NDC 51316-919 - Daytime Cold and Cough Nighttime Cold and Congestion
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
- 51316-919
- Package NDCs from labels
- 51316-919-03
- Manufacturer
- CVS | Guardian Drug Company
- Effective date
- 2026-03-16
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Childrens Daytime Cold and cough - CVS | Guardian Drug Company | CVS | Guardian Drug Company | 2026-03-16 | Human OTC Drug Label |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51316-919-03 | Daytime Cold and Cough Nighttime Cold and Congestion | 118 mL in 1 BOTTLE | LIQUID | 118 mL | 6.25 mg in 5mL | 3 |
| 51316-919-03 | Daytime Cold and Cough Nighttime Cold and Congestion | 1 in 1 CARTON | LIQUID | 6.25 mg in 5mL | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51316-919 | DAYTIME COLD AND COUGH NIGHTTIME COLD AND CONGESTION (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [CVS] | 2 | Unmatched | 20250206_2cf361eb-6055-2364-e063-6294a90a69a1.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 |
|---|---|---|---|---|---|---|
| Sinus Congestion and Pain Maximum Strength | ACETAMINOPHEN, PHENYLEPHRINE HCL | Rugby Laboratories | fc42e97d-1224-4d29-a55d-1a1885e0bf8f | 2026-07-09 | Warnings | M012 04JA59TNSJ |
| Head Congestion and Mucus | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Cardinal Health 110, LLC. DBA Leader | 7418d92d-a540-40d6-91d0-b7eb1f87f8ff | 2026-07-08 | Warnings | M012 04JA59TNSJ |
| Dextromethorphan Hydrobromide and Quinidine Sulphate | DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULPHATE | Sun Pharmaceutical Industries, Inc. | 92b54ac4-594e-47b8-a4d3-394a29b425f3 | 2026-07-08 | Warnings, Adverse reactions | 9D2RTI9KYH |
| Freskaro Ear Drops for Swimmers | FRESKARO EAR DROPS FOR SWIMMERS | Pharma Nobis, LLC | 4f724d85-cd38-41da-e063-6394a90a9fd7 | 2026-07-08 | Warnings | PDC6A3C0OX |
| CAREALL Hemorrhoidal | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL | New World Imports, Inc | 561c601f-c2cd-f09c-e063-6294a90adb45 | 2026-07-08 | Warnings | 04JA59TNSJ |
| DG HEALTH COUGH AND CHEST CONGESTION | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Dolgencorp Inc | 5d9d57aa-e43a-4dbe-9d35-36a7b82d4e6d | 2026-07-08 | Warnings | M012 9D2RTI9KYH |
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | Topco Associates, LLC | bfcabe02-7961-4407-a748-8cd087731398 | 2026-07-08 | Warnings | M012 TC2D6JAD40 |
| Aller-chlor | CHLORPHENIRAMINE MALEATE | Rugby Laboratories | 04ca3806-72be-47d4-9fea-5b0dee087683 | 2026-07-08 | Warnings | M012 |
| nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 24c22c9f-0c2f-46dc-850e-ed05f00d3e95 | 2026-07-08 | Warnings | M012 9D2RTI9KYH |
| NITETIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Meijer, Inc. | 0e65c5d1-a18b-452c-9be6-8d44d34577e9 | 2026-07-08 | Warnings | M012 9D2RTI9KYH |
| Allergy Relief 4 Hour | CHLORPHENIRAMINE MALEATE | Cardinal Health 110, LLC. DBA Leader | aaecfda5-1a50-4d8a-9909-7153c1a22bda | 2026-07-08 | Warnings | M012 |
| nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 7cb9f378-5d64-475f-bf26-4058ba6c15b4 | 2026-07-08 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ |
| DG HEALTH DAY TIME INTENSE FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Dolgencorp Inc | f174d08e-3335-4cc9-8766-4070f18c4f31 | 2026-07-08 | Warnings | M012 9D2RTI9KYH |
| Mucus Relief | GUAIFENESIN 400 MG | Health Pharma USA LLC | d60a3e9d-e88e-3b19-e053-2995a90a3e8d | 2026-07-07 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Health Pharma USA LLC | d38f47ea-7fda-170b-e053-2995a90adc82 | 2026-07-07 | Warnings | M012 TC2D6JAD40 |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HCL 25 MG | Health Pharma USA LLC | d659f747-9790-8bd6-e053-2995a90ae793 | 2026-07-07 | Warnings | TC2D6JAD40 |
| Guaifenesin 200mg | GUAIFENESIN | Health Pharma USA LLC | d68222f7-b796-7b27-e053-2995a90a2efe | 2026-07-07 | Warnings | M012 |
| Artificial Tears | ARTIFICIAL TEARS | AvPAK | f18bebf2-1936-658f-e053-2a95a90a5012 | 2026-07-07 | Warnings | PDC6A3C0OX |
| naproxen sodium pm | DIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUM | Meijer Distribution Inc | 34d635f8-9703-4c29-92a5-85d3b47c4c93 | 2026-07-07 | Warnings | TC2D6JAD40 |
| Cold and Flu Severe Day Time / Night Time | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | DOLGENCORP, LLC | acdcc6ce-c190-4de6-b126-62fe9043112e | 2026-07-07 | Warnings | M012 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.