Daytime Cold and Flu
- Product NDC
- 51316-421
- 11-digit product format
- 513160421
- Labeler code
- 51316
- Product ID
- 51316-421_70d0e6d8-8206-4daa-b704-765e6d7f67a4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- CVS PHARMACY, INC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-05-31
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
- Active strength
- 325; 10 mg/15mL; mg/15mL
- Pharmacologic classes
- 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
- 2027-12-31
- 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
- Daytime Cold and Flu
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/15mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/15mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2604561 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1b8d5494-1fcf-4cd0-acc0-34f17d577bd7 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51316-421-12 | Daytime Cold and Flu | 355 mL in 1 BOTTLE, PLASTIC | LIQUID | 355 | 5 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Zicam Extreme Congestion Relief | OXYMETAZOLINE HYDROCHLORIDE | Church & Dwight Co., Inc. | ccada339-656c-a461-e053-2a95a90a3479 | 2025-12-31 | Warnings | M012 |
| ED A-HIST DM | DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE | EDWARDS PHARMACEUTICALS, INC. | e0e2b117-62bc-4132-9f7c-fe2a912052b1 | 2025-12-31 | Warnings | M012 |
| Bio-Z-Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Advanced Generic Corporation | 05e70eab-1467-4b09-991e-ef03f222e021 | 2025-12-31 | Warnings | M012 |
| Altipres-B | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Alternative Pharmacal Corporation | fd00c41d-0580-4177-afaa-60bb12ca5a09 | 2025-12-31 | Warnings | M012 |
| Ninjacof-D | CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE | Centurion Labs, LLC | 5188aa20-41f1-4998-81e1-f4de055874bc | 2025-12-31 | Warnings | M012 |
| Llorens Care Tussin DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Llorens Pharmaceutical International Division, Inc. | 4743e562-1217-50ab-e063-6394a90af88d | 2025-12-31 | Warnings | M012 |
| Llorens Care Tussin | GUAIFENESIN | Llorens Pharmaceutical International Division, Inc. | 474459c1-bfd7-dec7-e063-6394a90ac18d | 2025-12-31 | Warnings | M012 |
| Geri Care Tussin CF Max | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN | GERI-CARE PHARMACEUTICAL CORP | 4744669c-7f33-e35f-e063-6394a90a79b7 | 2025-12-31 | Warnings | M012 |
| Geri-Tussin | GUAIFENESIN | Geri-Care Pharmaceuticals, Corp | 65545ca3-4e93-4b59-9e17-4742e086e8e7 | 2025-12-31 | Warnings | M012 |
| GeriCare Tussin DM Max | DEXTROMETHORPHAN HBR, GUAIFENESIN | GERI-CARE PHARMACEUTICALS, CORP | 47451cd8-7aab-90e2-e063-6394a90ad1b7 | 2025-12-31 | Warnings | M012 |
| Curewell Tussin | GUAIFENESIN | RMT HEALTH LLC | 47455587-5074-e70d-e063-6294a90a78bb | 2025-12-31 | Warnings | M012 |
| Menthol Cough Drops | MENTHOL | Bestco Inc. | 77e25027-3c96-21fa-e053-2991aa0a1f31 | 2025-12-31 | Warnings | M012 |
| Puregen Labs Allergy Relief | DIPHENHYDRAMINE HCL | Advanced Rx LLC | 4745d4f9-bbdf-a4a6-e063-6294a90a15b2 | 2025-12-31 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION | 2a46ea9b-29e9-5197-e063-6394a90abc73 | 2025-12-31 | Warnings | M012 |
| Cherry Cough Drops | MENTHOL | Bestco Inc. | 77e50410-306d-b2fb-e053-2a91aa0af3c5 | 2025-12-31 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION | e086a6d2-f664-454e-9524-f656bfbf45df | 2025-12-31 | Warnings | M012 |
| Cherry Cough Drops | MENTHOL | Bestco Inc. | 77f45efb-8ee0-1186-e053-2991aa0a9884 | 2025-12-31 | Warnings | M012 |
| Conex Pediatric | DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL | Llorens Pharmaceutical International Division | 2a46af43-ef36-e14e-e063-6394a90a8285 | 2025-12-31 | Warnings | M012 |
| Conex | DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL | Llorens Pharmaceutical International Division | 2a343656-ac6d-8b20-e063-6294a90ab319 | 2025-12-31 | Warnings | M012 |
| Dologesic NF | ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE | Llorens Pharmaceutical International Division | 974fc0d5-7a99-46fb-af38-b91240f728fa | 2025-12-31 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2604561 | acetaminophen 650 MG / dextromethorphan HBr 20 MG in 30 mL Oral Solution | PSN | 1b8d5494-1fcf-4cd0-acc0-34f17d577bd7 | 5 |
| 2604561 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML Oral Solution | SCD | 1b8d5494-1fcf-4cd0-acc0-34f17d577bd7 | 5 |
| 2604561 | acetaminophen 325 MG / dextromethorphan HBr 10 MG per 15 ML Oral Solution | SY | 1b8d5494-1fcf-4cd0-acc0-34f17d577bd7 | 5 |
| 2604561 | acetaminophen 650 MG / dextromethorphan HBr 20 MG per 30 ML Oral Solution | SY | 1b8d5494-1fcf-4cd0-acc0-34f17d577bd7 | 5 |
| 2604561 | APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML Oral Solution | SY | 1b8d5494-1fcf-4cd0-acc0-34f17d577bd7 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 51316-421-12 | 51316042112 | 355 mL in 1 BOTTLE, PLASTIC (51316-421-12) | 355 ml | 2024-05-31 | No | No | Current |