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 313 of 326 · 6,513 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBRPUBLIX SUPER MARKETS, INC9870b7ee-2bfb-42f5-9762-77d2dd13434a2022-12-06WarningsExact identifier
unii: 9D2RTI9KYH
Guaifenesin and Dextromethorphan Hydrobromide HBRGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDERITE-AID2343f031-d658-498a-b5d1-6dcdb26b3cf02022-12-06WarningsExact identifier
unii: 9D2RTI9KYH
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBRSUN PHARMACEUTICAL INDUSTRIES, INC.06328741-03e3-49cf-ae44-d4c2116e38a32022-12-06WarningsExact identifier
unii: 9D2RTI9KYH
Miranda Castros healing cell salts for bones, hair, nails and teeth Homeopathic CombinationCALCAREA FLUORICA, CALCAREA PHOSPHORICA, SILICEAOHM PHARMA INC.044a7174-f7a3-490f-9cad-01f2665d75752022-12-02WarningsExact identifier
unii: 91D9GV0Z28
unii: ETJ7Z6XBU4
4 Kids Cold and Mucus NighttimeEUPHRASIA STRICTA,SILICON DIOXIDE, RUMEX CRISPUS ROOT, ANEMONE PULSATILLA, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ONION, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA, ARABICA COFFEE BEAN, CALCIUM SULFIDE AND SULFURHyland's Inc.6f7b2585-2f0e-5938-e053-2a91aa0aa9d12022-11-21WarningsExact identifier
unii: ETJ7Z6XBU4
4 Kids Complete Cold and MucusBRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, AND SILICON DIOXIDEHyland's Inc.ef39fe3d-a42d-4baa-9199-91f664feb4322022-11-21WarningsExact identifier
unii: ETJ7Z6XBU4
DG health mucus dmDEXTROMETHORPHAN HBR, GUAIFENESINDolgencorp, LLCadd72ca5-94cd-437f-b30f-6149c08b5f212022-11-14WarningsExact identifier
unii: 9D2RTI9KYH
Sodium Citrate Blood-Pack Units, (PL 146 Plastic)ANTICOAGULANT SODIUM CITRATE SOLUTIONFenwal, Inc.14b238ab-904b-45dc-9eb9-a1074364e0892022-11-07Exact identifier
unii: B22547B95K
DAYTIME-NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLKROGERa2508699-08c0-4a22-e053-2a95a90a8a6d2022-11-02WarningsExact identifier
application number: M012
Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 PlasticANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) SOLUTIONFenwal, Inc.d55cb701-9664-4931-8754-1a8cae68da062022-11-01Exact identifier
unii: XF417D3PSL
unii: B22547B95K
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENProficient Rx LP78933d4a-d78a-43bc-9052-a032901ee0502022-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) SOLUTIONFenwal, Inc.f9d7f1b4-7a77-44f9-8924-10b16008b49d2022-11-01Exact identifier
unii: XF417D3PSL
unii: B22547B95K
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENProficient Rx LP5df7c033-0f31-45bc-8c34-3da45635e66d2022-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 PlasticANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD)Fenwal, Inc.4a08a9ec-46a5-4fcf-80ee-5c33f1a8b7462022-11-01Exact identifier
unii: XF417D3PSL
unii: B22547B95K
Mucus Relief DMGUAIFENESIN, DEXTROMETHORPHAN HBRCare One (Retail Business Services, LLC.)eb3ef974-4e79-4065-a8c9-9307092da6b32022-10-21WarningsExact identifier
unii: 9D2RTI9KYH
Mucus Relief DMGUAIFENESIN, DEXTROMETHORPHAN HBRCare One (Retail Business Services, LLC.)93658f3c-1f57-41b5-acdc-ee7ee47656a32022-10-21WarningsExact identifier
unii: 9D2RTI9KYH
Mucus Relief DM Extended Release CapletsGUAIFENESIN, DEXTROMETHORPHAN HBRCardinal Health (Leader) 7000004af43e6-6276-42ec-a902-3de22bc9fdea2022-10-20WarningsExact identifier
unii: 9D2RTI9KYH
Equate 8HR Arthritis Pain ReliefACETAMINOPHENWal-Mart Stores Incca7f0f68-2862-4265-bf4a-3a89994b4d6b2022-10-13WarningsExact identifier
unii: 362O9ITL9D
Arthritis Pain ReliefACETAMINOPHENTOPCO ASSOCIATES LLCe60aa992-f5f7-3506-e053-2995a90a7abd2022-10-04WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENProficient Rx LPe6711f26-a01d-43e8-882a-d58561e4b67f2022-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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