FDA.reportPublic FDA data

NDC 51316-604 - Acetaminophen, Dextromethorphan HBr, Chlorpheniramine Maleate

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
51316-604
Package NDCs from labels
51316-604-05
Manufacturer
CVS Pharmacy, Inc
Effective date
2025-10-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Acetaminophen, Dextromethorphan HBr - CVS Pharmacy, IncCVS Pharmacy, Inc2025-10-21HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-604-05Acetaminophen, Dextromethorphan HBr, Chlorpheniramine Maleate6 in 1 PACKETPOWDER6 in 1230 mg2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-604ACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE KIT [CVS PHARMACY, INC]1Unmatched20240410_1532ee21-e114-ded7-e063-6294a90ab025.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 308 of 326 · 6,513 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Calcarea phosphoricaTRIBASIC CALCIUM PHOSPHATEBoiron85065cf3-386b-22d5-e053-2a91aa0a72da2023-07-20Exact identifier
unii: 91D9GV0Z28
VACC HCHEPAR SUIS, HISTAMINUM HYDROCHLORICUM, THUJA OCCIDENTALIS, RNA, ECHINACEA (ANGUSTIFOLIA), LEDUM PALUSTRE, MEZEREUM, SILICEA, INFLUENZINUM (2021-2022), ANTIMONIUM TARTARICUM, ARSENICUM ALBUM, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, HYOSCYAMUS NIGER, LAC FELINUM, MERCURIUS SOLUBILIS, NICOTINAMIDUM, SENEGA OFFICINALIS, SPIGELIA ANTHELMIA, SULPHUR, ZINCUM METALLICUMDeseret Biologicals, Inc.c100d87b-4d67-42ef-b7e2-fd3642a104b82023-07-18WarningsExact identifier
unii: ETJ7Z6XBU4
Acetaminophen and Ibuprofen (NSAID)ACETAMINOPHEN AND IBUPROFEN (NSAID)Wal-Mart Stores Inc.e7b36e3c-0e8a-1aeb-e053-2995a90a51a42023-07-17WarningsExact identifier
unii: 362O9ITL9D
Children Pain ReliefCHILDREN PAIN RELIEFAllegiant Health44c90cbe-8ece-4dd8-9ea5-7f8d6f4c00962023-07-17WarningsExact identifier
unii: 362O9ITL9D
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
Butalbital, Acetaminophen, and CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE CAPSULESLannett Company, Inc.4d62259d-a582-4621-b62e-3d5640cadf7c2023-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
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
Leaky Gut FormulaALFALFA, GLYCYRRHIZA GLABRA, ASTACUS FLUVIATILIS, BERBERIS AQUIFOLIUM, LAC DEFLORATUM, NATRUM CARBONICUM, SACCHARUM OFFICINALE, ALOE, FEL TAURI, PANCREAS SUIS, PANCREATINUM, FRAGARIA VESCA, ANTIMONIUM CRUDUM, CARBO VEGETABILIS, EUPHORBIUM OFFICINARUM, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, ZINCUM METALLICUM, COLIBACILLINUM CUM NATRUM MURIATICUM, PROTEUS (VULGARIS)Deseret Biologicals, Inc.8679e9ab-8610-47f1-be0e-66897f99881d2023-07-14WarningsExact identifier
unii: C151H8M554
Calcarea PhosphoricaCALCAREA PHOSPHORICARatis, LLC49e0e934-2374-4209-a168-08daa112e9392023-07-13WarningsExact identifier
unii: 91D9GV0Z28
SiliceaSILICEARatis, LLC8c2b59e1-9936-486c-9a91-153e46f377e62023-07-13WarningsExact identifier
unii: ETJ7Z6XBU4
Dual ActionACETAMINOPHEN, IBUPROFENKROGER COMPANYee0ae5e6-388d-0085-e053-2a95a90add8e2023-07-12WarningsExact identifier
unii: 362O9ITL9D
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
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoironce6a0710-7c28-11e6-86bf-424c583030312023-07-11Exact identifier
unii: ETJ7Z6XBU4
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEA-S Medication Solutionsee227c52-2cd8-4a06-a2de-a257f1f4732a2023-07-11Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
New Hanbang Col CapACETAMINOPHEN, CAFFEINE ANHYDROUS,Lydia Co., Ltd.e9dbbbcd-9ab7-aa10-e053-2995a90acd242023-07-10WarningsExact identifier
unii: 362O9ITL9D
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEQUAGEN PHARMACEUTICALS LLC5f3c7457-6670-4a0d-bdff-c3e0fe91b7c62023-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
NOCOLD-SACETAMINOPHEN, CHLORPHENIRAMINE MALEATELydia Co., Ltd.f2e951c9-afac-7e2e-e053-2a95a90a50202023-07-05WarningsExact identifier
unii: V1Q0O9OJ9Z
unii: 362O9ITL9D
Kidney DrainageSOLIDAGO VIRGAUREA, ASPARAGUS OFFICINALIS, JUNIPERUS COMMUNIS, SABAL SERRULATA, UVA-URSI, BERBERIS VULGARIS, EQUISETUM ARVENSE, URTICA DIOICA, RUBIA TINCTORUM, STAPHYSAGRIA, CANTHARIS, FAGUS SYLVATICA, FLOS, GLANDULA SUPRARENALIS SUIS, HEPAR SULPHURIS CALCAREUM, KIDNEY (SUIS), LARIX DECIDUA, FLOS, MANGANUM METALLICUM, MIMULUS GUTTATUS, FLOS, NITRICUM ACIDUM, RHUS AROMATICA, SILICEA, ULEX EUROPAEUS, FLOS, BENZOICUM ACIDUM, COBALTUM METALLICUMDeseret Biologicals, Inc.4f82e261-6101-48ab-b161-ded5aa41cd852023-06-27WarningsExact identifier
unii: ETJ7Z6XBU4
Grain and Seed AntigensAMARANTH, BAMBOO, BARLEY, BUCKWHEAT, CORN, FLAX SEED, LENTILS, MILLET, MILO, OAT, POPPY SEED, RICE, RYE, SESAME, SOYBEAN, SUGARCANE, SUNFLOWER SEED, WHEAT, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHURBioActive Nutritional, Inc.36ce44a5-e5ac-4eea-b76d-424dcd4e6b072023-06-20WarningsExact identifier
unii: C151H8M554
Arthritis PainACETAMINOPHENBETTER LIVING BRANDS, LLCee84323a-b615-3ec6-e053-2995a90a5a262023-06-15WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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