daytime nighttime severe cold and flu
- Product NDC
- 51316-474
- 11-digit product format
- 513160474
- Labeler code
- 51316
- Product ID
- 51316-474_b186a087-530c-41f5-9c61-d9f60370235e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, dextromethorphan HBr, doxylamine succinate, guaifenesin, phenylephrine HCl
- Dosage form
- KIT
- Labeler
- CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-08-20
- 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 nighttime severe cold and flu
- Listing expiration
- 2027-12-31
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 |
|---|---|---|---|---|---|---|
| Cough Drops | MENTHOL | United Natural Foods, Inc. | f9f0d020-e031-245e-e053-6294a90addb5 | 2024-10-08 | Warnings | M012 |
| Cough Drops | MENTHOL | United Natural Foods, Inc. | fb7ee463-8003-a306-e053-6294a90a8259 | 2024-10-08 | Warnings | M012 |
| Cough Drops | MENTHOL | United Natural Foods, Inc. | fb7e4a84-d2c2-65e5-e053-6394a90a0c72 | 2024-10-08 | Warnings | M012 |
| Cough Drops | CHERRY | United Natural Foods, Inc. | f9f0e853-6997-a49b-e053-6294a90aa4b8 | 2024-10-08 | Warnings | M012 |
| Cough Drops | MENTHOL | United Natural Foods, Inc. | fb7fa728-911d-aaf0-e053-6394a90ace31 | 2024-10-08 | Warnings | M012 |
| Cough Drops | MENTHOL | United Natural Foods, Inc. | fb7f3b84-1e61-eadf-e053-6394a90a9e5c | 2024-10-08 | Warnings | M012 |
| Cough Drops | MENTHOL | United Natural Foods, Inc. | fb7f515f-7302-d153-e053-6394a90a0834 | 2024-10-08 | Warnings | M012 |
| Rompe Pecho NT NT | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Efficient Laboratories Inc | 06faafaa-50a6-c16e-e063-6294a90a49cb | 2024-10-08 | Warnings | M012 |
| Mucus Relief Cough and Congestion DM | GUAIFENESIN AND DEXTROMETHORPHAN HBR | Bryant Ranch Prepack | 8c25285e-e2cd-4e10-af63-5dce8098b615 | 2024-10-08 | Warnings | M012 |
| Severe Throat Sore Drops | MENTHOL | Target Corporation Inc. | 949543d5-5043-ac06-e053-2995a90ab398 | 2024-10-07 | Warnings | M012 |
| Natural Herbal Cough Drops | COUGH DROPS | Target Corporation Inc. | a23ddfa9-19e0-99ee-e053-2a95a90a6856 | 2024-10-07 | Warnings | M012 |
| Cough Drops | SIMPLY MENTHOL COUGH DROPS | Perrigo Direct, Inc. | fb809c63-94f1-bb7a-e053-6294a90a0a39 | 2024-10-07 | Warnings | M012 |
| Cough Drops | SIMPLY CHERRY COUGH DROPS | Perrigo Direct, Inc. | fb808dc5-bf63-836c-e053-6294a90a80aa | 2024-10-07 | Warnings | M012 |
| Cough Drops | SIMPLY HONEY LEMON | Perrigo Direct Inc. | fb898616-d604-b4c3-e053-6294a90a23bf | 2024-10-07 | Warnings | M012 |
| Natural Herb Cough Drops | MENTHOL HERB | CVS Pharmacy | fcd16063-abca-49a0-e053-6294a90acb26 | 2024-10-07 | Warnings | M012 |
| Lemon Mint Herb Throat Drops | SUGAR FREE LEMON MINT HERB | CVS Pharmacy | fce6b5fa-846d-9911-e053-6294a90afc9b | 2024-10-07 | Warnings | M012 |
| Sugar Free Cough Drops | MENTHOL | CVS Pharmacy | fcd053e9-92ef-70ba-e053-6294a90aa4dd | 2024-10-07 | Warnings | M012 |
| Sugar Free Cough Drops | HONEY LEMON | CVS Pharmacy | f074a64d-dc01-1a37-e053-2995a90adc49 | 2024-10-07 | Warnings | M012 |
| Cough Drops | HONEY LEMON | CVS Pharmacy | f075010d-a07a-5e9d-e053-2995a90a3ca3 | 2024-10-07 | Warnings | M012 |
| Sugar Free Cough Drops | HONEY LEMON | CVS Pharmacy | fcd053e9-92ee-70ba-e053-6294a90aa4dd | 2024-10-07 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 51316-474-02 | 51316047402 | 1 KIT in 1 CARTON (51316-474-02) * 355 mL in 1 BOTTLE (51316-415-40) * 355 mL in 1 BOTTLE (51316-681-40) | 1 kit | 2026-08-20 | No | No | Current |