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 table
LabelManufacturerEffective dateType
Childrens Daytime Cold and cough - CVS | Guardian Drug CompanyCVS | Guardian Drug Company2026-03-16Human OTC Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-919-03Daytime Cold and Cough Nighttime Cold and Congestion118 mL in 1 BOTTLELIQUID118 mL6.25 mg in 5mL3
51316-919-03Daytime Cold and Cough Nighttime Cold and Congestion1 in 1 CARTONLIQUID6.25 mg in 5mL3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-919DAYTIME COLD AND COUGH NIGHTTIME COLD AND CONGESTION (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [CVS]2Unmatched20250206_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 252 of 256 · 5,119 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERB. Braun Medical Inc.8924e52e-8622-4ed6-a061-1908183e0a182021-08-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
basic care childrens cough dmDEXTROMETHORPHAN POLISTIREXAmazon.com Services LLCdcfb71a1-2a5b-4847-a23d-bbe381badcf62021-07-20WarningsExact identifier
unii: 9D2RTI9KYH
Signature Care Cough ReliefDEXTROMETHORPHAN POLISTIREXSafewayf95d0519-e96b-45fe-974c-8fe6b9b8c88c2021-07-13WarningsExact identifier
unii: 9D2RTI9KYH
basic care mucus dmDEXTROMETHORPHAN HBR, GUAIFENESINAmazon.com Services LLCac01ad52-483a-4cce-9279-51ceecada9b92021-07-13WarningsExact identifier
unii: 9D2RTI9KYH
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
Decongestant PE Non DrowsyPHENYLEPHRINE HCLAllegiant Health7a3098b4-381c-4f32-97a7-87b53fd644282021-06-16WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
Mucus Relief Immediate ReleaseGUAIFENESIN 400MGGood Sensee7c68746-7ec0-46cf-b4a3-174fab819b5e2021-05-05WarningsExact identifier
application number: M012
Allergy DyeFreeALLERGY DYEFREEAllegiant Health15736bb8-5a5b-489d-83ad-4cf34ec629562021-04-26WarningsExact identifier
unii: TC2D6JAD40
phenylephrine hydrochloridePHENYLEPHRINE HYDROCHLORIDEGland Pharma Limited6486d284-5189-4000-aa7d-67150e84a7b22021-04-14Warnings, Adverse reactionsExact identifier
unii: 04JA59TNSJ
basic care childrens cough dmDEXTROMETHORPHAN POLISTIREXAmazon.com Services LLC5b7c2306-ad87-48b0-99b7-71427907db0c2021-03-23WarningsExact identifier
unii: 9D2RTI9KYH
basic care cough dmDEXTROMETHORPHAN POLISTIREXAmazon.com Services LLCa0f35883-9dd3-49e7-87ac-ce04561ad6c32021-03-09WarningsExact identifier
unii: 9D2RTI9KYH
Mucus Relief Immediate ReleaseGUAIFENESIN 400MGTopCo Associates, LLC7d91c6ab-d161-42b9-b353-0aa8f59619f82021-01-21WarningsExact identifier
application number: M012
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEProficient Rx LPed9399e2-2be8-4793-99c5-204779c2a4712021-01-01Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
unii: IXA7C9ZN03
PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDEMeitheal Pharmaceuticals Inc.943638b7-527b-4724-a6b7-2018862396d42020-11-30Warnings, Adverse reactionsExact identifier
unii: 04JA59TNSJ
Daytime Cold and FluACETAMINOPHEN 325MG/ DEXTROMETHORPHAN HBR 10MG/ PHENYLEPHRINE HCL 5MGAllegiant Healthbed5f9dc-45ea-4e90-86c6-86599b6f38612020-11-16WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
Nighttime Cold and Flu ReliefACETAMINOPHENAllegiant Healthb97126d7-847d-483e-b3d1-e2b61ab1743f2020-11-11WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Sleep AidDIPHENHYDRAMINE HCLAllegiant Healthec57db48-0f3a-4b12-8633-b45a4366c2692020-11-06WarningsExact identifier
unii: TC2D6JAD40
JEGAMSAN ExtractLONICERA FLOWER, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROMIDEI World Pharmaceutical Co., Ltd.af695c7e-1ad2-ad98-e053-2995a90a2edf2020-09-16WarningsExact identifier
unii: 9D2RTI9KYH
SoCheongRyong Tang ExtractGINGER, CHLORHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEI World Pharmaceutical Co., Ltd.af68634f-eb0a-64e7-e053-2a95a90a5df22020-09-16WarningsExact identifier
unii: 9D2RTI9KYH

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.