NIGHTTIME COLD AND FLU RELIEF
- Product NDC
- 68016-878
- 11-digit product format
- 680160878
- Labeler code
- 68016
- Product ID
- 68016-878_154cdb7a-60b0-4e36-9b1d-c579f7bf1a0d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Chain Drug Consortium, LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-07-12
- 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
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- NIGHTTIME COLD AND FLU RELIEF
- Listing expiration
- 2026-12-31
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 |
|---|
| 68016-878-16 | NIGHTTIME COLD AND FLU RELIEF | 8 in 1 CARTON | CAPSULE | 8 | | 3 |
| 68016-878-16 | NIGHTTIME COLD AND FLU RELIEF | 2 in 1 BLISTER PACK | CAPSULE | 2 | | 3 |
| 68016-878-24 | NIGHTTIME COLD AND FLU RELIEF | 2 in 1 BLISTER PACK | CAPSULE | 2 | | 3 |
| 68016-878-24 | NIGHTTIME COLD AND FLU RELIEF | 12 in 1 CARTON | CAPSULE | 12 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68016-878 | NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE) CAPSULE [CHAIN DRUG CONSORTIUM, LLC] | 3 | Current NDC, Legacy NDC, 4 package rows | 20241025_1deb60f3-e9be-4756-b0c1-527ef00dc741.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 |
|---|
| 68016-878-16 | 68016087816 | 8 BLISTER PACK in 1 CARTON (68016-878-16) / 2 CAPSULE in 1 BLISTER PACK | 8 blister pack | 2019-07-12 | 0000-00-00 | No | No | Current |
| 68016-878-24 | 68016087824 | 12 BLISTER PACK in 1 CARTON (68016-878-24) / 2 CAPSULE in 1 BLISTER PACK | 12 blister pack | 2019-07-12 | 0000-00-00 | No | No | Current |