NIGHTTIME COLD AND FLU RELIEF SOFTGELS
- Product NDC
- 80513-302
- 11-digit product format
- 805130302
- Labeler code
- 80513
- Product ID
- 80513-302_220d53b9-4208-092d-e063-6394a90a9b0a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE
- Dosage form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Labeler
- Advanced Rx LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-04-24
- 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 SOFTGELS
- Brand name suffix
- MULTI-SYMPTOM
- 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 |
|---|
| 80513-302-50 | NIGHTTIME COLD AND FLU RELIEF SOFTGELSMULTI-SYMPTOM | 50 in 1 BOTTLE | CAPSULE, GELATIN COATED | 50 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80513-302 | NIGHTTIME COLD AND FLU RELIEF SOFTGELS MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [ADVANCED RX LLC] | 4 | Current NDC, 1 package rows | 20240918_fa1b60b1-49cb-1211-e053-6394a90a0a46.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 80513-302-50 | 80513030250 | 50 CAPSULE, GELATIN COATED in 1 BOTTLE (80513-302-50) | 2023-04-24 | No | No | Current |