Nighttime Cold and Flu Relief
- Product NDC
- 68016-798
- 11-digit product format
- 680160798
- Labeler code
- 68016
- Product ID
- 68016-798_626c06b7-ec9a-42c1-a421-e75f22b64f99
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Chain Drug Consortium, LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-09-15
- Marketing end
- 2026-06-30
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
- Active strength
- 325; 15; 6.25 mg/1; mg/1; mg/1
- Pharmacologic classes
- Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nighttime Cold and Flu Relief
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 15 mg/1 |
| DOXYLAMINE SUCCINATE | 6.25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2 |
| Rxcui | 1094549 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68016-798-16 | Nighttime Cold and Flu Relief | 1 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 1 | | 4 |
| 68016-798-16 | Nighttime Cold and Flu Relief | 16 in 1 CARTON | CAPSULE, LIQUID FILLED | 16 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68016-798 | NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] | 2 | Current NDC, Legacy NDC, 2 package rows | 20240308_e69f1709-5fd6-4de4-b171-2fdfc744cfe6.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 |
|---|
| 68016-798-16 | 68016079816 | 16 BLISTER PACK in 1 CARTON (68016-798-16) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 16 blister pack | 2022-09-15 | 2026-06-30 | No | No | Current |