-0028-8 | Nighttime Sleep Aid | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | | 4 |
| 83059-0028-8 | Nighttime Sleep Aid | 8 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 8 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83059-0028 | NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [SHIELD PHARMACEUTICALS CORP] | 3 | Current NDC, 2 package rows | 20241228_ab825826-d911-4a0f-9d5c-5ee2f242b893.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 |
|---|
| 83059-0028-8 | 83059002808 | 1 BOTTLE in 1 CARTON (83059-0028-8) / 8 CAPSULE, LIQUID FILLED in 1 BOTTLE | 1 bottle | 2024-04-08 | No | No | Current |