NDC 51316-916 - 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
- 51316-916
- Package NDCs from labels
- 51316-916-03
- 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 |
|---|---|---|---|---|---|---|
| 51316-916-03 | Daytime Cold and Cough Nighttime Cold and Congestion | 118 mL in 1 BOTTLE | LIQUID | 118 mL | 1 mg in 5mL | 3 |
| 51316-916-03 | Daytime Cold and Cough Nighttime Cold and Congestion | 1 in 1 CARTON | LIQUID | 5 mg in 5mL | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51316-916 | 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 |
|---|---|---|---|---|---|---|
| Cold Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | b919f0fe-fae0-4bd8-9ccd-d7569b2a7070 | 2025-05-13 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ |
| Childrens Robitussin Honey Nighttime Cough DM | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Haleon US Holdings LLC | 6afaf85b-bf0c-4c99-acf3-a34f06be20f1 | 2025-05-13 | Warnings | M012 9D2RTI9KYH |
| Robitussin Honey Severe Cough, Flu Plus Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | 77be57fb-0ae5-4fad-97f3-b6a4b57383a9 | 2025-05-13 | Warnings | M012 9D2RTI9KYH |
| cough dm | DEXTROMETHORPHAN POLISTIREX | ATLANTIC BIOLOGICALS CORP. | 73aede9d-37dd-4aa5-a906-0e0c94cecff1 | 2025-05-12 | Warnings | 9D2RTI9KYH |
| Allergy | CHLORPHENIRAMINE MALEATE | Bryant Ranch Prepack | c948e612-a491-4ad0-adb9-cf31ef76e4d8 | 2025-05-12 | Warnings | M012 |
| Maximum Strength Nighttime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Prodose, Inc. | c3d0b70f-d213-4e38-88ab-1c89d93a391d | 2025-05-10 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ |
| Childrens Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Safeway, Inc. | c639a36d-c683-4a4d-90b7-eadec7464aa2 | 2025-05-08 | Warnings | M012 TC2D6JAD40 |
| GNP Extra Strength Anti-Itch Cream | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | Amerisource Bergen | 34a66224-ef3c-e36e-e063-6394a90ac99d | 2025-05-08 | Warnings | TC2D6JAD40 |
| SUKKHI Polyamino Sugar Condensate Massage Cream | SUKKHI POLYAMINO SUGAR CONDENSATE MASSAGE CREAM | GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd | 34aaf4ef-26dc-f87e-e063-6394a90a9a59 | 2025-05-08 | Warnings | PDC6A3C0OX |
| Severe Cold | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | cf2dd1fb-1d5b-428e-8c9a-a46dbd7cb645 | 2025-05-07 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | Asclemed USA, Inc. | 702eb7c0-db4c-4729-b69e-99f64c63c7bd | 2025-05-07 | Boxed warning, Warnings, Adverse reactions | 9D2RTI9KYH |
| Cough DM | DEXTROMETHORPHAN POLISTIREX | Meijer Distribution Inc | 3febf0e0-b587-495a-9608-3a2dfbc32791 | 2025-05-07 | Warnings | 9D2RTI9KYH |
| Theraflu Severe Cold Relief Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | 2b962d87-6ff5-4c0f-8504-e5b61c940612 | 2025-05-05 | Warnings | M012 9D2RTI9KYH |
| Walgreens Stop Itch Gel | DIPHENHYDRAMINE HCL | Walgreens Co | 23586336-8f46-3dcd-e063-6394a90accc9 | 2025-05-04 | Warnings | TC2D6JAD40 |
| Cough and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE LIQUID | CVS | 2d13564a-e8d1-c357-e063-6394a90ad90e | 2025-05-02 | Warnings | M012 9D2RTI9KYH |
| SUDAFED OM Sinus Severe No Drip Nasal Mist with Cooling Menthol | OXYMETAZOLINE HYDROCHLORIDE | Kenvue Brands LLC | 33fe0e49-3de5-8afd-e063-6294a90a0ad5 | 2025-05-02 | Warnings | M012 |
| Daytime and Nighttime High Blood Pressure Cold and Flu Liquid | ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | CVS Pharmacy, Inc. | 2d13964a-8cc4-f3dc-e063-6394a90aa105 | 2025-05-02 | Warnings | M012 |
| Rest Simply | DIPHENHYDRAMINE HYDROCHLORIDE | Chain Drug Marketing Association | 54bdb6bc-622c-412a-8365-a1b1c968e13e | 2025-05-01 | Warnings | TC2D6JAD40 |
| Phenylephrine hydrochloride | PHENYLEPHRINE HYDROCHLORIDE | Amneal Pharmaceuticals LLC | fad93be4-32dd-44c1-a20f-2b0bb3b41929 | 2025-05-01 | Warnings, Adverse reactions | 04JA59TNSJ |
| DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML | DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML | AARNA USA INC. | 32c26835-f54e-d7e5-e063-6294a90ae1c0 | 2025-04-30 | Warnings | M012 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.