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 |
|---|---|---|---|---|---|---|
| Rompe Tos X Adults | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | OPMX LLC | 05abb2db-d22e-90b5-e063-6294a90ace3f | 2025-03-19 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| Sinus Head Congestion | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE | VIVUNT PHARMA LLC | 30a07773-bd6f-b9f2-e063-6394a90ab8aa | 2025-03-18 | Warnings | M012 04JA59TNSJ 362O9ITL9D |
| Pain Reliever PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | TARGET Corporation | 1fc3806e-a5c4-4a6e-951b-dfbf9f5771f1 | 2025-03-17 | Warnings | 362O9ITL9D |
| Mucus Relief | GUAIFENESIN | H E B | efebda97-5234-451c-a854-91a32303a6b7 | 2025-03-17 | Warnings | 495W7451VQ |
| Halls Sugar Free Black Cherry | MENTHOL | Mondelez Global LLC | bd2a311a-bf0c-4365-af9b-76675c243b22 | 2025-03-16 | Warnings | M012 |
| Medicated Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | TARGET CORPORATION | fbca9627-5e12-048a-e053-6294a90a6e0f | 2025-03-15 | Warnings | M012 |
| Medicated Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | DOLGENCORP, INC. | 0655688e-7c42-507f-e063-6294a90ae498 | 2025-03-15 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | CVS PHARMACY, INC | 1b8d5494-1fcf-4cd0-acc0-34f17d577bd7 | 2025-03-14 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| GOOD REMEDIES Extra Strength Pain Relief PM Caplet | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | Strive Pharmaceuticals Inc. | 2d642d8e-c154-a970-e063-6294a90a03bf | 2025-03-14 | Warnings | 362O9ITL9D |
| BRONCOCHEM MAXIMUM COUGH KIDS | DEXTROMETHORPHAN HBR-GUAIFENESIN | LABORATORIO MAGNACHEM INTERNATIONAL SRL | b0fd2f2f-5cc4-4813-8f99-c78fbe898656 | 2025-03-13 | Warnings | 9D2RTI9KYH 495W7451VQ |
| Excedrin Migraine Relief | ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE | Haleon US Holdings LLC | dd85f3a7-f4d2-4ea0-a7b6-18ebc0e993d8 | 2025-03-11 | Warnings | 362O9ITL9D |
| Ultra Concentrated Daytime COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | PuraCap Pharmaceutical LLC | 300b2357-933b-fe9a-e063-6294a90aa4b9 | 2025-03-11 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| Ultra Concentrated Nighttime COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | PuraCap Pharmaceutical LLC | 300bf27f-744f-7366-e063-6394a90acbcb | 2025-03-11 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| Daytime COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | PuraCap Pharmaceutical LLC | 300c7c7b-ea0b-3650-e063-6294a90a65e8 | 2025-03-11 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| Rompe Pecho Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | EFFICIENT LABORATORIES INC | 2ec319a8-92bf-4552-86dd-37cbce18980f | 2025-03-11 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| Addiclenz | ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, BETA VULGARIS, BISPHENOL A, BOLDO, CHELIDONIUM MAJUS, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PETROSELINUM SATIVUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, TARAXACUM OFFICINALE, ZINCUM METALLICUM | Deseret Biologicals, Inc. | 25036c26-1c21-4e5a-b4db-b8e177458341 | 2025-03-11 | Warnings | OJ245FE5EU |
| Aspartame/MSG Detox | CHELIDONIUM MAJUS, ARNICA MONTANA, PHYTOLACCA DECANDRA, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, BISPHENOL A (BPA), DEXTROSE, MALTODEXTRIN, SUCRALOSE, ASPARTIC ACID, DIKETOPIPERAZINE, DOPAMINE HYDROCHLORIDE, FORMALINUM, FORMICUM ACIDUM, L-PHENYLALANINE, METHYL ALCOHOL, MONOSODIUM GLUTAMATE | Deseret Biologicals, Inc. | a1dc1bf3-db71-4550-a975-4f146fb94005 | 2025-03-11 | Warnings | 96K6UQ3ZD4 |
| Excedrin Migraine | ACETAMINOPHEN, ASPIRIN, AND CAFFEINE | Haleon US Holdings LLC | 910d7254-d0f4-4c5c-a26e-7f8acecbe02d | 2025-03-11 | Warnings | 362O9ITL9D |
| Sudafed PE Head Congestion Plus Pain | IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 76513fb2-7323-4f1f-8a10-92f8f603cf97 | 2025-03-10 | Warnings | 04JA59TNSJ |
| HISTEX-DM New Formulation | DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCI, AND TRIPROLIDINE HCI | Allegis Pharmaceuticals, LLC | 30010401-e5b4-2bd9-e063-6394a90a0b0b | 2025-03-10 | Warnings | M012 YAN7R5L890 9D2RTI9KYH |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.