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 189 of 334 · 6,679 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EXTRA STRENGHT HEADACHE RELIEFACETAMINOPHEN, ASPIRIN, CAFFEINELil' Drug Store Products, Inc.ec04eb5d-96c0-ddb4-e053-2a95a90a4a922025-07-02WarningsExact identifier
unii: 362O9ITL9D
FeverAllACETAMINOPHENSun Pharmaceutical Industries, Inc.8970b91b-5f3c-4764-9e23-25dcb398d0a72025-07-02WarningsExact identifier
unii: 362O9ITL9D
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESINDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINKJD Pharma Private Limitedb109249a-a0be-41bd-b6ce-ef621b588ddc2025-07-02WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Childrens Pain and FeverACETAMINOPHENMeijer Distribution Inc11c9712d-c3b2-49cd-9c2b-0f57190c954e2025-07-02WarningsExact identifier
unii: 362O9ITL9D
Pain and Fever ChildrensACETAMINOPHENCVS Pharmacyf6bbce1c-9790-4ca4-847f-579c594ffe0b2025-07-01WarningsExact identifier
unii: 362O9ITL9D
Daytime Mucus Relief Severe Congestion and Cough and Nighttime Cold and Flu Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLCVS Pharmacy91c803c8-6cf8-4ff6-b376-ea6d65f9f2272025-07-01WarningsExact identifier
application number: M012
Mucus Relief DM Maximum StrengthGUAIFENESIN, DEXTROMETHORPHAN HBRChain Drug Consortium, LLCd6aae1a1-0ab9-4b26-9f62-b8761014bb352025-06-30WarningsExact identifier
unii: 9D2RTI9KYH
Pain RelieverACETAMINOPHENWALGREENS07d2e322-2465-79e5-e063-6294a90a5ea42025-06-30WarningsExact identifier
unii: 362O9ITL9D
WALGREENS Dye Free Chidrens Allergy ChewsDIPHENHYDRAMINE HCLWALGREENS CO.cc2fdc6b-8319-47c8-b036-37dbd65d58332025-06-30WarningsExact identifier
application number: M012
WALGREENS Dye Free Chidrens Allergy ChewsDIPHENHYDRAMINE HCLWALGREENS CO.91c369b0-8620-4764-a85d-a86402d9489c2025-06-30WarningsExact identifier
application number: M012
Arthritis PainACETAMINOPHENDISCOUNT DRUG MART973bcf75-8c45-ea16-e053-2a95a90aad632025-06-30WarningsExact identifier
unii: 362O9ITL9D
Pain ReliefACETAMINOPHENDISCOUNT DRUG MART66c0cf26-357b-4722-9100-3b86d507a8cd2025-06-30WarningsExact identifier
unii: 362O9ITL9D
Arnica Calendula WoundARNICA CALENDULA WOUNDUriel Pharmacy, Inc38cfd292-4dbd-2caf-e063-6394a90a05272025-06-30WarningsExact identifier
unii: ETJ7Z6XBU4
BacAPIS MELLIFERA, ARSENIC TRIOXIDE, ATROPA BELLADONNA, MATRICARIA CHAMOMILLA FLOWERING TOP OIL, LACHESIS MUTA VENOM, MERCURIUS SOLUBILIS, PULSATILLA VULGARIS WHOLE, TOXICODENDRON PUBESCENS LEAF, AND SILICON DIOXIDEZorex7ae38e0c-8e74-4fd5-8605-45e424a84d012025-06-30WarningsExact identifier
unii: ETJ7Z6XBU4
Allergy Relief Diphenhydramine HCl 25mg SoftGelDIPHENHYDRAMINE HYDROCHLORIDEPioneer Life Sciences, LLCbb9a82b1-ea7a-4d10-bc00-05013e83c4d32025-06-30WarningsExact identifier
application number: M012
Daytime and Nighttime Cherry Cold and FluDAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEBETTER LIVING BRANDS, LLC202f0661-461c-0333-e063-6294a90a96b52025-06-28WarningsExact identifier
application number: M012
good sense pain relief arthritis painACETAMINOPHENASCLEMED USA INC.2315ec07-e5b8-4332-8bc2-4e28e88892f32025-06-27WarningsExact identifier
unii: 362O9ITL9D
Mucus Relief DM Extended Release CapletsGUAIFENESIN, DEXTROMETHORPHAN HBRATLANTIC BIOLOGICALS CORP.308f50dd-e8d6-0264-e063-6394a90afa682025-06-27WarningsExact identifier
unii: 9D2RTI9KYH
Bambusa AurumBAMBUSA AURUMUriel Pharmacy Inc.43f3dd30-701f-4fa4-9743-d10051c6e6d42025-06-27WarningsExact identifier
unii: ETJ7Z6XBU4
InterSolPLATELET ADDITIVE 3Fenwal, Inc.17dec820-1b57-4ac9-82a8-419cab664a2f2025-06-27Warnings, Adverse reactionsExact identifier
unii: B22547B95K

Reported adverse events (FAERS/openFDA)#

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