NDC 51316-004 - Severe Congestion, Cough, Cold and Flu Relief Maximum Strength, Nighttime
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 51316-004
- Package NDCs from labels
- 51316-004-45
- Manufacturer
- CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | LNK International, Inc.
- Effective date
- 2025-10-17
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| CVS 44-004063 | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | LNK International, Inc. | 2025-10-17 | HUMAN OTC DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51316-004-45 | Severe Congestion, Cough, Cold and Flu ReliefMaximum Strength, Nighttime | 177 mL in 1 BOTTLE, PLASTIC | SOLUTION | 177 mL | 400 mg in 20mL | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51316-004 | SEVERE CONGESTION, COUGH, COLD AND FLU RELIEF MAXIMUM STRENGTH, NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL) KIT [CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED] | 4 | Unmatched | 20241017_92c570ff-139f-49ff-a7bd-8a540ecc07c7.zip |
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 |
|---|---|---|---|---|---|---|
| Sinus Pressure and Pain Maximum Strength | ACETAMINOPHEN, PHENYLEPHRINE HCL | Cardinal Health 110, LLC. DBA Leader | 80d25e23-b108-4eb1-88c7-73fe9da8f942 | 2026-04-09 | Warnings | M012 04JA59TNSJ 362O9ITL9D |
| Sore Throat | PHENOL GLYCERIN | Walgreens | 1e845299-178e-49ce-9d08-7e9d548a5a6d | 2026-04-09 | Warnings | PDC6A3C0OX |
| Pain Reliever Childrens | ACETAMINOPHEN | H E B | 7e43de11-d20b-4920-a04d-3c1b5d35e005 | 2026-04-09 | Warnings | 362O9ITL9D |
| mucus d | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | Kroger Company | 5065f07d-2130-4c84-a64a-dc27ef9cb92e | 2026-04-09 | Warnings | 495W7451VQ |
| Mucus Relief DM Cough | DEXTROMETHORPHAN HBR AND GUAIFENESIN | L.N.K. International, Inc. | 2fea3533-8218-4875-affe-5b33a22c553a | 2026-04-08 | Warnings | M012 9D2RTI9KYH 495W7451VQ |
| Tylenol Cold Plus Flu Plus Chest Congestion | ACETAMINOPHEN, GUAIFENESIN | Kenvue Brands LLC | 4e60e1ad-4ad4-c329-e063-6294a90ab318 | 2026-04-08 | Warnings | M012 362O9ITL9D 495W7451VQ |
| Dr. Simi Mucus Relief | GUAIFENESIN | Farmacias De Similares TX LLC | 4ef7dae3-9081-bc3b-e063-6294a90a9a75 | 2026-04-08 | Warnings | 495W7451VQ |
| Mucinex Fast-Max Severe Congestion and Cough and Mucinex Nightshift Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 4592d547-556f-4eec-8faf-6ff9a92e46c8 | 2026-04-08 | Warnings | M012 2390630 1043543 2173667 |
| Goodmeds Allergy Relief Diphenhydramine HCl | DIPHENHYDRAMINE HYDROCHLORIDE | Cabinet Health P.B.C. | e24121d2-c9d2-4bbd-869e-eeed7e2bb881 | 2026-04-08 | Warnings | M012 |
| Excedrin Extra Strength Pain Reliever | ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE | Navajo Manufacturing Company Inc. | f7e572e9-82a7-2127-e053-6394a90ab01a | 2026-04-08 | Warnings | 362O9ITL9D |
| Midol | ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE | Navajo Manufacturing Company Inc. | cabd10f2-a91e-4406-9249-915e306c867b | 2026-04-08 | Warnings | 362O9ITL9D |
| Excedrin Migraine | ACETAMINOPHEN, ASPIRIN, AND CAFFEINE | Navajo Manufacturing Company Inc. | 4efbd21b-92fe-96a7-e063-6294a90ac4ad | 2026-04-08 | Warnings | 362O9ITL9D |
| Nasal Decongestant PE Maximum Strength | PHENYLEPHRINE HCL | Strategic Sourcing Services LLC | 8460d4f9-8d7b-4ae4-8047-c2010d9c8013 | 2026-04-08 | Warnings | M012 04JA59TNSJ |
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | Cardinal Health 110, LLC. DBA Leader | d2dab450-cf82-4be2-a4e2-630295fb59ab | 2026-04-08 | Warnings | M012 |
| Nighttime Cough | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Walgreens | 4657c02b-887b-4746-8a78-83a72465e07b | 2026-04-08 | Warnings | M012 9D2RTI9KYH |
| Menstrual Pain Relief Maximum Strength / Multi Symptom | ACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATE | DOLGENCORP, LLC | d441088b-fb1d-4fdc-954f-032f3122212f | 2026-04-08 | Warnings | 362O9ITL9D |
| Leader Cough DM | DEXTROMETHORPHAN POLISTIREX | Cardinal Health 110, LLC. dba Leader | a07b70d0-3842-4ea6-abb4-95b4638d5e55 | 2026-04-08 | Warnings | 9D2RTI9KYH |
| Leader Mucus Relief | GUAIFENESIN | Cardinal Health 110, LLC. dba Leader | ca735722-0baa-4c85-8311-17dbce915fc5 | 2026-04-08 | Warnings | 495W7451VQ |
| MIGRAINE FORMULA | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Meijer, Inc. | 529b6ee6-043c-430a-b2e1-b63c81f10291 | 2026-04-08 | Warnings | 362O9ITL9D |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 092f4694-98df-41bd-b37c-afbcda087e56 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.