FDA.reportPublic FDA data

NDC 51316-983-01 - Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr

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
51316-983
Requested NDC
51316-983-01
Package NDCs from labels
51316-983-01
Manufacturer
CVS Pharmacy, Inc
Effective date
2025-09-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DEXTROMETHORPHAN HYDROBROMIDE - CVS Pharmacy, IncCVS Pharmacy, Inc2025-09-04HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-983-01Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr10 in 1 BLISTER PACKTABLET, FILM COATED20 in 40500 mg2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-983ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR KIT [CVS PHARMACY, INC]1Unmatched20250403_31aa77e0-cfdb-57a8-e063-6394a90af98c.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 95 of 392 · 7,835 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mixed Berry Sore Throat and Cough lozengeDEXTROMETHORPHAN HYDROBROMIDEMeijer Distribution, Inc.304ff4db-201a-60a4-e054-00144ff8d46c2026-02-02WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Allergy Relief Plus CongestionDIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWalgreen Company38d91107-d95c-40f2-a27e-561f951e519d2026-02-02WarningsExact identifier
application number: M012
Menstrual ReliefACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATEDOLGENCORP, LLC89eb8196-54c6-4e30-8655-502cc4313c8a2026-02-02WarningsExact identifier
unii: 362O9ITL9D
Nighttime Pain Reliever plus Sleep AidACETAMINOPHEN, DIPHENHYDRAMINE HCLWALMART INC.8dd85a6b-507c-4502-9e55-a40bdf21d3792026-02-02WarningsExact identifier
unii: 362O9ITL9D
Pain RelieverACETAMINOPHENRite Aid Corporation9a647967-f0c6-466e-be70-34fd3de0a8032026-02-02WarningsExact identifier
unii: 362O9ITL9D
Tussin SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINHyVee Inc85252999-3463-45fe-b4a9-7a97960b41b12026-02-02WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Pain Reliever Extra StrengthACETAMINOPHENWal-Mart Stores Inc72365264-f9c4-49f0-be64-73d95817d3582026-02-02WarningsExact identifier
unii: 362O9ITL9D
Amazon Basics Cherry Cough Drops 30ctMENTHOLAmazon3e74e209-c9c9-3979-e063-6294a90afcfa2026-02-01WarningsExact identifier
application number: M012
Amazon Basics Honey Lemon Cough Drops 30ctMENTHOLAmazon3e75838b-e1c9-2d42-e063-6294a90aab822026-02-01WarningsExact identifier
application number: M012
Acetaminophen 325mgACETAMINOPHENMarlex Pharmaceuticals Inc4a18168c-dd36-8280-e063-6394a90a7e102026-02-01WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENMarlex Pharmaceuticals Inc4a183b7d-3a1e-5557-e063-6294a90a54932026-02-01WarningsExact identifier
unii: 362O9ITL9D
cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEHyVee Inc5110526f-51fd-401e-ba52-520674d34f372026-02-01WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLAmazon.com Service LLC673996ab-6e57-4feb-8af3-d8b474741a8d2026-01-30Warnings, Adverse reactionsExact identifier
application number: M012
Reef safe unscented SPF 50 mineral sunscreen 01TITANIUM DIOXIDE, ZINC OXIDECosmuses Cosmetics (Ningbo) Co., Ltd.49a77ad4-508c-9617-e063-6394a90a56232026-01-30WarningsExact identifier
unii: 15FIX9V2JP
JOSIE MARAN ARGAN SUN MILK MINERAL SUNSCREEN BROAD SPECTRUM SPF 33TITANIUM DIOXIDE AND ZINC OXIDECosmetic Solutions LLCd65ae1c9-dff5-4612-b8be-fa59bba03b812026-01-30WarningsExact identifier
unii: 15FIX9V2JP
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBRAurohealth LLC88bc399a-2b71-45a7-bdfb-226ff1df05362026-01-30WarningsExact identifier
unii: 9D2RTI9KYH
Migraine ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEFamily Dollar (FAMILY WELLNESS)bfcffa70-94a9-43de-9f22-4ed6a71c0a8d2026-01-29WarningsExact identifier
unii: 362O9ITL9D
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEStrategic Sourcing Services, LLC1d6c23d7-d1dc-4cba-8600-5762c18a0e272026-01-29WarningsExact identifier
application number: M012
EXTRA STRENGTH PAIN RELEIFACETAMINOPHENStrategic Sourcing Services, LLC0392db17-c4f3-424b-9dee-549fc5df61c52026-01-29WarningsExact identifier
unii: 362O9ITL9D
Regular Strength Pain RelieverACETAMINOPHENStrategic Sourcing Services, LLC959db1b0-2d9f-4857-b475-0fa0273652122026-01-29WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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