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 253 of 256 · 5,119 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PEDOXAN ExtractCITRUS UNSHIU PEEL, SAPOSHNIKOVIA ROOT, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEI World Pharmaceutical Co., Ltd.af69d604-180c-702f-e053-2a95a90a2ae42020-09-16WarningsExact identifier
unii: 9D2RTI9KYH
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDESagent Pharmaceuticalsb3ff0d1d-6f3f-4e3c-9407-6f3bf3a61e7d2020-07-10Warnings, Adverse reactionsExact identifier
unii: 04JA59TNSJ
equate cough dmDEXTROMETHORPHAN POLISTIREXWal-Mart Stores Inc5f72c4ad-1c30-41ea-b39c-7f4bb3deced62020-07-08WarningsExact identifier
unii: 9D2RTI9KYH
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.ee831456-5962-4d5e-ad0c-69ab858604532020-06-03Exact identifier
unii: XF417D3PSL
Cough DMDEXTROMETHORPHAN POLISTIREXCVS Pharmacy956f0bd4-3266-4754-9bd2-ac480e3bcbce2020-05-27WarningsExact identifier
unii: 9D2RTI9KYH
IBUPROFEN, DIPHENHYDRAMINE HCLIBUPROFEN, DIPHENHYDRAMINE HCLRite Aid Corporationa35f68f3-c7f8-a55f-e053-2a95a90a90472020-04-15WarningsExact identifier
unii: TC2D6JAD40
SorbitolSORBITOLBaxter Healthcare Corporationaea0b5a1-444b-4330-a3ce-26485dbbfe752019-12-31Warnings, Adverse reactionsExact identifier
unii: 506T60A25R
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
RenacidinCITRIC ACID, GLUCONOLACTONE AND MAGNESIUM CARBONATEUnited-Guardian, Inc.13a9bbba-db21-4cba-991c-5d8afaf2ed742019-12-17Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
Cold and AllergyPHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATEAllegiant Health7af63769-fa56-4f1f-a2ad-5b4c108c8e4f2019-12-12WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
CareOne Cough DMDEXTROMETHORPHAN POLISTIREXAmerican Sales Company42f67a3c-8cd7-44a6-8e54-08fb8449e8d72019-12-09WarningsExact identifier
unii: 9D2RTI9KYH
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.e41adb4e-06fb-4141-ba55-50b043f3c9da2019-11-19Exact identifier
unii: XF417D3PSL
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.14445dfd-6041-40cd-a043-3f4da6bcb9c12019-11-18Exact identifier
unii: XF417D3PSL
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.2557199a-5f60-49d8-b093-1e07002112432019-11-18Exact identifier
unii: XF417D3PSL
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.794f724c-87f0-49c1-9b26-c9e4919783132019-11-18Exact identifier
unii: XF417D3PSL
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.5c7d3287-883a-459b-9214-074a583c8a592019-11-18Exact identifier
unii: XF417D3PSL
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.448a1dc5-7a98-4b2f-82af-4b92de05cfc32019-11-18Exact identifier
unii: XF417D3PSL
Discount Drug Mart Regular Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEDiscount Drug Mart8748c31d-8258-0357-e053-2a95a90a9c222019-04-24WarningsExact identifier
unii: TC2D6JAD40
Best Choice Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATEValu Merchandisers873591ef-16cb-ab90-e053-2991aa0a865d2019-04-23WarningsExact identifier
unii: TC2D6JAD40

Reported adverse events (FAERS/openFDA)#

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