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 256 of 256 · 5,119 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
NightTime Cold and FluACETAMINOPHEN,DEXTROMETHORPHAN,DOXYLAMINEVelocity Pharma516fc924-61f0-40ee-9688-3c6da817b4622017-09-11WarningsExact identifier
unii: 9D2RTI9KYH
Walgreens Adult Nighttime Wal Tussin DM Max Maximum StrengthDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWALGREEN CO.385a1e0b-09c5-4f2d-8404-086020e5c8912017-09-07WarningsExact identifier
unii: 9D2RTI9KYH
maximum strength mucus relief severe congestion and coughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDESuperValu Inc.,3bb76952-15d8-4a36-a392-60f62b845f092017-09-01WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
Maximum Strength Mucus Relief Cold,Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCLSUPERVALU INCbe535a56-1b95-424e-8197-566976ef2efa2017-09-01Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
FIND BICHON CLEANSING MASKGLYCERINPioom Cosmetic Co.,ltd50b7db48-7b55-6df4-e054-00144ff88e882017-05-30WarningsExact identifier
unii: PDC6A3C0OX
BRONCOCHEM KIDS ALLERGY CONTROLCHLORPHENIRAMINE MALEATE-DEXTROMETHROPHAN HBRLABORATORIO MAGANCEHM INTERNATIONAL SRL36574266-a6ca-443d-9e1d-85240aabe8a22017-04-10WarningsExact identifier
unii: 9D2RTI9KYH
BRONCOCHEM KIDS COLD AND FLUACETAMINOPHEN-PHENYLEPHRINE HCL-GUAIFENESINLABORATORIO MAGNACHEM INTERNATIONAL SRL523561fb-f6a7-4cde-9be2-bba02e60e2082017-04-06WarningsExact identifier
unii: 04JA59TNSJ
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
BRONCOCHEM ALLERGY CONTROLCHOLPHENIRAMINE MALEATE-PHENYLEPHRINE HCLLABORATORIO MAGNACHEM INTERNATIONAL SRLec5a216c-6827-4de3-8683-ff04e726ff6f2017-03-14WarningsExact identifier
unii: 04JA59TNSJ
Cold MedicineACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLSelder, S.A. de C.V.d2762d9c-e7e7-42b2-a26a-14b2aa0307cb2017-01-25WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
AllergyCHLORPHENIRAMINE MALEATEMarc Glassman, Inc.2051247f-ce64-4cf5-b449-9ca14c43ab862016-12-27WarningsExact identifier
application number: M012
BRONCOCHEM EXPECTORANT IIACETAMINOPHEN-CHLORPHENIRAMINE MALEATE-DEXTROMETHORPHAN HBR-GUAIFENESIN-PHENYLEPHRINE HCLLABORATORIO MAGNACHEM INTERNATIONAL SRLd0426469-9dd1-4bd1-b81e-69d33187daa22016-12-19WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
BRONCOCHEM MAXIMUM COUGHDEXTROMETHORPHAN HBR-GYAIFENESINLABORATORIO MAGNACHEM INTERNATIONAL SRL8aa32b2a-a8be-4f8d-9b1f-eb007bff8e652016-12-19WarningsExact identifier
unii: 9D2RTI9KYH
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEEpic Pharma, LLC15437a72-24e5-4ef2-b1ea-8d8c0acbcd4c2016-11-22WarningsExact identifier
unii: TC2D6JAD40
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEEpic Pharma, LLCa083dec1-d4a7-4573-8a14-f5739d5bf1532016-11-22WarningsExact identifier
unii: TC2D6JAD40
CVS Health Four Actions Nasal DecongestantPHENYLEPHRINE HYDROCHLORIDECVS Pharmacy,Inc.c91b5525-6afb-4fea-afcb-9c45780759752016-09-22WarningsExact identifier
unii: 04JA59TNSJ
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.051f7347-5a76-4664-8fe2-e61b3dfcb0e42014-08-27Exact identifier
unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

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