NDC 51316-063 - 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
- 51316-063
- Package NDCs from labels
- 51316-063-45
- 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 |
|---|---|---|---|---|---|---|
| 51316-063-45 | Severe Congestion, Cough, Cold and Flu ReliefMaximum Strength, Nighttime | 177 mL in 1 BOTTLE, PLASTIC | SOLUTION | 177 mL | 650 mg in 20mL | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51316-063 | 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 |
|---|---|---|---|---|---|---|
| Exchange Select Mucus DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Army & Air Force Exchange Service | 99a11bea-8cf5-4c5d-95b1-eaedccaf9e7d | 2026-07-28 | Warnings | 9D2RTI9KYH 495W7451VQ |
| Benadryl | DIPHENHYDRAMINE HYDROCHLORIDE | Kenvue Brands LLC | 702f9786-7ce9-43e4-921d-e1db09612127 | 2026-07-28 | Warnings | M012 |
| oxycodone and acetaminophen | OXYCODONE AND ACETAMINOPHEN | FH2 Pharma LLC | 88d97caf-bcf5-3cde-e053-2995a90acf4a | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| DECONIMO Reconstitution | DECONIMO RECONSTITUTION | Image Amazon LLC | 57ab9b1c-9a18-3786-e063-6394a90a2c63 | 2026-07-28 | Warnings | 059QF0KO0R |
| Prolate | OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN | Forte Bio-Pharma LLC | 9d75ad3b-bc9b-0c22-e053-2a95a90ac71e | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Hikma Pharmaceuticals USA Inc. | 995a6cc7-8b72-4d35-b3b4-8c5752438fb7 | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| LoHist-D | CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL | Larken Laboratories, Inc. | efaa354e-c25c-405b-9d30-001c2796978c | 2026-07-28 | Warnings | M012 |
| NIGHTTIME SEVERE COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | d1115a55-35cd-4f20-8872-f42983a5ebcd | 2026-07-28 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| Childrens Pain and Fever | ACETAMINOPHEN | Aurohealth LLC | f818996c-36d2-4d3d-af3e-39949157edb9 | 2026-07-28 | Warnings | 362O9ITL9D |
| TUSSIN | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Safeway | a5e2bda4-2da6-4c20-855d-2888dadf0c3a | 2026-07-28 | Warnings | M012 9D2RTI9KYH 495W7451VQ |
| DM Maximum | DEXTROMETHORPHAN HBR, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | f6029b04-e681-40fc-be4f-14091b76dd4e | 2026-07-27 | Warnings | M012 9D2RTI9KYH 495W7451VQ |
| Pain Reliever PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | L.N.K. International, Inc. | 03b871e8-3e14-4ed8-a978-45129255b272 | 2026-07-27 | Warnings | 362O9ITL9D |
| Allergy Relief | DIPHENHYDRAMINE HCL | CVS PHARMACY | e958eef1-8aae-4365-ac64-95a9e8e7e0f2 | 2026-07-27 | Warnings | M012 |
| OXYCODONE AND ACETAMINOPHEN | OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN | SpecGx LLC | f2137f1a-b49a-40bd-97ac-cd6b36e295f4 | 2026-07-27 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Topwin Speedy Enema | GLYCERIN | Health Chemical Pharmaceutical Co., Ltd | 3ba8c3d2-1780-42e1-bec5-8f98771d475e | 2026-07-27 | Warnings | PDC6A3C0OX |
| Allergy Relief | DIPHENHYDRAMINE HCL | DOLGENCORP INC | 38400854-27fa-e291-e063-6294a90a5c4e | 2026-07-27 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Better Living Brands, LLC | 65802aa7-64e7-4435-ad6b-65895fba17ce | 2026-07-27 | Warnings | M012 |
| Cold and Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCL | Walgreen Company | 0a48f650-ad2a-4105-9ff4-2bc4d94b46d3 | 2026-07-27 | Warnings | M012 YAN7R5L890 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| Pain Relief Acetaminophen PM Extra Strength | ACETAMINOPHEN AND DIPHENHYDRAMINE HCL | Rite Aid Corporation | 17d27771-a112-474f-9a58-29af0d7e1af3 | 2026-07-27 | Warnings | 362O9ITL9D |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | 84202ebe-97b6-4be2-bb09-7f2729303f96 | 2026-07-27 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D 495W7451VQ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.