Home NDC 51316-916 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 Package Descriptions# Package NDC, Product, Description table 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 table 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.
Matched openFDA labels page 100 of 263 · 5,255 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join NeoTuss Plus DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals 2f3c6b38-7236-899b-e063-6294a90aabde 2025-12-18 Warnings Exact identifier application number: M012 unii: 9D2RTI9KYH unii: 04JA59TNSJ QUALITY CHOICE Cough Drops Black Cherry SUGAR FREE MENTHOL Chain Drug Marketing Association, Inc. 8f6ee01c-baad-489f-b2fd-0ef506916ee4 2025-12-18 Warnings Exact identifier application number: M012 Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE ProPharma Distribution 3842d802-9b18-2c5e-e063-6394a90ae763 2025-12-18 Warnings, Adverse reactions Exact identifier unii: TC2D6JAD40 Phenylephrine hydrochloride PHENYLEPHRINE HYDROCHLORIDE ProPharma Distribution 386663e8-f1f6-cf14-e063-6394a90a68df 2025-12-18 Warnings, Adverse reactions Exact identifier unii: 04JA59TNSJ menthol cough drops MENTHOL Meijer 5baeaff7-172c-187a-e053-2a91aa0ab165 2025-12-18 Warnings Exact identifier application number: M012 Sterile Water WATER ProPharma Distribution 386a0a2f-4ff7-f128-e063-6294a90a7d4d 2025-12-18 Warnings, Adverse reactions Exact identifier unii: 059QF0KO0R Menthol Cough Drops MENTHOL Meijer Distribution Inc. 3bee752a-4141-1f5b-e054-00144ff8d46c 2025-12-18 Warnings Exact identifier application number: M012 cherry cough drops MENTHOL Meijer 5bc2ec81-a3cb-3a59-e053-2a91aa0ac14e 2025-12-18 Warnings Exact identifier application number: M012 cherry cough drops MENTHOL Meijer 5bc3b9b8-e61e-1041-e053-2a91aa0a3d83 2025-12-18 Warnings Exact identifier application number: M012 honey lemon cough drops MENTHOL Meijer 5bd35bce-cd85-5314-e053-2991aa0abce6 2025-12-18 Warnings Exact identifier application number: M012 honey lemon cough drops MENTHOL Meijer 5bd42654-56e5-997e-e053-2a91aa0afd34 2025-12-18 Warnings Exact identifier application number: M012 sugar free menthol cough drops MENTHOL Meijer 5bd61cd4-a5ca-9d66-e053-2a91aa0a93a3 2025-12-18 Warnings Exact identifier application number: M012 sugar free honey lemon cough drops MENTHOL Meijer 5bd7c24d-6a61-5d2d-e053-2a91aa0a08ed 2025-12-18 Warnings Exact identifier application number: M012 PREPARATION H PHENYLEPHRINE HYDROCHLORIDE Haleon US Holdings LLC 40fde50a-3cc0-4286-9b33-8f3912254c33 2025-12-18 Warnings Exact identifier unii: 04JA59TNSJ SF Honey Lemon Cough Drops MENTHOL Meijer Distribution 70e3de9a-1804-ef15-e053-2a95a90a3340 2025-12-18 Warnings Exact identifier application number: M012 Acetaminophen Diphenhydramine HCl ACETAMINOPHEN DIPHENHYDRAMINE HCL BETTER LIVING BRANDS LLC. ac0f8d5c-d200-1156-e053-2a95a90aece6 2025-12-18 Warnings Exact identifier unii: TC2D6JAD40 Naproxen Sodium Diphenhydramine Hydrochloride NAPROXEN SODIUM DIPHENHYDRAMINE HYDROCHLORIDE SAFEWAY ed0f3275-f156-13a3-e053-2a95a90a2ce8 2025-12-18 Warnings Exact identifier unii: TC2D6JAD40 A Health Itch Relief Gel ITCH RELIEF GEL Bionpharma, Inc. ecf5decb-c98b-7739-e053-2995a90a5541 2025-12-18 Warnings Exact identifier unii: TC2D6JAD40 QUALITY CHOICE Cough Drops Vanilla Honey MENTHOL Chain Drug Marketing Association, Inc. 3d6a4bcc-1044-40f5-928a-378ececcb687 2025-12-18 Warnings Exact identifier application number: M012 Meijer Strawberry Cough Drops MENTHOL Meijer 164de637-e644-711c-e063-6294a90a1c5f 2025-12-18 Warnings Exact identifier application number: M012
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.