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 |
|---|---|---|---|---|---|---|
| Up and Up Hemorrhoid MAX STRENGTH | 14.4% GLYCERIN, 0.25% PHENYLEPHRINE HCL, 1% PRAMOXINE HCL, 15% PETROLATUM | Target Corporation | 867677b5-fd1d-449e-966e-1de0b5c98afb | 2024-08-08 | Warnings | PDC6A3C0OX 04JA59TNSJ |
| ENDOCET | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | 3b8ef94a-da42-46b5-9fa9-2fac9ed6e7c3 | 2024-08-08 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| WesTussin DM NF | WESTUSSIN DM NF | Westminster Pharmaceuticals, LLC | 4e0f9f97-a31c-41ac-9d6c-d81efd20fcef | 2024-08-08 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 025eb0f7-d002-4ce0-87b8-71461ab18356 | 2024-08-08 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Mucus Relief Sinus Severe Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 2f2a2864-af11-4240-bdad-a54aca58d01b | 2024-08-07 | Warnings | M012 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| Cold plus Flu Congestion Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 0199aea2-a9c1-4c9d-8786-28b9dadc832e | 2024-08-07 | Warnings | M012 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| Mucus Relief Cold Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 32d1ce6e-2617-4b50-a9e6-2e1941465dff | 2024-08-07 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 07362db5-a372-4463-af8b-06e8783ca865 | 2024-08-07 | Warnings | M012 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| Head Congestion plus Flu Severe PE | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 1fb11d90-48bf-4baa-9b3a-5d64d81e3a06 | 2024-08-07 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| Mucus Relief Sinus Pressure Pain and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 574774b2-9813-4799-9cd4-27e296dd8584 | 2024-08-07 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| Cold Max Day and NIght | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | a92bcefb-ba29-4b3f-a60b-b4476ca8cf04 | 2024-08-07 | Warnings | M012 |
| Sinus plus Headache | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 778f1f5a-fd04-456f-90d0-998b93e774a5 | 2024-08-07 | Warnings | M012 04JA59TNSJ 362O9ITL9D |
| Head Congestion plus Mucus PE | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 990f3232-bc75-45cf-8a50-cd7861d83f98 | 2024-08-07 | Warnings | M012 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| Mucus Relief Cold and Flu All in One | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 0f5f25c6-7389-4285-b8d5-463cb7b6fcc4 | 2024-08-07 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| Mucus Relief | GUAIFENESIN | CHAIN DRUG MARKETING ASSOCIATION, INC. | 1445433b-69bc-487c-aa5a-e4ac7f5bef21 | 2024-08-07 | Warnings | 495W7451VQ |
| CareOne Infants Acetaminophen | ACETAMINOPHEN | American Sales Company | eacee273-abd7-4ea4-bcaa-7f74abcc9feb | 2024-08-07 | Warnings | 362O9ITL9D |
| Butalbital, Acetaminophen, and Caffeine | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE | Lannett Company, Inc. | 42594152-563e-4984-9901-d6ef3b8a6941 | 2024-08-05 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Nighttime Cold and Flu | ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE | Care One (Retail Business Services, LLC.) | a9a5b39d-b4c8-414e-8fe7-4c0601f75197 | 2024-08-05 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| Diphenhydramine HCl | DIPHENHYDRAMINE HYDROCHLORIDE | American Health Packaging | b94feeb6-f33f-410d-a9b0-776b1ccf34a9 | 2024-08-04 | Warnings | M012 |
| Diphenhydramine HCl | DIPHENHYDRAMINE HYDROCHLORIDE | American Health Packaging | 4cd8aee3-5522-434b-a1b1-9591bed3e9a6 | 2024-08-04 | Warnings | M012 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.