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
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| V9BI9B5YI2 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1094549 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2a29f0ed-d86b-4787-84e0-f7a8c5e7581f | Available on FDA.report |
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 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| CareOne Fast Acting Nasal | PHENYLEPHRINE HYDROCHLORIDE | American Sales Company | 95b22dce-ef54-4ab5-9cc3-0e1cefa09ec5 | 2024-10-24 | Warnings | M012 |
| DAYTIME COLD AND FLU MULTI-SYMPTOM RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Chain Drug Consortium, LLC | 8cb0d0c8-c565-4c5a-97c5-8250a67e23a8 | 2024-10-24 | Warnings | M012 |
| equate nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Wal-Mart Stores Inc | 0d07a534-c67f-4041-a07c-ed7f68dfc426 | 2024-10-23 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Marc Glassman, Inc. | 90977b39-8ced-46bf-9d06-15306bce9b35 | 2024-10-23 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Marc Glassman, Inc. | 5d29d3e3-3666-4a2f-835f-9e01bf8f5eeb | 2024-10-23 | Warnings | M012 |
| Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | MARC GLASSMAN, INC. | e2325f33-e4e4-1269-e053-2995a90ab4ac | 2024-10-23 | Warnings | M012 |
| Sinus Pressure plus Pain PE | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | MARC GLASSMAN, INC. | a8240d98-f0b0-3ded-e053-2a95a90a5cf9 | 2024-10-23 | Warnings | M012 |
| Sinus plus Headache | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | MARC GLASSMAN, INC. | a82401f5-65b1-11e9-e053-2a95a90a499e | 2024-10-23 | Warnings | M012 |
| Allergy Multi Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE | MARC GLASSMAN, INC. | a823db21-4863-45a6-e053-2995a90ab8e6 | 2024-10-23 | Warnings | M012 |
| Cold Max | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | MARC GLASSMAN, INC. | e2346d0c-75cf-974c-e053-2a95a90a2857 | 2024-10-23 | Warnings | M012 |
| Cold Multi-Symptom Nighttime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Marc Glassman, Inc. | ce573785-f77d-4314-9b7a-ef3f1f4f34d8 | 2024-10-23 | Warnings | M012 |
| Cold plus Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | MARC GLASSMAN, INC. | e41a3dcc-45b4-4093-e053-2995a90a3b14 | 2024-10-23 | Warnings | M012 |
| Cold plus Head Congestion Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | MARC GLASSMAN, INC. | e41a7cc5-bd0e-b92b-e053-2995a90af50a | 2024-10-23 | Warnings | M012 |
| Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Kroger Company | 1cd26a6a-4b50-4610-9fc8-278545d77f18 | 2024-10-23 | Warnings | M012 |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | CVS Pharmacy | c5dd40e5-b4e2-4963-9a53-b71da1ed5510 | 2024-10-23 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Harris Teeter | 832eb36c-21c6-46d7-b1f8-ab8b6f1e501e | 2024-10-22 | Warnings | M012 |
| Sinus plus Headache | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | Harris Teeter | c9d82968-b2ec-2f4b-e053-2a95a90a7f0c | 2024-10-22 | Warnings | M012 |
| Cold Max | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Harris Teeter | b9d9ab99-44b1-455f-a29a-95c193a4808e | 2024-10-22 | Warnings | M012 |
| Mucus Relief Sinus Severe Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HARRIS TEETER | b96c376e-578f-1124-e053-2a95a90acbb4 | 2024-10-22 | Warnings | M012 |
| Tukol Honey Daytime and Nighttime Value Pack | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE | Genomma Lab USA | bccc11d2-d227-4cbb-b0fc-ac6abb6dce57 | 2024-10-22 | Warnings | M012 |
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 |