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 |
|---|---|---|---|---|---|---|
| SODIUM PHENYLACETATE and SODIUM BENZOATE | SODIUM PHENYLACETATE AND SODIUM BENZOATE | Omnivium Pharmaceuticals LLC | 8fafc39b-69db-40f3-8a09-ee859e8cef19 | 2025-05-15 | Warnings, Adverse reactions | OJ245FE5EU |
| BACTIMICINA CHILDRENS ALLERGY | DIPHENHYDRAMINE HYDROCHLORIDE | DLC Laboratories, Inc. | eaf554d4-a758-4ed6-bec5-d6cbfedae408 | 2025-05-15 | Warnings | M012 |
| Bactimicina Childrens Cough and Cold | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | DLC Laboratories, Inc. | d407a583-07ae-4d47-b15a-24b5865c82da | 2025-05-15 | Warnings | M012 9D2RTI9KYH |
| Acetaminophen and Ibuprofen | ACETAMINOPHEN AND IBUPROFEN | AMERISOURCE BERGEN | 04dc36e8-4d51-aabe-e063-6294a90a0d53 | 2025-05-15 | Warnings | 362O9ITL9D |
| Acetaminophen and Ibuprofen | ACETAMINOPHEN AND IBUPROFEN | AMERISOURCE BERGEN | 353136b4-884d-baa2-e063-6394a90a89e9 | 2025-05-15 | Warnings | 362O9ITL9D |
| Numb520 | LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE | Clinical Resolution Laboratory, Inc. | 65d3b614-361d-4fb9-9583-a95be754bc82 | 2025-05-15 | Warnings | 04JA59TNSJ |
| Mucinex Nightshift Sinus Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDE | RB Health (US) LLC | 35322238-d498-1a52-e063-6394a90ac9c4 | 2025-05-15 | Warnings | M012 YAN7R5L890 9D2RTI9KYH 362O9ITL9D |
| Theraflu Flu Relief Max Strength Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | a1405038-80f2-45e5-bd8c-8c6b0ee348be | 2025-05-15 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| Cyclomydril | CYCLOPENTOLATE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE | Alcon Laboratories, Inc. | 8268b70f-3f10-48dd-bb24-baaeb27a1325 | 2025-05-15 | Warnings, Adverse reactions | 04JA59TNSJ |
| Phenylephrine Hydrochloride | PHENYLEPHRINE HYDROCHLORIDE | Fresenius Kabi USA, LLC | 1e77b9c8-fa17-4aa4-adc8-ff716ab2e5d7 | 2025-05-15 | Warnings, Adverse reactions | 04JA59TNSJ |
| Eyesaline Emergency Eyewash | STERILE EYESALINE EYEWASH | Honeywell Safety Products USA, Inc. | 2d567518-4c54-7448-e063-6294a90a3e64 | 2025-05-14 | Warnings | 059QF0KO0R |
| Cold Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | b919f0fe-fae0-4bd8-9ccd-d7569b2a7070 | 2025-05-13 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| Childrens Robitussin Honey Nighttime Cough DM | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Haleon US Holdings LLC | 6afaf85b-bf0c-4c99-acf3-a34f06be20f1 | 2025-05-13 | Warnings | M012 9D2RTI9KYH |
| Robitussin Honey Severe Cough, Flu Plus Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | 77be57fb-0ae5-4fad-97f3-b6a4b57383a9 | 2025-05-13 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| good neighbor pharmacy childrens pain and fever | ACETAMINOPHEN | Amerisource Bergen | 268a789b-8f31-4739-9777-523249cac326 | 2025-05-13 | Warnings | 362O9ITL9D |
| Topcare 8 Hour Pain Relief | ACETAMINOPHEN | Topco Associates LLC | 38abe710-3d8a-41b0-b057-38c5dfd53322 | 2025-05-13 | Warnings | 362O9ITL9D |
| cough dm | DEXTROMETHORPHAN POLISTIREX | ATLANTIC BIOLOGICALS CORP. | 73aede9d-37dd-4aa5-a906-0e0c94cecff1 | 2025-05-12 | Warnings | 9D2RTI9KYH |
| Allergy | CHLORPHENIRAMINE MALEATE | Bryant Ranch Prepack | c948e612-a491-4ad0-adb9-cf31ef76e4d8 | 2025-05-12 | Warnings | M012 |
| Arthritis Pain Relief | ACETAMINOPHEN | KROGER COMPANY | 0fec22a3-aad0-8c28-e063-6394a90adc18 | 2025-05-10 | Warnings | 362O9ITL9D |
| Maximum Strength Nighttime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Prodose, Inc. | c3d0b70f-d213-4e38-88ab-1c89d93a391d | 2025-05-10 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.