Nuvicare NightTime Cold and Flu Softgel
- Product NDC
- 84324-019
- 11-digit product format
- 843240019
- Labeler code
- 84324
- Product ID
- 84324-019_926db391-146a-4f73-9f00-48ebde363099
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, Doxylamine succinate
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- NUVICARE LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-05-20
- 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
- Nuvicare NightTime Cold and Flu Softgel
- 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 |
|---|
| 84324-019-01 | Nuvicare NightTime Cold and Flu Softgel | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | | 1 |
| 84324-019-01 | Nuvicare NightTime Cold and Flu Softgel | 10 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 10 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 84324-019 | NUVICARE NIGHTTIME COLD AND FLU SOFTGEL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [NUVICARE LLC] | 1 | Current NDC, 2 package rows | 20250522_37a88914-6234-4191-86f5-103c396c52af.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 84324-019-01 | 84324001901 | 1 BLISTER PACK in 1 CARTON (84324-019-01) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 1 blister pack | 2025-05-20 | No | No | Current |