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 |
|---|---|---|---|---|---|---|
| SIMPEX Guaifenesin | GUAIFENESIN | Simpex Pharma Pvt. Ltd | 1594f9d6-0c48-42bf-b76b-d621f215179a | 2023-11-29 | Warnings | M012 |
| Stona | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Sato Pharmaceutical Co., Ltd. | 8b89f50d-88f8-4773-92ea-5ada61766056 | 2023-11-28 | Warnings | M012 |
| Stona | DEXTROMETHORPHAN HYDROBROMIDE | Sato Pharmaceutical Co., Ltd. | 1ccc9e56-32a4-450f-8412-5814b6aef285 | 2023-11-28 | Warnings | M012 |
| Neo-Synephrine Maximum | PHENYLEPHRINE HYDROCHLORIDE | BF ASCHER AND CO INC | ab8682a4-1f66-6709-e053-2995a90a8b4a | 2023-11-16 | Warnings | M012 |
| Neo-Synephrine Regular | PHENYLEPHRINE HYDROCHLORIDE | BF ASCHER AND CO INC | ab860c10-b8cf-3f92-e053-2a95a90a7317 | 2023-11-16 | Warnings | M012 |
| Neo-Synephrine Mild | PHENYLEPHRINE HYDROCHLORIDE | BF ASCHER AND CO INC | 9b8e9162-e4da-14d9-e053-2995a90a2269 | 2023-11-16 | Warnings | M012 |
| Universal Vaporizing Chest Rub | MENTHOL AND CAMPHOR AND EUCALYPTUS | Universal Distribution Center LLC | b1d25572-da21-408d-aab3-3a0741dfff12 | 2023-11-16 | Warnings | M012 |
| Daytime Cold and Flu Severe, Caseys 4goog | ACETAMINOPHEN, PHENYLEPHRINE, DEXTROMETHORPHAN HBR, GUAIFENESIN TABLET, FILM COATED | Lil' Drug Store Products, Inc. | 0334259d-587e-b2d5-e063-6394a90a3e56 | 2023-11-14 | Warnings | M012 |
| Stona Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Sato Pharmaceutical Co., Ltd. | 0b638db4-5ed3-4665-abcd-f95e677adbd8 | 2023-11-12 | Warnings | M012 |
| Tylenol Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Jones Healthcare Group - Packaging Services, Inc | 6c90b415-4c5f-49e5-beb6-4cf225797b21 | 2023-11-06 | Warnings | M012 |
| Tylenol Cold Plus Flu Severe Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Jones Healthcare Group - Packaging Services, Inc | 8b8582c0-8aef-482f-9738-2f1d4e325d64 | 2023-11-06 | Warnings | M012 |
| Cold and Flu Severe Daytime/Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | Topco Associates LLC | 27ade5f8-2003-4dc6-9244-42676791e1f8 | 2023-11-06 | Warnings | M012 |
| Benadryl Allergy Ultratab | DIPHENHYDRAMINE HYDROCHLORIDE | Jones Healthcare Group - Packaging Services, Inc | ec2070df-8a8a-4cd1-8830-62655433fb3b | 2023-11-05 | Warnings | M012 |
| Daytime Nighttime Ultra Concentrated Cold and Flu | DAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE | TARGET CORPORATION | 093eed84-79b1-7914-e063-6394a90a37af | 2023-11-03 | Warnings | M012 |
| Cough Drops | MENTHOL | Topco Associates LLC | eff68377-2273-6c6c-e053-2995a90a36b2 | 2023-11-03 | Warnings | M012 |
| Sugar Free Cough Drops | MENTHOL | Topco Associates LLC | 096bbcaa-fce1-0fc2-e063-6294a90ad597 | 2023-11-03 | Warnings | M012 |
| TopCare Nite Time SEVERE Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | adc8edf5-ebbe-4d94-9018-aa0dbe118112 | 2023-11-03 | Warnings | M012 |
| MUCOSA | GUAIFENESIN | TIME CAP LABORATORIES,INC | d34ef2e8-adc2-48e5-a572-e354937daec6 | 2023-11-02 | Warnings | M012 |
| Daytime Severe and Nighttime Severe cold and flu | DAYTIME SEVERE - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN AND NIGHTTIME SEVERE-ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | TARGET CORPORATION | 09286d15-b63f-a9de-e063-6294a90ab948 | 2023-11-02 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | AMERIFOODS TRADING COMPANY | f6cece6c-23e4-7811-e053-6394a90a106a | 2023-11-02 | 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 |