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 |
|---|---|---|---|---|---|---|
| ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Haleon US Holdings LLC | f1d022dd-c2ca-497f-87d5-9ef3e20e8ea7 | 2025-10-30 | Warnings | M012 9D2RTI9KYH 495W7451VQ |
| Extra Strength Acetaminophen | ACETAMINOPHEN | NuCare Pharmaceuticals, Inc. | 41affa1a-5aac-7fc0-e063-6394a90a5557 | 2025-10-30 | Warnings | 362O9ITL9D |
| Endal | TRIPROLIDINE HCL, DEXTROMETHORPHAN HBR | Poly Pharmaceuticals, Inc. | fc5401e2-ed65-72e7-e053-6294a90a81f3 | 2025-10-30 | Warnings | M012 YAN7R5L890 9D2RTI9KYH |
| Mucus Relief DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | Family Dollar (FAMILY WELLNESS) | ebc1a915-f643-4878-9d7a-67a9c6a26b20 | 2025-10-30 | Warnings | 9D2RTI9KYH 495W7451VQ |
| daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Publix Super Markets Inc | c7cef266-46fc-49ab-a2e7-54fc56298659 | 2025-10-30 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| Guaifenesin and Dextromethorphan HBr | GUAIFENESIN AND DEXTROMETHORPHAN HBR | Target Corporation | 15434143-ab8e-4cf9-e063-6394a90a2388 | 2025-10-30 | Warnings | 9D2RTI9KYH 495W7451VQ |
| Sorbitol-Mannitol | SORBITOL AND MANNITOL | ICU Medical Inc. | 5b44e248-4b7b-4777-954a-921c7b309944 | 2025-10-30 | Warnings, Adverse reactions | 506T60A25R |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | SAM'S WEST INC | 16592ad7-b7cb-0837-e063-6394a90ae059 | 2025-10-29 | Warnings | M012 |
| Maximum Strength Severe Congestion and Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN, AND PHENYLEPHRINE HCL | SAFEWAY | 013b94a1-26c7-4371-981a-d1b9d7fd1c98 | 2025-10-29 | Warnings | M012 1043543 9D2RTI9KYH 04JA59TNSJ 495W7451VQ |
| Better Living | PHENYLEPHRINE HYDROCHLORIDE | BETTER LIVING BRANDS LLC | aea0db7f-e01a-4d8e-9c20-4a5ef4a905d1 | 2025-10-29 | Warnings | M012 04JA59TNSJ |
| Glycerin | GLYCERIN | Chain Drug Marketing Association Inc. | 424d91f0-ecf9-6d9b-e063-6394a90a8006 | 2025-10-29 | Warnings | PDC6A3C0OX |
| MAPAP Extra Strength | ACETAMINOPHEN | Major Pharmaceuticals | 34a95450-3f04-4de4-9113-73e7bd5724a0 | 2025-10-29 | Warnings | 362O9ITL9D |
| AXIM DayTime - Night Time 72 Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | VIVUNT PHARMA LLC | de9eb2d5-ba51-4637-e053-2995a90a0451 | 2025-10-29 | Warnings | M012 |
| Dollar General Vapor Steam | CAMPHOR (SYNTHETIC) | DOLGENCORP, LLC | 86d0f3ac-1359-c2f9-e053-2a91aa0a35d0 | 2025-10-29 | Warnings | M012 |
| hemorrhoidal | GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM | Publix Super Markets Inc | 354a640c-bc7e-45c8-9df0-8b5b01767f5c | 2025-10-29 | Warnings | PDC6A3C0OX 04JA59TNSJ |
| GOODNOW PAIN RELIEF | ACETAMINOPHEN | Gobrands, Inc | 4d4a78a5-5a88-4f24-b685-c7c6bb5e989e | 2025-10-29 | Warnings | 362O9ITL9D |
| Sterile Water | WATER | ICU Medical Inc. | 1c0bbcb7-5ed6-4ee7-b297-080d3359474e | 2025-10-29 | Boxed warning, Warnings, Adverse reactions | 059QF0KO0R |
| Allergy Relief | DIPHENHYDRAMINE HCL | Strategic Sourcing Services LLC | 5d628b09-c257-4369-8ddb-47554d83c0d8 | 2025-10-29 | Warnings | M012 |
| Mucus Relief DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | Family Dollar (FAMILY WELLNESS) | b60d1cc6-086c-4483-a101-c5f8d6000969 | 2025-10-29 | Warnings | 9D2RTI9KYH 495W7451VQ |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Amneal Pharmaceuticals of New York LLC | e0cefc7b-e81c-4e15-89a0-fe71dc94338b | 2025-10-28 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.