FDA.reportPublic FDA data

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 246 of 256 · 5,119 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anubis Barcelona New EvenLACTIC ACID, CITRIC ACID, GLYCOLIC ACIDANUBIS COSMETICS SLeaeeb6e0-5322-20c4-e053-2995a90a9fd92023-09-01WarningsExact identifier
unii: 6DC9Q167V3
unii: 059QF0KO0R
unii: H3R47K3TBD
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEBryant Ranch Prepack51c95c28-8979-4b75-b1d6-8568751065872023-08-16Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
unii: IXA7C9ZN03
Promethazine Hydrochloride and Dextromethorphan Hydrobromide OralPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORALA-S Medication Solutions9c3e0e87-b2f5-4a09-9db8-6d088d2a5f252023-08-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
equaline mucus dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINUnited Natural Foods, Inc. dba UNFI1db69578-2331-4fce-91a4-95c54cb7dc072023-08-07WarningsExact identifier
unii: 9D2RTI9KYH
Equaline Mucus DMDEXTROMETHORPHAN HBR, GUAIFENESINUnited Natural Foods, Inc. dba UNFI04334889-f75e-4a19-a8b4-47b8db18b9aa2023-08-02WarningsExact identifier
unii: 9D2RTI9KYH
Mucinex DM Maximum StrengthGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEA-S Medication Solutions104b29ed-a377-4436-8e24-413c63579f2e2023-07-27WarningsExact identifier
unii: 9D2RTI9KYH
equaline cough dmDEXTROMETHORPHAN POLISTIREXUnited Natural Foods, Inc. dba UNFI16de32bb-1d02-470b-82b6-9b4366e198172023-07-24WarningsExact identifier
unii: 9D2RTI9KYH
Liverex IGINKGO BILOBA, FEL TAURI, GALLBLADDER (SUIS), HEPAR SUIS), THYROIDINUM (SUIS), GERMANIUM SESQUIOXIDE, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALICUM ACIDUM, MANGANUM METALLICUM, PYRUVIC ACID, SUCCINICUM ACIDUM, NAPHTHOCHINONUM, ARSENICUM METALLICUM, SULPHUR, ACONITICUM ACIDUM, CIS, LYCOPODIUM CLAVATUM, NATRUM OXALACETICUM, PHOSPHORUSEnergique, Inc.1c23c489-0a43-4736-a30a-0ae02c09fb452023-07-21WarningsExact identifier
unii: XF417D3PSL
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEArmas Pharmaceuticals Inc.c1cd6138-ca31-4bb5-ae47-2d80d4d54f9d2023-07-20Warnings, Adverse reactionsExact identifier
unii: TC2D6JAD40
PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDESomerset Therapeutics, LLC18b65b44-fdd1-4385-b6f8-cf3cbdc8d0e62023-07-17Warnings, Adverse reactionsExact identifier
unii: 04JA59TNSJ
REFL HSADENOSINUM TRIPHOSPHORICUM DINATRUM, NADIDUM, ARGENTUM NITRICUM, IPECACUANHA, ROBINIA PSEUDOACACIA, SULPHUR, ORIGANUM VULGARE, DUODENUM (SUIS), ESOPHAGUS (SUIS), FUNICULUS UMBILICALIS SUIS, STOMACH (SUIS), NUX VOMICA, COUMARINUM, ERYTHRAEA CENTAURIUM, PANCREATINUM, MURIATICUM ACIDUM, CITRICUM ACIDUM, FORMICUM ACIDUM, SARCOLACTICUM ACIDUM, COENZYME A, PROTEUS (MORGANI)Deseret Biologicals, Inc.2fe2d3c1-1829-4a33-be8e-2bad52546f362023-07-17WarningsExact identifier
unii: XF417D3PSL
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHURBioActive Nutritional3382df85-3ec5-4371-830e-4ed345b8f51b2023-07-14WarningsExact identifier
unii: 6DC9Q167V3
PneumotoxTRITICUM AESTIVUM, ALFALFA, ARNICA MONTANA, ASCLEPIAS TUBEROSA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, FUCUS VESICULOSUS, HORDEUM VULGARE, IODIUM, NASTURTIUM AQUATICUM, PLANTAGO MAJOR, RAPHANUS SATIVUS, TRIFOLIUM PRATENSE, TRIGONELLA FOENUM-GRAECUM, SYMPHYTUM OFFICINALE, LUNG (SUIS), ORYZA SATIVA, SILICEA, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, NATRUM MURIATICUM, NITRICUM ACIDUM,BioActive Nutritional, Inc.f8846fb1-92e5-4f8e-b3b3-bc620df90a622023-07-12WarningsExact identifier
unii: 6DC9Q167V3
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEA-S Medication Solutionsee227c52-2cd8-4a06-a2de-a257f1f4732a2023-07-11Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDEBE Pharmaceuticals Inc.fb069778-d16e-40f9-9c02-5496adfcb5d22023-07-10Warnings, Adverse reactionsExact identifier
unii: 04JA59TNSJ
Sleep AidSLEEP AIDBetter Living Brands LLC2b730fa5-47f9-468d-86ed-0d49d9cd8dc42023-07-06WarningsExact identifier
unii: TC2D6JAD40
SODIUM PHENYLACETATE AND SODIUM BENZOATESODIUM PHENYLACETATE AND SODIUM BENZOATEMAIA PHARMACEUTICALS, INC3529be10-0004-4628-9ca1-67a8acd86b512023-07-05Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDEParagon BioTeck, Inc.a4d3fe20-f063-11e0-ac29-0002a5d5c51b2023-06-29Warnings, Adverse reactionsExact identifier
unii: 04JA59TNSJ
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEA-S Medication Solutions440d0554-995c-47df-b9f6-f3e3ce2e35e02023-06-06Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
unii: IXA7C9ZN03
LY-COANGELICA ARCHANGELICA, KALI MURIATICUM, YUCCA FILAMENTOSA, CARTILAGO SUIS, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, RHUS TOX, CAUSTICUM, MAGNESIA PHOSPHORICA, MANGANUM METALLICUM, OXALICUM ACIDUM, ARNICA MONTANA, BORRELIA BURGDORFERI NOSODE, LATRODECTUS MACTANS, CITRICUM ACIDUM, CYTOMEGALOVIRUS NOSODE, RICKETTSIA NOSODE (RICKETTSIA PROWAZEKII), CHLAMYDIA TRACHOMATIS, LEDUM PALUSTREBhp Holdings, Inc.47140966-5b49-432d-bf35-bcae14f420822023-06-01WarningsExact identifier
unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

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