FDA.reportPublic FDA data

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#

NDC, Related label table
NDCRelated label
68554-5063-0Fexofenadine Hydrochloride Tablets USP, 30 mg, 60 mg and 180 mg
68554-5063-1Fexofenadine Hydrochloride Tablets USP, 30 mg, 60 mg and 180 mg
68554-5063-2Fexofenadine Hydrochloride Tablets USP, 30 mg, 60 mg and 180 mg
68554-5063-5Fexofenadine Hydrochloride Tablets USP, 30 mg, 60 mg and 180 mg
68554-5063-6Fexofenadine Hydrochloride Tablets USP, 30 mg, 60 mg and 180 mg

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 58 of 145 · 2,894 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESaving Face Skinspa Inc.351db99e-262f-b67e-e063-6394a90a34182025-12-11Exact identifier
unii: 15FIX9V2JP
Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEDAISY'S SKIN TRANSFORMATION LLC37d9fbf5-d602-d3dc-e063-6394a90abe532025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted Mineral 40TITANIUM DIOXIDE, ZINC OXIDE2301 PLASTIC SURGERY, PLLC374d53a7-be0b-4d7a-e063-6394a90a37c42025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted Mineral 40TITANIUM DIOXIDE, ZINC OXIDE2301 PLASTIC SURGERY, PLLC374df66d-eb9b-c4a7-e063-6394a90a3cc62025-12-11Exact identifier
unii: 15FIX9V2JP
Facial Mineral Sunscreen Mineral ProtectionTITANIUM DIOXIDE, ZINC OXIDECAPE COD SKIN CARE CO. INC.387f6dd5-3901-0849-e063-6294a90af8bc2025-12-11Exact identifier
unii: 15FIX9V2JP
Facial Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELEDUC, XUANTO MD387e2e59-c5db-c70e-e063-6394a90a2d262025-12-11Exact identifier
unii: 15FIX9V2JP
Facial Mineral Sunscreen Mineral ProtectionTITANIUM DIOXIDE, ZINC OXIDECAPE COD SKIN CARE CO. INC.390779a8-4556-27a5-e063-6294a90a12002025-12-11Exact identifier
unii: 15FIX9V2JP
non-tinted sheer matte mineralTITANIUM DIOXIDE, ZINC OXIDENEXTEX CORPORATION35ba6cc9-0d49-6d0c-e063-6394a90ac7c32025-12-11Exact identifier
unii: 15FIX9V2JP
sheer tinted matte mineralTITANIUM DIOXIDE, ZINC OXIDENEXTEX CORPORATION35ba9ca7-fe5c-9824-e063-6394a90a5c462025-12-11Exact identifier
unii: 15FIX9V2JP
illuminating mineral mousseTITANIUM DIOXIDE, ZINC OXIDENEXTEX CORPORATION35bb4d67-373f-f60c-e063-6394a90a974d2025-12-11Exact identifier
unii: 15FIX9V2JP
Soft Focus Mineral Defense TintedTITANIUM DIOXIDE, ZINC OXIDESPOTLESS SKIN STUDIO387f1ea9-4764-3abe-e063-6394a90adde02025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted Matte Defense Sunscreen PrimerTITANIUM DIOXIDE, ZINC OXIDEMint Skin Incorporated352efbee-cab4-c515-e063-6294a90a46f22025-12-11Exact identifier
unii: 15FIX9V2JP
Daily Defense Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELEDUC, XUANTO MD387e6e79-94db-dbb1-e063-6394a90aefd62025-12-11Exact identifier
unii: 15FIX9V2JP
Matte Defense Sunscreen PrimerTITANIUM DIOXIDE, ZINC OXIDEMint Skin Incorporated352f5c53-3075-f437-e063-6394a90a4c4e2025-12-11Exact identifier
unii: 15FIX9V2JP
PreventionTITANIUM DIOXIDE, ZINC OXIDENoble Center for Healthy Aging LLC387dbf46-4316-a15d-e063-6394a90adeb12025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted Matte Defense Sunscreen PrimerTITANIUM DIOXIDE, ZINC OXIDEMint Skin Incorporated352f8de3-8ff0-4098-e063-6294a90ace4d2025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted Matte Defense Sunscreen PrimerTITANIUM DIOXIDE, ZINC OXIDEMint Skin Incroporated35305bf1-8947-f275-e063-6294a90a30242025-12-11Exact identifier
unii: 15FIX9V2JP
DIZZINESS HPOYSTER SHELL CALCIUM CARBONATE CRUDE, CHENOPODIUM AMBROSIOIDES, ANAMIRTA COCCULUS SEED, CONIUM MACULATUM FLOWERING TOP, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, PULSATILLA VULGARIS, SILICON DIOXIDENatural Creations, Inc.9701096b-5efa-4acd-9227-339ecedfd6722025-12-10WarningsExact identifier
unii: ETJ7Z6XBU4
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEKroger Companyac67476a-2888-53c4-0a10-7f73ac2580c52025-12-10WarningsExact identifier
unii: 2S068B75ZU
ProtectME Tinted Mineral SPF 40TITANIUM DIOXIDE, ZINC OXIDEPUREFECTION LA, INC.33dccd5d-8db1-f699-e063-6394a90a59a22025-12-10Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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