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 |
|---|---|---|---|---|---|---|
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | Marc Glassman, Inc. | e916ef86-ca73-42dd-83dc-6033f56d96f2 | 2025-12-19 | Warnings | M012 |
| Original Night-Time MULTI-SYMPTOM COLD/FLU RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Discount Drug Mart | e243033b-6603-4c3e-a330-e7c7de51f69d | 2025-12-19 | Warnings | M012 |
| CHILDRENS ALLERGY | DIPHENHYDRAMINE HYDROCHLORIDE | Discount Drug Mart | 6fa4f913-de83-4175-9dad-0dedab5b69a1 | 2025-12-19 | Warnings | M012 |
| Day-Time COLD/FLU RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL | Discount Drug Mart | 426db906-9aa4-448f-a361-09c1516efc25 | 2025-12-19 | Warnings | M012 |
| MAXIUM STRENGTH SEVERE CONGESTION and COUGH MAX | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Discount Drug Mart | f17385bc-82bb-4183-a4c9-067d8afb3757 | 2025-12-19 | Warnings | M012 |
| MAXIUM STRENGTH DM MAX | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Discount Drug Mart | 9654fdcd-d660-471f-bc5d-aa7dead7a4a8 | 2025-12-19 | Warnings | M012 |
| Night Time Multi-Symptom Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Discount Drug Mart | 8148c2b1-f6ec-4597-8e18-a6597cda5705 | 2025-12-19 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL 25 MG | NUVICARE LLC | 621ba20e-75c5-42fb-9692-7800f764c978 | 2025-12-19 | Warnings | M012 |
| Nasal Decongestant PE | PHENYLEPHRINE HCL 10 MG | NUVICARE LLC | 4cde41dd-a0a7-45e7-aff3-ee9402dfdff2 | 2025-12-19 | Warnings | M012 |
| COMBINATION PACK TopCare health DayTime SEVERE and NiteTime SEVERE Cold and Flu Relief SOFTGELS - 24 ct | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | ceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e | 2025-12-19 | Warnings | M012 |
| NeoTuss S/F Grape-Menthol Flavor | GUAIFENESIN, DEXTROMETHORPHAN HBR | DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals | 2f3df82c-1926-5238-e063-6294a90a7bbf | 2025-12-18 | Warnings | M012 |
| NeoTuss S/F Grape-Menthol Flavor | GUAIFENESIN, DEXTROMETHORPHAN HBR | DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals | 2fac3425-32f0-38d6-e063-6394a90a6e7a | 2025-12-18 | Warnings | M012 |
| NAFASOLINA | NAPHAZOLINE HYDROCHLORIDE | Doral Pharmamedics Inc DBA AG Marin Pharmaceuticals | 30cade3d-208f-8594-e063-6394a90ad2a0 | 2025-12-18 | Warnings | M012 |
| Honey Lemon Flavor Cough Drop | HONEY LEMON FLAVOR COUGH DROP | Army & Air Force Exchange Service | 20ac8a20-206c-0024-e063-6394a90a9d06 | 2025-12-18 | Warnings | M012 |
| Menthol Flavor Cough Drop | MENTHOL FLAVOR COUGH DROP | Army & Air Force Exchange Service | 20ace10f-4257-b20e-e063-6394a90a3c7b | 2025-12-18 | Warnings | M012 |
| NeoTuss Plus | DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals | 2fabd782-14dc-1d1b-e063-6394a90af428 | 2025-12-18 | Warnings | M012 |
| NeoTuss Plus | DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals | 2f3c6b38-7236-899b-e063-6294a90aabde | 2025-12-18 | Warnings | M012 |
| QUALITY CHOICE Cough Drops Black Cherry SUGAR FREE | MENTHOL | Chain Drug Marketing Association, Inc. | 8f6ee01c-baad-489f-b2fd-0ef506916ee4 | 2025-12-18 | Warnings | M012 |
| menthol cough drops | MENTHOL | Meijer | 5baeaff7-172c-187a-e053-2a91aa0ab165 | 2025-12-18 | Warnings | M012 |
| Menthol Cough Drops | MENTHOL | Meijer Distribution Inc. | 3bee752a-4141-1f5b-e054-00144ff8d46c | 2025-12-18 | 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 |