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 |
|---|---|---|---|---|---|---|
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | P & L Development, LLC | 0bb006f6-c360-4cd5-81e9-0776d99d79e8 | 2025-07-08 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| childrens cold cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Meijer, Inc. | 026e530f-e133-4f20-bac5-354fbb647c9e | 2025-07-08 | Warnings | M012 9D2RTI9KYH |
| good sense pain relief | ACETAMINOPHEN | L. Perrigo Company | af7ae548-38ad-41d5-b1cb-761cd2e386d3 | 2025-07-08 | Warnings | 362O9ITL9D |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | CVS PHARMACY, INC | f59016f3-a8f8-4c95-9414-01440f0574d9 | 2025-07-08 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| ACTINEL PEDIATRIC | DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL | ACTIPHARMA, LLC | 6bb92d74-4893-40b8-af58-eb307155e876 | 2025-07-08 | Warnings | M012 9D2RTI9KYH 495W7451VQ |
| topcare pain relief | ACETAMINOPHEN | Topco Associates LLC | 6aca88df-d3b5-4a60-b23b-1e66dc41ee7b | 2025-07-08 | Warnings | 362O9ITL9D |
| Nighttime Cold and Flu Maximum Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 776b7c67-56c7-420c-82b2-9a176d998396 | 2025-07-08 | Warnings | M012 04JA59TNSJ 362O9ITL9D |
| ACTICON | DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE | ACTIPHARMA, LLC | 847014ab-86ae-40c5-8e7f-f1ddea14f1b3 | 2025-07-08 | Warnings | M012 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Genus Lifesciences Inc. | a9fb9779-76a5-407a-a155-84f198004ae2 | 2025-07-08 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| equate childrens pain and fever | ACETAMINOPHEN | Wal-Mart Stores Inc | f15037a5-4e43-4dd6-93b8-b37a1cc22cd6 | 2025-07-07 | Warnings | 362O9ITL9D |
| Mucus Relief | GUAIFENESIN 400 MG | Cabinet Health, Inc. | 26a51b0e-039c-663c-e063-6394a90ad384 | 2025-07-07 | Warnings | M012 495W7451VQ |
| Sodium Citrate and Citric Acid | SODIUM CITRATE AND CITRIC ACID MONOHYDRATE | Belleview Biosciences LLC | 3245e0e5-5e7f-c3f7-e063-6394a90ac258 | 2025-07-07 | Adverse reactions | XF417D3PSL |
| EZ Nite Sleep | DIPHENHYDRAMINE HCL | Safeway, Inc. | 21a68c60-3005-43bb-8ec5-7982239c93f8 | 2025-07-07 | Warnings | M012 |
| dg health dual back pain reliever | ACETAMINOPHEN, IBUPROFEN | Dolgencorp Inc | b52cfead-1cff-4e11-9953-f470fb785c73 | 2025-07-07 | Warnings | 362O9ITL9D |
| Childrens Acetaminophen Oral Liquid Grape Flavor | ACETAMINOPHEN | AARNA USA INC. | 39347f5d-2d3c-0c23-e063-6294a90a3a46 | 2025-07-05 | Warnings | 362O9ITL9D |
| MUCUS RELIEF | GUAIFENESIN 400 MG | Pioneer Life Sciences, LLC | 8188b66a-5405-4e62-bde6-63ebc1f22b16 | 2025-07-04 | Warnings | M012 495W7451VQ |
| Phenylephrine Hydrochloride | PHENYLEPHRINE HYDROCHLORIDE | Fresenius Kabi USA, LLC | b54a0c59-e5e4-4fd7-ba91-c991ce87b148 | 2025-07-04 | Warnings, Adverse reactions | 04JA59TNSJ |
| nasal | OXYMETAZOLINE HYDROCHLORIDE | Meijer, Inc. | fdeadc2e-43e4-40d5-aebf-0e528f0a8b5a | 2025-07-03 | Warnings | M012 |
| Cabinet Allergy Relief Refill Diphenhydramine HCI | DIPHENHYDRAMINE HYDROCHLORIDE | Cabinet Health P.B.C. | d47553a4-ca15-4f0a-8177-d743a5c39cc5 | 2025-07-03 | Warnings | M012 |
| Acetaminophen and Ibuprofen | ACETAMINOPHEN AND IBUPROFEN | Aurohealth LLC | b39fb93f-c140-40ab-8247-9559ef6df50a | 2025-07-03 | Warnings | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.