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 |
|---|---|---|---|---|---|---|
| OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | Direct_Rx | 90a11364-fc42-e94e-e053-2a95a90a9782 | 2025-07-22 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Defensol D | ACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCI | Menper Distributors, Inc. | f466c660-69eb-4581-81ff-1499fa421d8b | 2025-07-22 | Warnings | M012 04JA59TNSJ 362O9ITL9D |
| Dr. Butler Hemorrhoid Treatment | PHENYLEPHRINE HYDROCHLORIDE 0.25%, WITCH HAZEL 50% | Beyond Health P.A. | d2d1c81c-6443-c4b7-e053-2995a90a14d7 | 2025-07-22 | Warnings | 04JA59TNSJ |
| Defensol D Blister Pack | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCI | Menper Distributors, Inc. | 0dfcc977-6101-4536-e063-6294a90a7a48 | 2025-07-22 | Warnings | M012 04JA59TNSJ 362O9ITL9D |
| Duralgina | ACETAMINOPHEN | Menper Distributors Inc. | bb31f66c-80a9-4bdb-983b-cef5d21de5ff | 2025-07-22 | Warnings | 362O9ITL9D |
| ADVIL SINUS CONGESTION AND PAIN | IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE | Haleon US Holdings LLC | b1e29c19-fe03-4d2b-b966-0adf4eb4b4cf | 2025-07-22 | Warnings | 04JA59TNSJ |
| Broncofin | DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Menper Distributors, Inc. | fdf67382-1692-485b-92f1-2cbb8be4fb70 | 2025-07-22 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ |
| 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 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.