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 |
|---|---|---|---|---|---|---|
| Acetaminophen | ACETAMINOPHEN | PAI Holdings, LLC dba PAI Pharma | fac4e0c6-684f-45a1-99f2-de4de4017cc8 | 2025-12-11 | Warnings | 362O9ITL9D |
| Pain Reliever PM extra strength | ACETAMINOPHEN DIPHENHYDRAMINE HCL | P & L Development, LLC | 90eba2e8-52c3-43f5-ba93-4a520368c7f4 | 2025-12-11 | Warnings | 362O9ITL9D |
| Sinus PE Congestion | DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Walgreen Company | 5b9151b7-3e40-4f37-b3e0-4c0fa0115b71 | 2025-12-10 | Warnings | M012 |
| Cough and Cold HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Discount Drug Mart | 2344c048-0550-4c31-b54e-a198910c490e | 2025-12-10 | Warnings | M012 9D2RTI9KYH |
| TopCare Cough DM | DEXTROMETHORPHAN POLISTIREX | Topco Associates LLC | 490f695c-e60f-43db-b3f3-a9ffbb2906dd | 2025-12-10 | Warnings | 9D2RTI9KYH |
| Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate | BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE | Actavis Pharma, Inc. | 52321fe5-c001-4e2d-8149-3197ddc13764 | 2025-12-10 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| CVS Maximum Strength Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCL | CVS PHARMACY, INC | cf4eb4c4-68e0-4478-a81c-d3d1e66f5cc5 | 2025-12-10 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| Acetaminophen | ACETAMINOPHEN | CHAIN DRUG MARKETING ASSOCIATION INC | 2e30754a-42f7-4da2-944c-be61cee47b43 | 2025-12-10 | Warnings | 362O9ITL9D |
| Midol Complete, Travel BASIX | ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE | Lil' Drug Store Products, Inc | d6d47af8-5f8c-4c8c-a8c6-aa214ec23bca | 2025-12-10 | Warnings | 362O9ITL9D |
| MAX relief junior | ACETAMINOPHEN | ATLANTIC BIOLOGICALS CORP. | ff1f6f82-0c7c-4e3f-a2bd-3185e16fa770 | 2025-12-10 | Warnings | 362O9ITL9D |
| Tylenol Cold plus Flu Severe, Lil Drug Store | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Lil Drug Store Products, Inc | f395c196-62d7-47ff-b38d-af37adf5980b | 2025-12-10 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| Tylenol Sinus Severe, Lil Drug Store | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Lil Drug Store Products, Inc | 88b68447-b016-4d5b-a5e3-c4ebccb14f8c | 2025-12-10 | Warnings | M012 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| Tylenol PM Extra Strength, CVP HEALTH | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | Lil' Drug Store Products, Inc. | 643371f2-e330-441e-8932-b3aec4b179d2 | 2025-12-10 | Warnings | 362O9ITL9D |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Advanced Rx of Tennessee, LLC | 45a18fad-ad4e-3a1b-e063-6394a90a23cf | 2025-12-10 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Capron DMT | DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE | Capital Pharma | 50222df4-5c31-1304-e054-00144ff88e88 | 2025-12-10 | Warnings | 9D2RTI9KYH |
| FCS HP | EPINEPHRINE,GLUTAMICACID,MUCUNAPRURIENSSEED,NIACINAMIDE,SEROTONIN,UBIDECARENONE,CORTICOTROPIN,ADENOSINETRIPHOSPHATE,INSULINPORK,SUSSCROFAPARATHYROIDGLAND,SUSSCROFAPITUITARYGLAND,THIAMINEHYDROCHLORIDE,THYROID,ANHYDROUSCITRICACID,HERRINGSPERMDNA,SACCHAROMYCESCEREVISIAERNA,ANACARDIUMOCCIDENTALEFRUIT,ARSENICTRIOXIDE,ASPARTICACID,BARIUMCARBONATE,OYSTERSHELLCALCIUMCARBONATECRUDE,CLEMATISRECTAFLOWERINGTOP,LYCOPODIUMCLAVATUMSPORE,ANEMONEPULSATILLA,DATURASTRAMONIUM,SULFUR | Natural Creations, Inc. | ba8fed68-f27f-4651-adec-0994a5375887 | 2025-12-10 | Warnings | XF417D3PSL |
| Allergy Relief | DIPHENHYDRAMINE HCL | Family Dollar Services Inc | d956f1b8-91f8-424b-bb6c-704c445b6f4c | 2025-12-10 | Warnings | M012 |
| Butalbital, Acetaminophen, and Caffeine | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE | Actavis Pharma, Inc. | ea5b9ffe-3cda-405e-8f75-3fd4a64c9a35 | 2025-12-10 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Mucus Relief D | GUAIFENESIN AND PSEUDOEPHEDRINE HCL | CVS Health Corp | 19cde6f8-649a-df69-7ee9-05da2cccba5b | 2025-12-10 | Warnings | 495W7451VQ |
| good neighbor pharmacy day time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Amerisource Bergen | e5c1bd96-d27d-49c1-b3b8-eee53a145ef5 | 2025-12-10 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.