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 |
|---|---|---|---|---|---|---|
| Excedrin Extra Strength Pain Reliever | ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE | Haleon US Holdings LLC | 0faa3592-4d56-4645-9a0e-066e0bdfebb6 | 2024-04-05 | Warnings | 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN TABLET EXTENDED RELEASE | Bryant Ranch Prepack | 61ea1796-b9c7-4cb9-9a36-60943f884875 | 2024-04-05 | Warnings | 362O9ITL9D |
| Butalbital, Acetaminophen, Caffeine and Codeine Phosphate | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | Bryant Ranch Prepack | 215e2a6f-ec32-4836-8fad-22c8b40ba1f1 | 2024-04-04 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Pain Relief Childrens Dye Free | ACETAMINOPHEN | H E B | 3f9beeeb-5e27-4b81-a647-20e65f0e9fc9 | 2024-04-03 | Warnings | 362O9ITL9D |
| Leader Nasal Decongestant | OXYMETAZOLINE HYDROCHLORIDE | Cardinal Health 110,Inc | 98bf8e84-b555-4b5a-90a0-7837a5560289 | 2024-04-03 | Warnings | M012 |
| Butalbital, Acetaminophen and Caffeine | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Bryant Ranch Prepack | e9dffed5-d615-4e63-9860-c0f6f23848a1 | 2024-04-03 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Childrens Pain Relief | ACETAMINOPHEN | H E B | a0c0277e-50aa-4328-8f93-ab20c6176b2b | 2024-04-03 | Warnings | 362O9ITL9D |
| ANTICOAGULANT SODIUM CITRATE | TRISODIUM CITRATE DIHYDRATE | Baxter Healthcare Corporation | 7025a0f9-1a56-4416-a3a4-925d755aed90 | 2024-04-02 | B22547B95K | |
| Eye Wash | WATER | M-star (Hubei) Health&Care Products Co., Ltd. | 71706039-e250-4f08-9687-71b2928c4e46 | 2024-04-01 | Warnings | 059QF0KO0R |
| DAYTIME COLD AND FLU RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Advanced Rx LLC | 38299cf3-e884-4676-8cc4-6dd64e7d023c | 2024-03-30 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| NIGHTTIME COLD AND FLU RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Advanced Rx LLC | d1542362-19c5-4470-89e8-87d26e2ca8ed | 2024-03-30 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| Mucus DM | GUAIFENESIN AND DEXTROMETHORPHAN HBR | Amerisource Bergen | bf4bcec8-7136-4ae7-a459-a30ee881b98d | 2024-03-29 | Warnings | 9D2RTI9KYH 495W7451VQ |
| Dual Action Pain Relief | DUAL ACTION PAIN RELIEF | Allegiant Health | fb4fc347-0f90-429f-9ca8-903e736f5496 | 2024-03-29 | Warnings | 362O9ITL9D |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | c8d65aab-d6ae-bc69-e053-2a95a90a7b5e | 2024-03-27 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| ANTIGRIP Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Pharmadel LLC | 12de30fd-95b6-f16d-e063-6294a90aeba2 | 2024-03-27 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Family Dollar (FAMILY WELLNESS) | 0044c53c-11dd-41a9-a5d9-622dd8b1c144 | 2024-03-27 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Family Dollar (FAMILY WELLNESS) | 650cb15e-c448-4df3-b0f8-4398be05d841 | 2024-03-27 | Warnings | 362O9ITL9D |
| Envirotox | TRITICUM AESTIVUM, BERBERIS VULGARIS, LAPPA MAJOR, RHAMNUS PURSHIANA, SENNS (CASSIA ANGUSTIFOLIA), PHYTOLACCA DECANDRA, GLYCYRRHIZA GLABRA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, ACETONUM ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM. | BioActive Nutritional, Inc. | 2b5cfdba-cf4d-4eb0-8c60-20eac6922663 | 2024-03-26 | Warnings | 6DC9Q167V3 |
| rugby infants acetaminophen | ACETAMINOPHEN | Rugby Laboratories | 8aa9ac68-ca61-4163-a876-52034138c1ea | 2024-03-25 | Warnings | 362O9ITL9D |
| ULINE Eyewash | EYEWASH | Uline. | 14545fc9-1fb4-befa-e063-6294a90a0474 | 2024-03-23 | Warnings | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.