NDC 51316-004 - 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
- 51316-004
- Package NDCs from labels
- 51316-004-45
- 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 |
|---|---|---|---|---|---|---|
| 51316-004-45 | Severe Congestion, Cough, Cold and Flu ReliefMaximum Strength, Nighttime | 177 mL in 1 BOTTLE, PLASTIC | SOLUTION | 177 mL | 400 mg in 20mL | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51316-004 | 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 |
|---|---|---|---|---|---|---|
| Defensol Adult Syrup | GUAIFENESIN, DEXTROMETHORPHAN HBR | Menper Distributors, Inc. | 62acff69-8c40-4a0e-8d56-be2cc14e3d45 | 2025-07-22 | Warnings | M012 9D2RTI9KYH 495W7451VQ |
| Gesteira | ACETAMINOPHEN | Menper Distributors, Inc. | 5a907289-564c-491b-98d5-d7f43eaaa1b2 | 2025-07-22 | Warnings | 362O9ITL9D |
| Cosedal Drops | DEXTROMETHORPHAN HBR, GUAIFENESIN | Menper Distributors, Inc. | 1241d249-ea3b-4d2b-87ed-835d6a2d286a | 2025-07-22 | Warnings | M012 9D2RTI9KYH 495W7451VQ |
| Berro y Cebolla DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Menper Distributors, Inc. | 20107bd9-6d84-4ab5-a0d9-966f1f11d919 | 2025-07-22 | Warnings | M012 9D2RTI9KYH 495W7451VQ |
| Defensol-ito | DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE | Menper Distributors, Inc | a7c7a60d-d49f-4239-92f7-714eac7eb0c5 | 2025-07-22 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 495W7451VQ |
| Bisolvine Children | GUAIFENESIN, DEXTROMETHORPHAN | MENPER DISTRIBUTORS INC. | 896a5443-e3d2-4af7-9e27-f1c1899ce038 | 2025-07-22 | Warnings | M012 9D2RTI9KYH 495W7451VQ |
| Bisolvine Aloe-Miel | DEXTROMETHORPHAN, GUAIFENESIN | MENPER DISTRIBUTORS INC. | 34801c79-ce88-492f-808e-b639e8601607 | 2025-07-22 | Warnings | M012 9D2RTI9KYH 495W7451VQ |
| Viva Porru Chest Rub | CAMPHOR, MENTHOL, EUCALYPTUS OIL | Menper Distributors, Inc. | 0dfadfe3-9e40-0eee-e063-6294a90a00c3 | 2025-07-22 | Warnings | M012 |
| leader childrens allergy relief | DIPHENHYDRAMINE HCL | Cardinal Health 110, LLC. dba Leader | 40d697b7-dc59-4d24-8d46-db635e01b9d5 | 2025-07-22 | Warnings | M012 |
| Cold Sore Fast-Acting Pain Relief | GLYCERIN AND LIDOCAINE | Blistex Inc. | c7511322-dd6c-441c-bf7d-ad4f0c14956a | 2025-07-22 | Warnings | PDC6A3C0OX |
| Extra strength Acetaminophen PM | ACETAMINOPHEN 500MG/ DIPHENHYDRAMINE HCL 25MG | TIME CAP LABS INC | 010c5c98-fc67-a9c3-e063-6394a90aa640 | 2025-07-21 | Warnings | 362O9ITL9D |
| Cureforte Breath Reset | MOUTH SPRAY | STEEL CITY HEALTH PRIVATE LIMITED | 38ddf1a7-29ab-cb8d-e063-6294a90ad34c | 2025-07-21 | Warnings | PDC6A3C0OX |
| GoodSense Hemorrhoidal Pain Relief | GLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCL | Perrigo Direct, Inc | 2e5f699d-45e8-6451-e063-6394a90a8ad8 | 2025-07-20 | Warnings | PDC6A3C0OX 04JA59TNSJ |
| Allergy Relief | CHLORPHENIRAMINE MALEATE | Chain Drug Consortium | 34005c55-3176-4f28-9a3b-7dc6fefd01fe | 2025-07-19 | Warnings | M012 |
| Sinus Relief Daytime Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL | Kroger Company | 73a77a13-983b-4e65-bb3c-2ba5e9f33a3e | 2025-07-19 | Warnings | M012 |
| QUALITY CHOICE No Drip Nasal Mist | OXYMETAZOLINE HYDROCHLORIDE | QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) | 7cb6ad04-7847-46b9-b371-0a3473001c79 | 2025-07-18 | Warnings | M012 |
| Dual Action | ACETAMINOPHEN AND IBUPROFEN (NSAID) TABLETS, 250 MG/ 125 MG | Dr. Reddy's Laboratories Inc | c8a8a18a-6766-37a9-d0f0-f9380fb5b0e8 | 2025-07-18 | Warnings | 362O9ITL9D |
| childrens pain and fever | ACETAMINOPHEN | Meijer Distribution Inc | 44d50d79-6e47-429f-8cbe-6fcac4667732 | 2025-07-18 | Warnings | 362O9ITL9D |
| Nasal Decongestant Maximum Strength | PSEUDOEPHEDRINE HCL | Chain Drug Consortium | 270e9221-d305-4148-b523-741e02fe733f | 2025-07-18 | Warnings | M012 |
| ACTISPEC PSE | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE | ACTIPHARMA, LLC | 5def1555-87f4-41d5-8a5c-be560aa8f1e2 | 2025-07-17 | Warnings | M012 9D2RTI9KYH 495W7451VQ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.