NDC 68554-5063-4 - Fexofenadine Hydrochloride

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
68554-5063
Requested NDC
68554-5063-4
Package NDCs from labels
68554-5063-0, 68554-5063-1, 68554-5063-2, 68554-5063-4, 68554-5063-5, 68554-5063-3, 68554-5063-6
Manufacturer
Hetero Labs Limited
Effective date
2016-09-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fexofenadine Hydrochloride - Hetero Labs LimitedHetero Labs Limited2016-09-08Human OTC Drug Label

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68554-5063-0Fexofenadine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
68554-5063-0Fexofenadine Hydrochloride1 in 1 CARTONTABLET, FILM COATED12
68554-5063-1Fexofenadine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1002
68554-5063-1Fexofenadine Hydrochloride1 in 1 CARTONTABLET, FILM COATED12
68554-5063-2Fexofenadine Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5002
68554-5063-2Fexofenadine Hydrochloride1 in 1 CARTONTABLET, FILM COATED12
68554-5063-3Fexofenadine Hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED102
68554-5063-4Fexofenadine Hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED102
68554-5063-5Fexofenadine Hydrochloride7 in 1 CARTONTABLET, FILM COATED72
68554-5063-6Fexofenadine Hydrochloride15 in 1 CARTONTABLET, FILM COATED152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68554-5063FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [HETERO LABS LIMITED]2Legacy NDC, 10 package rows20160909_412af925-12e9-405f-b3c3-d5c3d0b5d5c2.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 85 of 144 · 2,880 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sulwhasoo Perfecting Cushion NO.17N1 VanillaOCTINOXATE, TITANIUM DIOXIDE, AND HOMOSALATEAmorepacific Corporation3350f28e-22b4-904c-e063-6394a90a1c812025-04-21WarningsExact identifier
unii: 15FIX9V2JP
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEAurohealth LLCbced0a2e-047e-456e-bbd2-495e83bf07ee2025-04-18WarningsExact identifier
unii: 2S068B75ZU
Cicapair Soothing Color Correcting Treatment Cica Complex Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEHave & Be Co., Ltd.32c1aba6-5e29-aba9-e063-6394a90a8e562025-04-14WarningsExact identifier
unii: 15FIX9V2JP
REPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRYOCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDECLINIQUE LABORATORIES LLC07701e11-8a7e-44c5-b46e-5b48264eacad2025-04-14WarningsExact identifier
unii: 15FIX9V2JP
Smoothing Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEDANIEL BEHROOZAN MD A MEDICAL CORPORATION327246c2-9d7a-2d34-e063-6294a90a5fb72025-04-10Exact identifier
unii: 15FIX9V2JP
Clarity Rx Physical Skin Defense SPF 50ZINC OXIDE AND TITANIUM DIOXIDETopiderm, Inc.b5111012-97b9-4908-95a0-d09595f9c4d92025-04-10WarningsExact identifier
unii: 15FIX9V2JP
Tinted Mineral Sunscreen SPF 50ZINC OXIDE AND TITANIUM DIOXIDETopiderm, Inc.13e5085f-df2b-46b2-b063-e58ce43799052025-04-09WarningsExact identifier
unii: 15FIX9V2JP
fexofenadine hclFEXOFENADINE HCLAphena Pharma Solutions - Tennessee, LLC31e71ee7-c4b5-6c1c-e063-6294a90a15132025-04-03WarningsExact identifier
rxcui: 997420
unii: 2S068B75ZU
exchange select aller easeFEXOFENADINE HYDROCHLORIDEArmy & Air Force Exchange Service6a9597a1-f024-4497-bc52-3d54827588222025-04-03WarningsExact identifier
rxcui: 997420
unii: 2S068B75ZU
Leader 24HR Allergy ReliefFEXOFENADINE HYDROCHLORIDECardinal Health 110, LLC. dba Leadere509800a-e33d-4d22-a6b4-97b7c73b14862025-04-01WarningsExact identifier
rxcui: 997420
unii: 2S068B75ZU
ALEX MD PHD Sheer Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDEPHYSICIAN LABORATORIES INC8f64c4fa-92ee-4af0-ab1b-6c3673f9a6222025-03-28WarningsExact identifier
unii: 15FIX9V2JP
ALEX MD PHD Tinted Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDEPHYSICIAN LABORATORIES INC93873c34-5c72-43c8-b6c2-c65b596191d72025-03-28WarningsExact identifier
unii: 15FIX9V2JP
City Skin Age Defense Broad Spectrum SPF 50TITANIUM DIOXIDE AND ZINC OXIDEMurad, LLCf8c572a2-b4bc-49e9-95df-359f05bd69b72025-03-28WarningsExact identifier
unii: 15FIX9V2JP
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Deep FairLight Neutral Tan Rich Honey LightMedium and Neutral MediumTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCe17dc640-30e9-441b-a212-ef1508af79442025-03-25WarningsExact identifier
unii: 15FIX9V2JP
it cosmetics Your Skin But Better CC Plus Oil Free Matte Poreless Finish Full Coverage Broad Spectrum SPF 40 Sunscreen All ShadesTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCb7d184fb-4a9a-4720-9b00-bf0caa257a8c2025-03-25WarningsExact identifier
unii: 15FIX9V2JP
Fexofenadine HCLFEXOFENADINE HCLStrategic Sourcing Services722eda62-9204-400a-8db4-e4aba9cd443b2025-03-24WarningsExact identifier
application number: ANDA204097
rxcui: 997420
unii: 2S068B75ZU
DOMINAS DARK SPOT TINTED SUNSCREENOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDELG H&H CO., LTD.2b6140cf-7e34-1658-e063-6394a90a32712025-03-24WarningsExact identifier
unii: 15FIX9V2JP
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Illuminating 40mL with Pink Algae SPF 50TITANIUM OXIDE, ZINC OXIDENAKED SUNDAYS PTY LTD01273e8c-aef0-d800-e063-6294a90abd492025-03-23WarningsExact identifier
unii: 15FIX9V2JP
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS BRONZE 40mL with wild Rosella SPF 50TITANIUM OXIDE, ZINC OXIDENAKED SUNDAYS PTY LTD01221d57-9eec-7e77-e063-6394a90a60422025-03-23WarningsExact identifier
unii: 15FIX9V2JP
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Blush 40mL SPF 50TITANIUM OXIDE, ZINC OXIDENAKED SUNDAYS PTY LTD0ce809a1-45fb-9d4d-e063-6294a90a26a22025-03-23WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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