NIGHTTIME COLD AND FLU RELIEF
- Product NDC
- 58602-769
- 11-digit product format
- 586020769
- Labeler code
- 58602
- Product ID
- 58602-769_ce31ced0-439e-4668-94aa-fd09cc636669
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aurohealth LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-06-29
- 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 |
|---|
| 58602-769-78 | NIGHTTIME COLD AND FLU RELIEF | 8 in 1 BLISTER PACK | CAPSULE | 8 | | 4 |
| 58602-769-78 | NIGHTTIME COLD AND FLU RELIEF | 3 in 1 CARTON | CAPSULE | 3 | | 4 |
| 58602-769-79 | NIGHTTIME COLD AND FLU RELIEF | 1 in 1 CARTON | CAPSULE | 1 | | 4 |
| 58602-769-79 | NIGHTTIME COLD AND FLU RELIEF | 8 in 1 BLISTER PACK | CAPSULE | 8 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58602-769 | NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE) CAPSULE [AUROHEALTH LLC] | 4 | Current NDC, Legacy NDC, 4 package rows | 20250510_70e1bd25-c32e-491f-b383-91d6f74957a0.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 |
|---|
| 58602-769-15 | 58602076915 | 16 CAPSULE in 1 BOTTLE (58602-769-15) | 16 capsule | 2019-12-31 | 0000-00-00 | No | No | Current |
| 58602-769-78 | 58602076978 | 3 BLISTER PACK in 1 CARTON (58602-769-78) / 8 CAPSULE in 1 BLISTER PACK | 3 blister pack | 2024-06-29 | | No | No | Current |
| 58602-769-79 | 58602076979 | 1 BLISTER PACK in 1 CARTON (58602-769-79) / 8 CAPSULE in 1 BLISTER PACK | 1 blister pack | 2024-06-29 | | No | No | Current |