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 |
|---|---|---|---|---|---|---|
| Target Dye Free Childrens Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Target Corporation | 76299495-7259-4bbe-8393-7eabfe22715a | 2025-11-05 | Warnings | M012 |
| TARGET CHILDRENS DT AND NT COLD and COUGH | BROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,PHENYLEPHRINE HCL,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | TARGET CORPORATION | 05ac2a40-5eee-4013-b55b-6e370a28b21c | 2025-11-05 | Warnings | M012 |
| TARGET CHILDRENs COLD and COUGH | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | TARGET CORPORATION | eb912834-1b14-484d-90f7-a8deb52c0d4e | 2025-11-05 | Warnings | M012 |
| UP and UP Daytime Childrens Multi Symptom Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Target Corporation | a2d99bc8-7295-4922-acff-0cb02c91273c | 2025-11-05 | Warnings | M012 |
| Good Neighbor Pharmacy Medicated Chest Rub | CAMPHOR, MENTHOL, EUCALYPTUS OIL | AMERISOURCE BERGEN | c1843f1a-ae5b-0fdf-e053-2995a90aae38 | 2025-11-05 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL | QUALITY CHOICE (Chain Drug Marketing Association) | 4754363d-e163-42e0-a65d-1c4bac24f6c9 | 2025-11-05 | Warnings | M012 |
| Day Time Cold and Flu | ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL | Safeway, Inc. | 76d62892-615d-4744-95aa-3be1207a0e57 | 2025-11-05 | Warnings | M012 |
| Tussin DM Cough and Chest Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | Safeway, Inc. | 6fefff08-13b0-47eb-aa32-8d7e4deeae7b | 2025-11-05 | Warnings | M012 |
| Menthol Drops Freegells Extra Strong Eucalyptus 30ct | MENTHOL | R.L. ALBERT & SON, INC | 165a8efa-2b03-4329-99fa-3233f0af7d08 | 2025-11-04 | Warnings | M012 |
| Menthol Drops Freegells Extra Strong Honey Lemon 30ct | MENTHOL | R.L. ALBERT & SON, INC | f9ea46fc-0b04-444e-95fc-09aff7e7978a | 2025-11-04 | Warnings | M012 |
| QUALITY CHOICE Maximum Strength Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Chain Drug Marketing Association, Inc. | 40413cdb-68ac-70e1-e063-6394a90a9217 | 2025-11-04 | Warnings | M012 |
| Tussin CF | DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCL | WinCo Foods, LLC | 73fec783-1594-447b-b059-49ea9dbb5bee | 2025-11-04 | Warnings | M012 |
| Texaclear Fast Acting Allergy Relief | CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE | GM Pharmaceuticals, INC | 17a2f643-fa98-21ee-e054-00144ff88e88 | 2025-11-03 | Warnings | M012 |
| Cold plus Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HYVEE INC | 3e618bc7-0f51-e586-e063-6294a90afe37 | 2025-11-03 | Warnings | M012 |
| Head Congestion plus Mucus PE | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HYVEE INC | 3e61b5b3-ad15-01bf-e063-6394a90a6ec3 | 2025-11-03 | Warnings | M012 |
| Cold plus Head Congestion Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HYVEE INC | 409540c0-1bab-9969-e063-6394a90a47c1 | 2025-11-03 | Warnings | M012 |
| Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HYVEE INC | 3e60b340-bd60-9318-e063-6294a90ad079 | 2025-11-03 | Warnings | M012 |
| Sinus Pressure and Pain PE | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | HYVEE INC | 3e60e32f-3e5f-b775-e063-6294a90a097d | 2025-11-03 | Warnings | M012 |
| Sinus and Headache | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | HYVEE INC | 3e614265-b35a-5d01-e063-6294a90aad85 | 2025-11-03 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | HYVEE INC | 3e60b0ed-889d-0f17-e063-6394a90a4694 | 2025-11-03 | 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 |