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 169 of 334 · 6,679 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cabinet Pain Reliever and Fever Reducer Refill AcetaminophenACETAMINOPHENCabinet Health P.B.C.2744f082-adfd-4dfc-a87d-ed8c0d84a4472025-10-01WarningsExact identifier
unii: 362O9ITL9D
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDEInvaTech Pharma Solutions LLCb8d360fa-0d80-f6a8-e053-2a95a90a8bd42025-10-01Exact identifier
application number: M012
MUCINEX DMGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEA-S Medication Solutionsfcaf1df9-b396-44f2-94ce-e46e80aba66c2025-10-01WarningsExact identifier
unii: 9D2RTI9KYH
LEADER TUSSIN CFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCardinal Health 110, LLC. dba Leaderf4ffe87b-0a62-44ac-b84a-08cf77cda7f52025-10-01WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 362O9ITL9D
ACETAMINOPHEN 325 MGACETAMINOPHENProficient Rx LP6794830a-7856-464d-84be-c8b253cf41ac2025-10-01WarningsExact identifier
unii: 362O9ITL9D
Nasal Spray, 1oz, 24/7 Life by 7-ElevenOXYMETAZOLINE HCL NASAL SOLUTION 0.05%Lil' Drug Store Products, Inc.3e781417-9ffc-f2c9-e063-6294a90a72052025-09-30WarningsExact identifier
application number: M012
Original Extra Strong All Natural Fishermans Friend Menthol Cough SuppressantMENTHOLLofthouse of Fleetwood, Ltd.d8f4a65b-cf2c-4424-b27f-e3e0ffadd9cf2025-09-30WarningsExact identifier
application number: M012
8 hr arthritis painACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED68e5b8a7-17ca-4a29-9f0c-7350fcf659282025-09-30WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen gelcapsACETAMINOPHENTARGET CORPORATION2ea1931e-334e-a551-e063-6394a90a03b92025-09-29WarningsExact identifier
unii: 362O9ITL9D
acetaminophenACETAMINOPHENTARGET CORPORATION8ed1d1f5-fe4a-5fd8-e053-2a95a90a90fb2025-09-29WarningsExact identifier
unii: 362O9ITL9D
Giltuss Honey Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINDextrum Laboratories, Inc3ff240ba-90b2-4c17-e063-6394a90ac56f2025-09-29WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Pain Relief PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDETopCo Associates LLC3b672ec7-8658-4b43-a79d-094ac8bc69042025-09-29WarningsExact identifier
unii: 362O9ITL9D
DometussCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDextrum Laboratories, Inc3fcace53-a81f-e774-e063-6294a90a32fa2025-09-27WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: V1Q0O9OJ9Z
kirkland signature acetaminophen adult extra strengthACETAMINOPHENCostco Wholesale Companya9979167-1a82-47d7-9602-2865f9bdd6282025-09-27WarningsExact identifier
unii: 362O9ITL9D
nitetime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLMeijer Distribution Incf6a3680a-3ac6-4fd4-be52-ce29064c4aa12025-09-26WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Cough DMDEXTROMETHORPHAN POLISTIREXPublix Super Markets Inc5a71cad4-8816-47f4-840c-27765d377f0a2025-09-26WarningsExact identifier
unii: 9D2RTI9KYH
Cloveden Vegan Whitening ToothSILICA, HYDROGEN PEROXIDE, TOCOPHERYL ACETATEDONG IL PHARMS CO.,LTD3fb16579-7cf1-873a-e063-6294a90a9ac12025-09-26WarningsExact identifier
unii: ETJ7Z6XBU4
No Drip Severe Nasal MistOXYMETAZOLINE SPRAYCVS Health9d9f6c03-0ae1-4f3b-80cd-b23b7c4bdae52025-09-26WarningsExact identifier
application number: M012
Cough DMDEXTROMETHORPHAN POLISTIREXMeijer Distribution Incfb6fce1e-2dea-485c-be18-c6764454fe252025-09-26WarningsExact identifier
unii: 9D2RTI9KYH
Giltuss Allergy PlusCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEDextrum Laboratories Inc.3fa0b3be-2124-ed1d-e063-6294a90aaf482025-09-25WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: V1Q0O9OJ9Z

Reported adverse events (FAERS/openFDA)#

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