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 262 of 332 · 6,623 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FocusGINKGO BILOBA, ALPHA-KETOGLUTARICUM ACIDUM, IODIUM, PHOSPHORUS, SARCOLACTICUM ACID, SACCHARUM OFFICINALE, ADENOSINUM CYCLOPHOSPHORICUM, CEREBRUM SUIS, HYPOTHALAMUS SUIS, SILICEA, ADRENALINUM, AMBRA GRISEA, CARBONEUM SULPHURATUM, TARENTULA HISPANA, AETHUSA CYNAPIUM, BARYTA CARBONICA, HELLEBORUS NIGER, VERATRUM ALBUM, CANDIDA ALBICANS, HYOSCYAMUS NIGERDeseret Biologicals, Inc.e77857b8-be67-4041-8c8d-9772f17c6d062024-09-11WarningsExact identifier
unii: C151H8M554
unii: ETJ7Z6XBU4
MammaryplexECHINACEA (ANGUSTIFOLIA), MYRRHA, TRIGONELLA FOENUM-GRAECUM, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, LYMPH (SUIS), SPLEEN (SUIS), BRYONIA (ALBA), CONIUM MACULATUM, LAC CANINUM, LACHESIS MUTUS, SILICEA, BUFO RANA, MAMMARY GLAND (BOVINE)BioActive Nutritional, Inc.9c9ed6f6-8690-4fbd-8691-26dd577014a82024-09-11WarningsExact identifier
unii: ETJ7Z6XBU4
PMS ReliefAGNUS CASTUS, CIMICIFUGA RACEMOSA, KALI CARBONICUM, LYCOPODIUM CLAVATUM, SACCHARUM OFFICINALE, THYROIDINUM (BOVINE), HYPOTHALAMUS SUIS, ARISTOLOCHIA CLEMATITIS, FOLLICULINUM, AURUM SULPHURATUM, CANDIDA ALBICANS, COCCULUS INDICUS, CONIUM MACULATUM, CYCLAMEN EUROPAEUM, ELAPS CORALLINUS, LAC CANINUM, LACHESIS MUTUS, MAGNESIA CARBONICA, PULSATILLA (PRATENSIS), STANNUM METALLICUMDeseret Biologicals, Inc.ca073beb-330d-406c-9bf5-196a89f3ab582024-09-11WarningsExact identifier
unii: C151H8M554
Acetaminophen and Diphenhydramine hydrochlorideACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANYb9b86755-63ad-e25a-e053-2995a90ad7472024-09-10WarningsExact identifier
unii: 362O9ITL9D
Parents Choice Infants Pain and FeverACETAMINOPHENWal-Mart Stores Inc30a51b90-a565-4e38-82ee-b5af297629772024-09-10WarningsExact identifier
unii: 362O9ITL9D
signature care infants pain reliefACETAMINOPHENSafeway236df05a-cf11-42f3-a347-b54f5113680c2024-09-10WarningsExact identifier
unii: 362O9ITL9D
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINESOLCO HEALTHCARE US, LLC5c9c3407-212a-4ae9-a574-2b0c53f3c5eb2024-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
TYLENOL 8 HR ARTHRITIS PAINACETAMINOPHENKenvue Brands LLC0391963c-022d-1433-e063-6294a90aac902024-09-09WarningsExact identifier
unii: 362O9ITL9D
pain reliefACETAMINOPHENMeijer Distribution Incd2759fa6-59cd-417e-8761-d2b129aad8b82024-09-09WarningsExact identifier
unii: 362O9ITL9D
Good Sense NasalOXYMETAZOLINE HYDROCHLORIDEL. Perrigo Company276d7d3c-c4a7-4754-8845-c38f85aac5f72024-09-08WarningsExact identifier
application number: M012
Haben Herb F CapACETAMINOPHEN, DRIED CINNAMON EXTRACTLydia Co., Ltd.21a5c7c4-5aa3-9337-e063-6394a90a30802024-09-08WarningsExact identifier
unii: 362O9ITL9D
foster and thrive nasalOXYMETAZOLINE HYDROCHLORIDEStrategic Sourcing Services LLC4ff5a4ae-9649-4a6d-a5f8-ca23efbbb4792024-09-08WarningsExact identifier
application number: M012
equate nasal originalOXYMETAZOLINE HYDROCHLORIDEWal-Mart Stores Inc7e40c9b8-e0b5-448a-a674-72388fbab1892024-09-08WarningsExact identifier
application number: M012
Leader Preservative-Free Ultra Lubricating Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCardinal Health2a2aa620-ca63-4698-88fd-fc263b8fa0d12024-09-07WarningsExact identifier
unii: 6DC9Q167V3
Anefrin Nasal OriginalOXYMETAZOLINE HYDROCHLORIDEWalgreen Company85b442dc-1703-4fef-948a-fad7cbe9f2242024-09-07WarningsExact identifier
application number: M012
equaline nasalOXYMETAZOLINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFI07e0328e-1912-4f25-9e1e-9482d4665be02024-09-07WarningsExact identifier
application number: M012
Benadryl Allergy EXTRA STRENGTHDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLCdd0a8069-18d8-5696-e053-2995a90a2f222024-09-06WarningsExact identifier
application number: M012
Guaifenesin and Codeine PhosphateGUAIFENESIN AND CODEINE PHOSPHATEPAI Holdings, LLC88d0994c-4270-4408-8837-bd97510b21182024-09-06WarningsExact identifier
application number: M012
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack2a485efe-a87c-4c55-9e17-7891b2fffb832024-09-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
M-PAPACETAMINOPHENBryant Ranch Prepackd344479b-80c1-4592-acc8-3f12690c839c2024-09-06WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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