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 |
|---|---|---|---|---|---|---|
| topcare infants pain and fever | ACETAMINOPHEN | Topco Associates LLC | a1145ac3-3e55-4bd5-a53e-6cf869add9a1 | 2024-07-02 | Warnings | 362O9ITL9D |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Proficient Rx LP | 9bad45b7-32ce-47aa-bfdf-8e6a75513056 | 2024-07-01 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Proficient Rx LP | a8f8bb34-6d61-47a8-b58b-0b6763458052 | 2024-07-01 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Cold Terminator Cold Relief | PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Wildman Business Group | e8538d9c-f9ba-40b1-b60f-f57921f39b64 | 2024-07-01 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| Nighttime Severe Honey Cold and Flu | ACETAMINOPHEN, DEXTROMETHROPHAN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | TARGET CORPORATION | 1c02e465-8750-a088-e063-6394a90a8efb | 2024-06-29 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| ACTIDOM DMX | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | ACTIPHARMA, LLC | 0166322e-7dbb-4658-a5c5-1d0525bb7655 | 2024-06-28 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 495W7451VQ |
| ACTINEL DM | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | ACTIPHARMA, LLC | 16660d82-524b-42ca-8581-48237caa13b2 | 2024-06-28 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 495W7451VQ |
| PurgenLabs Acetaminophen | ACTAMINOPHEN | Advanced Rx LLC | 915c4608-af1b-4119-8291-4ce9fd701d76 | 2024-06-28 | Warnings | M012 362O9ITL9D |
| Dextromethorphan Polistirex Extended-Release | DEXTROMETHORPHAN POLISTIREX | Amneal Pharmaceuticals LLC | e0104a59-0bc2-4401-8c14-7f28499dbac6 | 2024-06-27 | Warnings | 9D2RTI9KYH |
| Dextromethorphan Polistirex Extended-Release | DEXTROMETHORPHAN POLISTIREX | Amneal Pharmaceuticals LLC | ce7402d1-e48f-4bf1-90e9-cc57a52b35e5 | 2024-06-27 | Warnings | 9D2RTI9KYH |
| Daytime Ultra Concentrated Cold and Flu | ACETAMINOPHEN, DEXTROMETHROPHAN HBR, PHENYLEPHRINE HCL | TARGET CORPORATION | 1bc90b2f-612c-e977-e063-6294a90a40b4 | 2024-06-26 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| leader childrens pain and fever | ACETAMINOPHEN | Cardinal Health 110, LLC. dba Leader | 4fb4f4b2-c238-4933-b874-08def3b34a28 | 2024-06-26 | Warnings | 362O9ITL9D |
| good neighbor pharmacy pain and fever childrens | ACETAMINOPHEN | Amerisource Bergen | ca0833ef-837b-47dc-8676-e016af96622c | 2024-06-26 | Warnings | 362O9ITL9D |
| leader childrens pain and fever | ACETAMINOPHEN | Cardinal Health 110, LLC. dba Leader | 4a030c3e-8104-4a0a-98c5-6ab469451f20 | 2024-06-26 | Warnings | 362O9ITL9D |
| Childrens Acetaminophen | ACETAMINOPHEN | Padagis Israel Pharmaceuticals Ltd | a426dd82-b2d6-405e-b0af-cfb1310a6e19 | 2024-06-26 | Warnings | 362O9ITL9D |
| Pain Reliever | ACETAMINOPHEN | WALMART INC. (see also Equate) | 7d86a03f-74f4-4b24-b6a6-8747acfe905e | 2024-06-26 | Warnings | 362O9ITL9D |
| Halls Mentholyptus | MENTHOL | Mondelez Global LLC | f5292c5b-5608-4e13-afc2-4f3d7133da88 | 2024-06-25 | Warnings | M012 |
| Halls Strawberry | MENTHOL | Mondelez Global LLC | 75638f29-7f2a-46b0-b8a0-e87bc7d6eba1 | 2024-06-25 | Warnings | M012 |
| Good Sense Nasal Decongestant PE | PHENYLEPHRINE HYDROCHLORIDE | A-S Medication Solutions | 5396a9cf-16eb-4628-9432-f49c67ffe2ce | 2024-06-25 | Warnings | M012 04JA59TNSJ |
| leader childrens pain and fever | ACETAMINOPHEN | Cardinal Health 110, LLC. dba Leader | 5bcc5da9-7e64-4308-a5be-2f47a8ca774d | 2024-06-25 | Warnings | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.