NIGHTTIME SLEEP AID
- Product NDC
- 68210-4160
- 11-digit product format
- 682104160
- Labeler code
- 68210
- Product ID
- 68210-4160_494914ff-a952-e7f9-e063-6294a90a88e1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- DIPHENHYDRAMINE HYDROCHLORIDE
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Prodose, Inc.
- Application
- M010
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-06-14
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- NIGHTTIME SLEEP AID
- Listing expiration
- 2027-12-31
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 |
|---|
| 68210-4160-8 | NIGHTTIME SLEEP AID | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | | 6 |
| 68210-4160-8 | NIGHTTIME SLEEP AID | 8 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 8 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68210-4160 | NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241215_c4bc3efd-8ca8-22fe-e053-2a95a90aed45.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68210-4160-8 | 68210416008 | 1 BLISTER PACK in 1 CARTON (68210-4160-8) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 1 blister pack | 2021-06-14 | 0000-00-00 | No | No | Current |