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 |
|---|---|---|---|---|---|---|
| Diphenhydramine | DIPHENHYDRAMINE HYDROCHLORIDE | Fresenius Kabi USA, LLC | f4f0c26b-dad0-47a1-a9e7-6558c11254c0 | 2025-04-15 | Warnings, Adverse reactions | TC2D6JAD40 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 9382c976-3067-4923-a38f-101d1c481e97 | 2025-04-11 | Warnings | M012 TC2D6JAD40 |
| Daytime Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HCL LIQUID FILLED CAPSULES | Walmart Inc. | 263d31c8-bdc2-a289-e063-6394a90a4aaa | 2025-04-10 | Warnings | M012 |
| Advil Allergy and Congestion Relief | CHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDE | Haleon US Holdings LLC | a6cc97d8-252a-4527-a470-6d9e356342fd | 2025-04-09 | Warnings | 04JA59TNSJ |
| Bio Co Enzyme Phase | ACONITICUM ACIDUM, CIS-, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ADRENALINUM, , ALPHA-KETOGLUTARICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, ASCORBICUM ACIDUM, BARIUM OXALSUCCINICUM, BETA VULGARIS, CERIUM OXALICUM, CITRICUM ACIDUM, CYSTEINUM, FUMARICUM ACIDUM, HEPAR SULPHURIS CALCAREUM, MAGNESIUM OROTICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM PHOSPHORICUM, NADIDUM, NATRUM OXALACETICUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PANTOTHENIC ACID, PROTEUS (MORGANI), PULSATILLA (PRATENSIS), PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, | Deseret Biologicals, Inc. | 6edee6eb-0ec9-4d2a-9dc9-dc2a6503a6db | 2025-04-08 | Warnings | XF417D3PSL |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | Xttrium Laboratories, Inc | 30c9d769-bc74-04d2-e063-6294a90a665a | 2025-04-07 | Warnings, Adverse reactions | 9D2RTI9KYH |
| Guaifenesin and Dextromethorphan HBr | GUAIFENESIN AND DEXTROMETHORPHAN HBR | Aurohealth LLC | 02d2a5a6-36bb-45b5-aba7-779615b276ed | 2025-04-05 | Warnings | 9D2RTI9KYH |
| CVS Wild Cherry Throat Drop | PECTIN | CVS | 31f4b641-e9c0-786e-e063-6394a90aa253 | 2025-04-04 | Warnings | M012 |
| Diphenhydramine hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 829bbcbf-fb27-4484-aff6-a7e7467670af | 2025-04-03 | Warnings, Adverse reactions | TC2D6JAD40 |
| Nighttime Ultra Concentrated Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE SOFTGELS | WALGREENS | 2be0a699-e6ad-ef56-e063-6394a90aaca5 | 2025-04-03 | Warnings | M012 9D2RTI9KYH |
| Sleep Aid | DIPHENHYDRAMINE HCL | QUALITY CHOICE (Chain Drug Marketing Association) | 25f32a1c-0687-45e9-8142-96cf63599090 | 2025-04-03 | Warnings | TC2D6JAD40 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Fresenius Kabi USA, LLC | 6d1aa0e2-036d-4382-a458-fc0300dba7cb | 2025-04-03 | Warnings, Adverse reactions | TC2D6JAD40 |
| Cough and Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 44fb27d3-5125-4511-84d2-76555bc46e66 | 2025-04-03 | Warnings | M012 9D2RTI9KYH |
| Eye Wash | WATER | CMC Group Inc. | 6158a1f5-a6bc-4a3e-9d1d-0a310d9dc561 | 2025-04-02 | Warnings | 059QF0KO0R |
| dextromethorphan polistirex extended release | DEXTROMETHORPHAN POLISTIREX | Bryant Ranch Prepack | bd415342-90e1-411b-b6c9-652e9532c611 | 2025-04-02 | Warnings | 9D2RTI9KYH |
| Guaifenesin | GUAIFENESIN | KESIN PHARMA CORPORATION | 31b8ad0a-3637-03db-e063-6394a90acdc3 | 2025-04-01 | Warnings | M012 |
| Phenylephrine Hydrochloride | PHENYLEPHRINE HYDROCHLORIDE | Alcon Laboratories, Inc. | cacbb3fd-1c03-4523-a1bf-0ccc4be102ef | 2025-04-01 | Warnings, Adverse reactions | 04JA59TNSJ |
| hemorrhoidal | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL | Bionpharma Inc. | 1790da99-2a22-e2a2-e063-6394a90ac36f | 2025-03-31 | Warnings | 04JA59TNSJ |
| Pharmacys Prescription Vapor Rub | MENTHOL | American Consumer Products Corp | 31aa54d8-df8d-f1ae-e063-6294a90a9622 | 2025-03-31 | Warnings | M012 |
| Guaifenesin | GUAIFENESIN | Bryant Ranch Prepack | 570a71eb-2d19-4c7b-8c00-e1524bfa3844 | 2025-03-31 | Warnings | M012 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.