DAYTIME COLD AND FLU
- Product NDC
- 51316-676
- 11-digit product format
- 513160676
- Labeler code
- 51316
- Product ID
- 51316-676_737aafe1-dd7e-487d-b474-60be1ea33aac
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, dextromethorphan hydrobromide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-06-22
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
- Active strength
- 325; 10 mg/1; mg/1
- 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/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2709673 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 59db2573-7ebb-4cf9-bfe3-428929bb4eeb | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| Effervescent Cold Relief | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHYLEPHRINE BITARTRATE | Topco Associates LLC | a2929bcb-fa81-4f15-b087-a9996b5e7d1f | 2024-11-13 | Warnings | M012 |
| Equate Effervescent Cold Relief | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Walmart | 6271bb48-74b2-eb57-e053-2991aa0afd1b | 2024-11-13 | Warnings | M012 |
| Equaline Effervescent Cold Relief | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | United Natural Foods, Inc. dba UNFI | 6bf341e0-94b1-08ff-e053-2991aa0af634 | 2024-11-13 | Warnings | M012 |
| Good Sense Effervescent Cold Relief | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Good Sense | cd25e250-bb8b-7e83-e053-2a95a90a2639 | 2024-11-13 | Warnings | M012 |
| Top Value Effervescent Cold Relief | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Tower Laboratories Ltd | 440a00b1-7960-0cc4-e054-00144ff8d46c | 2024-11-13 | Warnings | M012 |
| Top Value Effervescent Cold Relief - Orange | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Tower Laboratories Ltd. | c6f207e8-bc0d-853a-e053-2a95a90ac623 | 2024-11-13 | Warnings | M012 |
| Effervescent Orange Cold Relief | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | DOLGENCORP, LLC | 7fad8e65-34fe-5313-e053-2a91aa0a56f4 | 2024-11-13 | Warnings | M012 |
| Dollar General Effervescent Cold Relief | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHYLEPHRINE BITARTRATE | DOLGENCORP, LLC | 7face5c7-f5c7-7eee-e053-2991aa0ab064 | 2024-11-13 | Warnings | M012 |
| Quality Choice Effervescent Cold Relief Plus | ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE | Chain Drug Marketing Association | 90622927-9682-4eb0-8c7f-894230b3dda4 | 2024-11-13 | Warnings | M012 |
| Quality Choice Effervescent Cold Relief - Orange | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Chain Drug Marketing Association | 9f7d76f0-4f1c-a1c7-e053-2a95a90a3dca | 2024-11-13 | Warnings | M012 |
| WinCo Foods Effervescent Cold Relief | ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE | WinCo Foods, LLC | d443a030-d3d6-40e0-8fe0-329de6bc494f | 2024-11-13 | Warnings | M012 |
| careone tussin dm | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | American Sales Company | 954fe703-9a10-4354-8b71-4d98a22a0b9f | 2024-11-13 | Warnings | M012 |
| NASAL DECONGESTANT PE | PHENYLEPHRINE HCL | A-S Medication Solutions | 9d030767-dfd6-48b4-9b17-4e20c23915f3 | 2024-11-13 | Warnings | M012 |
| Childrens SUDAFED PE Cold plus Cough | DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 20e45243-3989-413a-bcf1-49d754ff2e44 | 2024-11-12 | Warnings | M012 |
| Tukol Cough And Cold Honey Flavor | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Genomma Lab USA | a4b333dc-58da-45db-87b6-6fcb8fb542b8 | 2024-11-12 | Warnings | M012 |
| daytime nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Walgreen Company | 4b49137c-8fc9-43b7-b1a1-82e318237eb6 | 2024-11-12 | Warnings | M012 |
| CVS Original Nasal Mist | OXYMETAZOLINE HCL | CVS PHARMACY, INC | e9c551a0-cd78-4272-b42f-36c096d26736 | 2024-11-12 | Warnings | M012 |
| up and up cough plus chest congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | Target Corporation | ed5dfeb1-8f7a-46ff-ae27-3fa5de5b397c | 2024-11-12 | Warnings | M012 |
| DG Health Cold and Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Dolgencorp Inc | b33d104b-0b4d-40c6-8345-c2c740327331 | 2024-11-11 | Warnings | M012 |
| Zephrex D | PSEUDOEPHEDRINE HYDROCHLORIDE | L. Perrigo Company | 5468a7e2-361b-494f-9ca3-1b62f3819f65 | 2024-11-11 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 51316-676-62 | 51316067662 | 12 BLISTER PACK in 1 CARTON (51316-676-62) / 2 TABLET, FILM COATED in 1 BLISTER PACK | 12 blister pack | 2026-06-22 | No | No | Current |