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 |
|---|---|---|---|---|---|---|
| Cold and Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Rite Aid Corporation | 1affbef6-dd27-40c2-a5d3-b121aa62496a | 2025-11-15 | Warnings | M012 |
| Cold and Flu Day, Night | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Walgreen Company | b9adfb5d-6576-4ff8-a7d7-a89b867c5292 | 2025-11-14 | Warnings | M012 |
| PECGEN DMX | DEXTROMETHORPHAN HBR, GUAIFENESIN | KRAMER NOVIS | a627824c-5e3d-4672-a047-6c801b50b432 | 2025-11-14 | Warnings | M012 |
| Supress DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | KRAMER NOVIS | 7da0611e-729c-4cf8-88f3-f8877b9f5cfa | 2025-11-14 | Warnings | M012 |
| G-ZYNCOF | DEXTROMETHORPHAN HBR AND GUAIFENESIN | Kramer Novis | c1aa7060-0f32-4ea1-8e2e-1aa131bd55fc | 2025-11-14 | Warnings | M012 |
| Tussi Pres B | DEXTROMETHORPHAN HYDROBROMIDE, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE | KRAMER NOVIS | d0afa44c-3acf-42a5-9889-4e9c10225256 | 2025-11-14 | Warnings | M012 |
| equate vapor ice cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores Inc | b2c0692c-ed0b-4fcf-b88d-59a788b124c6 | 2025-11-14 | Warnings | M012 |
| Guaifenesin 400mg | GUAIFENESIN | Marlex Pharmaceuticals Inc | 13f4db4e-687e-9d7b-e063-6294a90ab088 | 2025-11-13 | Warnings | M012 |
| Guaifenesin 200mg | GUAIFENESIN | Marlex Pharmaceuticals Inc | 13b8f480-d1ac-d70c-e063-6394a90ab4f4 | 2025-11-13 | Warnings | M012 |
| Diphenhydramine HCL | DIPHENHYDRAMINE HCL | PD-Rx Pharmaceuticals, Inc. | c1873a4c-661f-4896-bcc0-f6d3a655de94 | 2025-11-13 | Warnings | M012 |
| Theraflu Severe Cold Relief Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | c24b9489-208c-472b-8ae5-c6e86c12e04d | 2025-11-13 | Warnings | M012 |
| Theraflu Severe Cold Relief Chest Congestion Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN | Haleon US Holdings LLC | 8c821671-dc68-4e27-aa87-b4e45ade9817 | 2025-11-13 | Warnings | M012 |
| Robitussin Maximum Strength Severe Cough Plus Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Haleon US Holdings LLC | 6a6f5da8-6433-4284-8df7-2d5b099b74dc | 2025-11-13 | Warnings | M012 |
| equaline allergy | DIPHENHYDRAMINE HCL | United Natural Foods, Inc. dba UNFI | 8e4eb1eb-5b55-4531-94d2-998425ec80ed | 2025-11-13 | Warnings | M012 |
| Cold and Flu DayTime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Safeway, Inc. | 7a78f24b-7c23-4318-99dc-90c05db185b1 | 2025-11-13 | Warnings | M012 |
| ZYNCOF | DEXTROMETHORPHAN HBR AND GUAIFENESIN | Kramer Novis | cffd6d5f-0cb2-4d38-bdb0-6a21120418cc | 2025-11-13 | Warnings | M012 |
| equate vapor ice cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores Inc | b6da1659-8c79-4cce-a817-907a7f061a2d | 2025-11-13 | Warnings | M012 |
| Tussi Pres | GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE | Kramer Novis | 0d4ee530-2a5c-41a0-88bf-ac92d538661b | 2025-11-12 | Warnings | M012 |
| 4 Way Fast Acting | PHENYLEPHRINE HYDROCHLORIDE | Haleon US Holdings LLC | a8fc41c7-4425-41b8-b1c6-eb22ac054734 | 2025-11-12 | Warnings | M012 |
| Quality Choice Vapor Steam | CAMPHOR (SYNTHETIC) | Chain Drug Marketing Association, Inc. | 1f1e6be5-d407-330c-e063-6294a90a4e80 | 2025-11-12 | 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 |