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 |
|---|---|---|---|---|---|---|
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Walgreens | f2eb9575-d527-44c7-aa5e-efabfd9a0278 | 2025-10-07 | Warnings | 362O9ITL9D |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 72244b9c-eac4-41c2-8ba6-7302eafba90a | 2025-10-07 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Acetaminophen PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | CHAIN DRUG MARKETING ASSOCIATION INC | bbc704e5-79f6-4c72-846b-cc30c5c43cb4 | 2025-10-07 | Warnings | 362O9ITL9D |
| Mitochondria PRO | ARALIA QUINQUEFOLIA, ARNICA MONTANA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, ASCORBICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CALCAREA CARBONICA, CITRICUM ACIDUM, CUPRUM METALLICUM, CYSTEINUM, FERRUM METALLICUM, IODIUM, LEVOTHYROXINUM, MAGNESIUM GLUCONICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM ACETICUM, NADIDUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SELENIUM METALLICUM, SULPHUR, THIAMINUM HYDROCHLORICUM, UBIDECARENONUM, ZINCUM METALLICUM, | Energique, Inc. | 8c3e961d-bc33-40cd-a282-a4fe5aa3f0ad | 2025-10-06 | Warnings | XF417D3PSL |
| OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution | DIPHENHYDRAMINE HCL | MEDWISE LIFESCIENCES INC. | 407b7cbb-7ebd-7b7e-e063-6394a90af501 | 2025-10-06 | Warnings | M012 |
| Quality Choice Medicated Chest Rub | CAMPHOR, MENTHOL, EUCALYPTUS OIL | Quality Choice (CHAIN DRUG MARKETING ASSOCIATION) | d0cce0a0-a6bc-4c45-b9c6-08865b61c1dc | 2025-10-06 | Warnings | M012 |
| Halls Sugar Free Honey Lemon | MENTHOL | Mondelez Global LLC | 2b19fdd2-8088-47f2-be20-f220a6b825fc | 2025-10-06 | Warnings | M012 |
| Giltuss Childrens Cough and Chest Congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Dextrum Laboratories, Inc | 40802fb6-c1ec-d7b0-e063-6394a90ab423 | 2025-10-06 | Warnings | M012 9D2RTI9KYH 495W7451VQ |
| Giltuss Diabetic | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Dextrum Laboratories, Inc | 3f64c81a-bbfc-4575-e063-6294a90a6ed7 | 2025-10-06 | Warnings | M012 495W7451VQ |
| TexaClear Severe Cough, Cold and Flu | CHOLINE SALICYLATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | GM Pharmaceuticals, INC | cb99e5b3-1908-43c9-b31f-d35e7ce58b44 | 2025-10-06 | Warnings | M012 9D2RTI9KYH 495W7451VQ |
| BupropiDex | DEXTROMETHORPHAN HYDROBROMIDE | DXM Pharmacuetical, Inc. | 90cc9bcd-7891-4324-a1f4-f6df7a0457e0 | 2025-10-06 | Warnings | 9D2RTI9KYH |
| Dextabs | DEXTROMETHORPHAN HYDROBROMIDE | DXM Pharmacuetical, Inc. | 71b567df-844a-4563-b85a-f4592233f37d | 2025-10-06 | Warnings | 9D2RTI9KYH |
| RoboHBr Cough SUPPRESSANT | DEXTROMETHORPHAN HBR | DXM Pharmaceutical, Inc | 0af624ce-191f-45e1-882b-e8acb90cc77b | 2025-10-06 | Warnings | M012 9D2RTI9KYH |
| RoboTablets | DEXTROMETHORPHAN | DXM Pharmaceutical, Inc | b92cf698-032d-4d8d-b19c-456c6338b094 | 2025-10-06 | Warnings | M012 |
| SinuLief | LORATADINE | RoseWell Pharmaceuticals LLC | 32619143-a782-3497-e063-6394a90aaaec | 2025-10-06 | Warnings | M012 |
| Acetaminophen, Aspirin and Caffeine | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | Rising Pharma Holdings, Inc. | 50f72713-50f5-4bab-9e96-b9fa73c9df1f | 2025-10-06 | Warnings | 362O9ITL9D |
| Care One arthritis pain relief | ACETAMINOPHEN | American Sales Company | c5865a69-4fe4-4f0d-9e03-5927dd737445 | 2025-10-06 | Warnings | 362O9ITL9D |
| Kidnex IV | GINKGO BILOBA, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALICUM ACIDUM, PYRUVIC ACID, SUCCINICUM ACIDUM, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, GERMANIUM SESQUIOXIDE, MERCURIUS VIVUS, NUX VOMICA, KIDNEY (SUIS), LYMPH NODE (SUIS), NAPHTHOCHINONUM, NATRUM OXALACETICUM, PHOSPHORUS, URINARY BLADDER (SUIS), ACONITICUM ACIDUM, CIS- | Energique, Inc. | 121eb51a-befe-47ea-85c6-d77e8c7e5864 | 2025-10-06 | Warnings | XF417D3PSL |
| OneSsip Acetaminophen Oral Suspension Bubble Gum 5 mL | ACETAMINOPHEN 160 MG / 5 ML | MEDWISE LIFESCIENCES INC. | 40507559-aee4-a603-e063-6394a90afc4f | 2025-10-04 | Warnings | 362O9ITL9D |
| STAHIST AD | CHLORCYCLIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | Magna Pharmaceuticals, Inc. | ccedbc38-2479-4c35-9f86-a9f29bcfab3f | 2025-10-03 | Warnings | M012 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.