FDA.reportPublic FDA data

NDC 51316-451 - 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
51316-451
Package NDCs from labels
51316-451-01
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
51316-451-01Acetaminophen, 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
51316-451ACETAMINOPHEN, 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 74 of 398 · 7,941 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepacka2e33ea3-941f-4810-b008-abbb109730a92026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack79c3af61-19e7-40e5-bd20-2cea52f0bd3a2026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
EltaMD Skincare UV AOX Elements SPF50 TintedTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc2c74209d-9b88-4c32-ad42-cd6de16c1fef2026-04-03WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV Restore TintedTITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENCP Skin Health Group, Inc4fc18856-01b3-43ed-9e1b-b4394e31aa3c2026-04-03WarningsExact identifier
unii: 15FIX9V2JP
Allergy ReliefCHLORPHENIRAMINE MALEATEStrategic Sourcing Services LLCc9fa8d93-d9d6-4206-a13d-32b9e7555e7f2026-04-02WarningsExact identifier
application number: M012
unii: V1Q0O9OJ9Z
Sinus Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLKroger Company6aaed3fe-ce35-4533-aea4-80096ce8e57a2026-04-02WarningsExact identifier
application number: M012
unii: 362O9ITL9D
Childrens AcetaminophenACETAMINOPHENGrocery Outlet, Inc.44de6f5a-0b5c-6c28-e063-6394a90a7e0b2026-04-02WarningsExact identifier
unii: 362O9ITL9D
Sunscreen for baby SPF50plusOCTOCRYLENE,ETHYLHEXYL METHOXYCINNAMATE,TITANIUM DIOXIDE,ETHYLHEXYL SALICYLATEGuangzhou Senmai Biotechnology Co., Ltd.1cb7fbca-0874-ae53-e063-6294a90ab42a2026-04-02WarningsExact identifier
unii: 15FIX9V2JP
TiZO3TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD4e7bdec2-abcc-0267-e063-6394a90ae47a2026-04-02WarningsExact identifier
unii: 15FIX9V2JP
AcetaminophenACETAMINOPHENARMY AND AIR FORCE EXCHANGE SERVICE26ae0d0a-34c0-4d16-951a-8d5a463c808b2026-04-02WarningsExact identifier
unii: 362O9ITL9D
Pain Reliever plus Sleep Aid NightTimeACETAMINOPHEN, DIPHENHYDRAMINE HCLKroger Company286ca3b3-2ecc-4f90-adb5-d7bc0ba0b4d02026-04-02WarningsExact identifier
unii: 362O9ITL9D
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc17b47994-82d6-4f9d-8249-bdb55106c9b32026-04-02WarningsExact identifier
unii: 15FIX9V2JP
Chewable Acetaminophen ChildrensACETAMINOPHENCardinal Health 110, LLC. DBA Leader8a18565c-b84e-43f8-8e96-e1dbcc39f08b2026-04-02WarningsExact identifier
unii: 362O9ITL9D
Childrens Pain RelieverACETAMINOPHENH E Bc713556c-cb9e-4ed2-bc2f-49b3d6256c0f2026-04-02WarningsExact identifier
unii: 362O9ITL9D
Nasal FourPHENYLEPHRINE HYDROCHLORIDEHyVee Inc19879fc8-4962-4c6e-87ed-b874d1d564af2026-04-01WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLLidl US LLC7227b330-590b-4731-8a58-e05a0233dd8a2026-04-01WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 362O9ITL9D
rugby cough syrupDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINPreferred Pharmaceuticals Incc0f389ec-a683-4555-8892-896b3165952a2026-04-01WarningsExact identifier
unii: 9D2RTI9KYH
SudoGestCHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCLMajor Pharmaceuticals7cd8f7f3-c262-4f7c-bcaf-068be2c952f92026-04-01WarningsExact identifier
application number: M012
unii: V1Q0O9OJ9Z
menstrual pain relief maximum strengthACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATERite Aid Corporation4a4ce4cd-1554-4772-a6f4-8f78305449492026-04-01WarningsExact identifier
unii: 362O9ITL9D
Sanatos Daytime ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLPharmadel LLC4c26be18-733a-e4a8-e063-6294a90a8b022026-04-01WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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