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 255 of 256 · 5,119 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nightime Sleep AidDIPHENHYDRAMINEVelocity Pharma9c44e54f-d8bc-4451-8382-40d2e8e03b422018-05-21WarningsExact identifier
unii: TC2D6JAD40
Pain Relief PMACETAMINOPHEN PMVelocity Pharmac1c1de91-6a54-4d91-93a9-b6be6d7c7dfb2018-05-14WarningsExact identifier
unii: TC2D6JAD40
AllergyDIPHENHYDRAMINE HYDROCHLORIDEVelocity Pharma LLC73e4f21c-e5ec-42c9-9ec8-1184798570572018-05-14WarningsExact identifier
unii: TC2D6JAD40
Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEVelocity Pharma LLC035454a1-d23b-4faf-8fac-a59fc77ce18c2018-05-14WarningsExact identifier
unii: TC2D6JAD40
Xyralid HemorrhoidalHEMORRHOIDAL SUPPOSITORIESInnovus Pharmaceuticals, Inc.8a885822-42e7-44e0-82d6-fa967123866e2018-05-03WarningsExact identifier
unii: 04JA59TNSJ
DEXTROMETHORPHAN HYDROBROMIDE, Guaifenesin, and PHENYLEPHRINE HYDROCHLORIDEDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEWestminster Pharmaceuticals, LLCa58bfb14-28f9-4425-a5a5-aaff4847c9792018-03-14WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
Childrens Multi-symptom Cold and Fever LiquidACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWal-Mart Stores, Inc.7bf30c75-e867-4a2f-a481-702d7aa96c232018-01-08WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
CVS Health Childrens Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy,Inc.dbd8c221-8409-4851-a6b4-c9f5e8e346e72017-12-30WarningsExact identifier
unii: TC2D6JAD40
Tukol ADEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USA, Inc.651f0d7c-c76b-434d-95fd-427609b40b462017-12-28WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
ACETAMINOPHEN PMACETAMINOPHEN PMAdvance Pharmaceutical Inc.b172226e-8f2a-4d9c-b7c7-dd737b90463a2017-12-22WarningsExact identifier
unii: TC2D6JAD40
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEAdvance Pharmaceutical Inc.e1275cf5-94a7-4a15-be5c-81af95f8dd242017-12-22WarningsExact identifier
unii: TC2D6JAD40
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEAdvance Pharmaceutical Inc.c80f9a4c-1055-45d2-8fde-5b57fad3c82a2017-12-22WarningsExact identifier
unii: TC2D6JAD40
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEAdvance Pharmaceutical Inc.4e66c626-607f-4558-ab2e-2dd9a25f7be42017-12-22WarningsExact identifier
unii: TC2D6JAD40
Chlorpheniramine maleate 4mgCHLORPHENIRAMINE MALEATE 4MGAthlete's Needs, Inc.4d974959-25fc-4707-9b72-9afbf47b76f12017-11-14WarningsExact identifier
application number: M012
Homeoplex DGLYCERINUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (SUIS), LITHIUM CARBONICUM, THYROIDINUM (SUIS), SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM,Supplement Clinic, LLC.cd6b48ab-3566-484d-8deb-15ef6f8e7e8f2017-11-01WarningsExact identifier
unii: PDC6A3C0OX
unii: 506T60A25R
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDERichmond Pharmaceuticals, Inc.ab67121e-2477-47dd-a7ec-114453df3fd42017-10-30WarningsExact identifier
unii: TC2D6JAD40
Mucus Relief Cough and Congestion DMGUAIFENESIN AND DEXTROMETHORPHAN HBRRichmond Pharmaceuticals, Inc59b00858-e5c9-420a-bc7e-46953722cde62017-10-30WarningsExact identifier
unii: 9D2RTI9KYH
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEAdvance Pharmaceutical Inc.d1f51b7b-da65-4637-8199-f7d59e6dd1c12017-10-30WarningsExact identifier
unii: TC2D6JAD40
Mucus Relief Cough and Congestion DMGUAIFENESIN AND DEXTROMETHORPHAN HBRAdvance Pharmaceutical Inc.e507a84a-59d5-47f2-a2df-f342e4b093b42017-10-30WarningsExact identifier
unii: 9D2RTI9KYH
CVS Health Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy,Inc.03f521f4-d35f-4f66-b3ad-7e58a244eb932017-10-18WarningsExact identifier
unii: TC2D6JAD40

Reported adverse events (FAERS/openFDA)#

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