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 310 of 326 · 6,513 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HEBACETAMINOPHENHEB96b1808f-defa-28cb-e053-2995a90a563b2023-04-12WarningsExact identifier
unii: 362O9ITL9D
butalbital, acetaminophen and caffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINEBryant Ranch Prepack3875c01b-7cd6-4bed-8d4e-c580c55408602023-04-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Arthritis Pain ReliefACETAMINOPHENWINCO FOODS, LLCf45f43da-b994-2bc8-e053-2995a90a93e02023-04-11WarningsExact identifier
unii: 362O9ITL9D
Mucus Relief DMGUAIFENESIN, DEXTROMETHORPHAN HBRStrategic Sourcing Services LLCaf359aca-ec58-47cb-843a-2def1a09a09a2023-04-10WarningsExact identifier
unii: 9D2RTI9KYH
Mucus Relief DMGUAIFENESIN, DEXTROMETHORPHAN HBRStrategic Sourcing Services LLC5eb5f84f-4cb8-4552-b73d-c2b27657fa152023-04-06WarningsExact identifier
unii: 9D2RTI9KYH
DG Health migraine reliefACETAMINOPHEN, ASPIRIN, CAFFEINEDolgencorp, LLCd0e82cac-dfbb-49cb-99c8-560b02fb1a8c2023-04-05WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENProficient Rx LP82b24978-8b15-43a9-b5b0-3313ed2a73c22023-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
SiliceaSILICON DIOXIDEBoiron86d34721-7dfc-bf91-e053-2991aa0a70ae2023-03-27Exact identifier
unii: ETJ7Z6XBU4
Emetrol Chewables Mixed BerrySODIUM CITRATE DIHYDRATEWellSpring Pharmaceutical Corporation4965fab0-828d-4f1d-8d43-a636e0a8c1ea2023-03-23WarningsExact identifier
unii: B22547B95K
Emetrol Chewables OrangeSODIUM CITRATE DIHYDRATEWellSpring Pharmaceutical Corporatione9072f9d-d74c-4e43-bcfe-ee005577df352023-03-23WarningsExact identifier
unii: B22547B95K
equate pain relieverACETAMINOPHEN, IBUPROFENWALMART INC.8e0aaae0-a97d-4b9d-b326-44ef45f3fa0c2023-03-17WarningsExact identifier
unii: 362O9ITL9D
Butalbital, Acetaminophen and CaffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINEGolden State Medical Supply, Inc.ee131bce-863b-b5a1-e053-2a95a90afc792023-03-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Mucinex DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINNavajo Manufacturing Company Inc.4226f394-f85e-45b1-8d5f-7cffb7dd492f2023-03-16WarningsExact identifier
unii: 9D2RTI9KYH
NS SupportBERBERIS VULGARIS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, COLOCYNTHIS, LEDUM PALUSTRE, RANUNCULUS BULBOSUS, AESCULUS HIPPOCASTANUM, CUPRUM ACETICUM, NADIDUM, NATRUM OXALACETICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, ALPHA-LIPOICUM ACIDUM, AMMONIUM MURIATICUM, CARTILAGO SUIS, DISCUS INTERVERTEBRALIS SUIS, PICRICUM ACIDUM, SILICEA, ARGENTUM METALLICUM, CALCAREA PHOSPHORICA, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, GNAPHALIUM POLYCEPHALUM,Dr. Donna Restivo DC807fd9cf-13d1-4173-a6da-180f89b67cf22023-03-15WarningsExact identifier
unii: 91D9GV0Z28
unii: ETJ7Z6XBU4
Advil Allergy and Congestion ReliefCHLORPHENIRAMINE MALEATE, IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDENavajo Manufacturing Company Inc.d40bf078-ee6f-4c64-9c74-e4e770c150bf2023-03-15WarningsExact identifier
unii: V1Q0O9OJ9Z
Calcarea phosphoricaTRIBASIC CALCIUM PHOSPHATEBoiron849c2b13-f918-d87f-e053-2991aa0aa56d2023-03-09Exact identifier
unii: 91D9GV0Z28
basic care migraine reliefACETAMINOPHEN, ASPIRIN, CAFFEINEAmazon.com Services LLCedcc7b4b-1317-4060-b947-8c16effc57422023-02-27WarningsExact identifier
unii: 362O9ITL9D
Calcarea phosphoricaTRIBASIC CALCIUM PHOSPHATEBoiron849ba212-ffb9-0ba6-e053-2a91aa0a701f2023-02-20Exact identifier
unii: 91D9GV0Z28
Saccharum officinaleSUCROSEBoiron6858f374-8549-4b00-e053-2991aa0a5c3c2023-02-20Exact identifier
unii: C151H8M554
SiliceaSILICON DIOXIDEBoiron86d395ec-3c3b-5e5f-e053-2a91aa0a3f9c2023-02-20Exact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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