Nuvicare NightTime Cold and Flu Softgel
- Product NDC
- 84324-024
- 11-digit product format
- 843240024
- Labeler code
- 84324
- Product ID
- 84324-024_baf65fbc-067d-4642-9612-93cc416b5639
- 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
- 2025-06-09
- 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 |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 15 mg/1 |
| DOXYLAMINE SUCCINATE | 6.25 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2 |
| Rxcui | 1094549 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 84324-024-01 | Nuvicare NightTime Cold and Flu Softgel | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | 1 | |
| 84324-024-01 | Nuvicare NightTime Cold and Flu Softgel | 10 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 10 | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2634564 | {1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule) } Pack | GPCK | f5764925-c586-40e4-8252-24d92389af01 | 1 |
| 2634564 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) Pack | PSN | f5764925-c586-40e4-8252-24d92389af01 | 1 |
| 1086997 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | f5764925-c586-40e4-8252-24d92389af01 | 1 |
| 1094549 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule | PSN | 2a29f0ed-d86b-4787-84e0-f7a8c5e7581f | 1 |
| 1094549 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule | PSN | f5764925-c586-40e4-8252-24d92389af01 | 1 |
| 1086997 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | f5764925-c586-40e4-8252-24d92389af01 | 1 |
| 1094549 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | 2a29f0ed-d86b-4787-84e0-f7a8c5e7581f | 1 |
| 1094549 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | f5764925-c586-40e4-8252-24d92389af01 | 1 |
| 2634564 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) Pack | SY | f5764925-c586-40e4-8252-24d92389af01 | 1 |
| 1086997 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SY | f5764925-c586-40e4-8252-24d92389af01 | 1 |
| 1094549 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | 2a29f0ed-d86b-4787-84e0-f7a8c5e7581f | 1 |
| 1094549 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | f5764925-c586-40e4-8252-24d92389af01 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 84324-024-01 | 84324002401 | 1 BLISTER PACK in 1 CARTON (84324-024-01) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 1 blister pack | 2025-06-09 | No | No | Current |