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
- 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
- Daytime Cold and Flu
- Listing expiration
- 2026-12-31
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 |
|---|---|---|---|---|---|---|
| MUCINEX INSTASOOTHE COUGH | DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | 0d99237c-0b52-0af6-e063-6394a90aba14 | 2026-08-03 | Warnings | M012 |
| daytime nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | 182a105b-bd49-42b5-b4e0-46e5ec0197e3 | 2026-08-03 | Warnings | M012 |
| equaline nighttime cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | United Natural Foods, Inc. dba UNFI | 05e089e7-8772-4bf4-914f-6a26067ee719 | 2026-08-03 | Warnings | M012 |
| Allergy | CHLORPHENIRAMINE MALEATE | Major Pharmaceuticals | 66b918d3-5c37-4889-b981-819ced8b6147 | 2026-08-03 | Warnings | M012 |
| Tukol Max Action Cold and Flu Nighttime Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Genomma Lab USA | cf0987a3-2c1d-4f40-8551-df9a8e08cd3d | 2026-08-03 | Warnings | M012 |
| Pressure, Pain and Mucus | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Meijer Distribution, Inc. | 7d42e164-86e9-4baa-a389-3271cf99920e | 2026-08-03 | Warnings | M012 |
| DG Health Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Dolgencorp Inc | ed754d5c-74e1-4dee-a5c5-10ccec1b81db | 2026-08-03 | Warnings | M012 |
| RIGHT REMEDIES Mucus Relief DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Strive Pharmaceuticals Inc. | 51c4dcfb-8725-d547-e063-6394a90ac04c | 2026-07-31 | Warnings | M012 |
| Stona for Children | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Sato Pharmaceutical Co., Ltd. | 18f3d694-9dff-407e-a264-916dbd201f9a | 2026-07-31 | Warnings | M012 |
| Stonarhini | CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE | Sato Pharmaceutical Co., Ltd. | cc353280-0b4c-418c-93fe-850125955009 | 2026-07-31 | Warnings | M012 |
| cold and flu HBP | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE | Meijer Distribution Inc | 5519e918-71cb-4430-ae57-e03cd5ac6002 | 2026-07-31 | Warnings | M012 |
| Good Neighbor Pharmacy allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Amerisource Bergen | 9819522f-f3db-4cb8-9680-423114ace2f6 | 2026-07-31 | Warnings | M012 |
| Sinus Relief Daytime, Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL | Rite Aid Corporation | 352b89b5-6995-4873-a103-e8f89074fdc9 | 2026-07-30 | Warnings | M012 |
| Severe Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Family Dollar Services Inc | ce590997-3cae-4f22-ac39-2b14d39494bc | 2026-07-30 | Warnings | M012 |
| allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Meijer Distribution Inc | f1e83e43-011c-4470-bd55-fb2818a9fc84 | 2026-07-30 | Warnings | M012 |
| Robitussin Direct Cough | DEXTROMETHORPHAN HYDROBROMIDE | Haleon US Holdings LLC | 70c9556b-063a-4fb3-96f6-1d4ffa495ed4 | 2026-07-30 | Warnings | M012 |
| Major Nasal Decongestant | OXYMETAZOLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | a302e341-1c00-4c3d-b71f-c4c0b307aa67 | 2026-07-29 | Warnings | M012 |
| Pain Reliever PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Walgreens | 4c737cd6-fe56-4cef-887c-cd6cf83b254c | 2026-07-29 | Warnings | M012 |
| ROBITUSSIN LONG-ACTING COUGHGELS | DEXTROMETHORPHAN HYDROBROMIDE | Haleon US Holdings LLC | 472c5c1f-eb5a-444b-a17e-f0d71007fb15 | 2026-07-29 | Warnings | M012 |
| TOPCARE NITE TIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Topco Associates LLC | 905d1c5c-65c8-47a3-ad7a-61a4b4b98f0d | 2026-07-29 | 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 |