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 43 of 148 · 2,944 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 3.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorae7ca27f-7806-452e-9935-4a4abc37a5eb2025-12-19WarningsExact identifier
unii: 15FIX9V2JP
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2WPOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior9bbacc16-8d60-4170-a3cb-0bfb748177a22025-12-19WarningsExact identifier
unii: 15FIX9V2JP
YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 FAIRTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC4327c775-e179-47d8-9b4b-945fc1b0b2342025-12-19WarningsExact identifier
unii: 15FIX9V2JP
YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 LIGHTTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC0f3a9b6a-b1b2-4d69-88de-6f22c17a48442025-12-19WarningsExact identifier
unii: 15FIX9V2JP
YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 TANTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC5cce7646-d9f5-454b-b7a8-a5a6b62a19162025-12-19WarningsExact identifier
unii: 15FIX9V2JP
YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 RICHTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC7da16dd7-c26c-4c4e-905f-3bbb878022cc2025-12-19WarningsExact identifier
unii: 15FIX9V2JP
YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 MEDIUM-TANTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC85f3dd47-4f1f-4fa3-a171-4f4b7707191c2025-12-19WarningsExact identifier
unii: 15FIX9V2JP
YOUR SKIN BUT BETTER CC ILLUMINATION FAIRTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC4e5764f3-9d9e-460b-ab1e-36f280281dec2025-12-19WarningsExact identifier
unii: 15FIX9V2JP
YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 MEDIUMTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCe700dc6e-e7ae-47ee-9974-430bfd045b4f2025-12-19WarningsExact identifier
unii: 15FIX9V2JP
YOUR SKIN BUT BETTER CC ILLUMINATION MEDIUM-TANTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCc7924d60-03fb-4a4d-b718-e324f6f1f65f2025-12-19WarningsExact identifier
unii: 15FIX9V2JP
Fexofenadine HCLFEXOFENADINE HCLSafeway, Incf32e9cb6-af93-e60a-e053-2995a90a42f52025-12-19WarningsExact identifier
rxcui: 997420
unii: 2S068B75ZU
Fexofenadine HCLFEXOFENADINE HCLMeijer, Inc.16de2c5d-b27b-9fb4-e063-6394a90a83902025-12-19WarningsExact identifier
rxcui: 997420
unii: 2S068B75ZU
Fexofenadine HCLFEXOFENADINE HCLMeijer181c7faf-b27d-0a2d-e063-6294a90ad1f42025-12-19WarningsExact identifier
rxcui: 997420
unii: 2S068B75ZU
Fexofenadine HCLFEXOFENADINE HCLTARGET CORPORATIONfdb8451b-fba3-c7ca-e053-6294a90a05d72025-12-19WarningsExact identifier
rxcui: 997420
unii: 2S068B75ZU
Fexofenadine HCLFEXOFENADINE HCLWalgreensfd775af1-782e-bb4f-e053-6294a90aaa5d2025-12-19WarningsExact identifier
rxcui: 997420
unii: 2S068B75ZU
Fexofenadine HCLFEXOFENADINE HCLCVS00ef8467-30a0-7579-e063-6294a90a75af2025-12-19WarningsExact identifier
rxcui: 997420
unii: 2S068B75ZU
Fexofenadine HCLFEXOFENADINE HCLCVS013ef192-5184-b720-e063-6394a90a98c42025-12-19WarningsExact identifier
rxcui: 997420
unii: 2S068B75ZU
Fexofenadine HCLFEXOFENADINE HCLWalgreens0eaf28a5-f8dd-3888-e063-6394a90a8cc62025-12-19WarningsExact identifier
rxcui: 997420
unii: 2S068B75ZU
Fexofenadine HClFEXOFENADINE HCLRite Aid1dd9affe-b55d-e1fb-e063-6394a90a77942025-12-19WarningsExact identifier
rxcui: 997420
unii: 2S068B75ZU
Fexofenadine HClFEXOFENADINE HCLRite Aid1dda06c9-8e0f-38d7-e063-6394a90aba3e2025-12-19WarningsExact identifier
rxcui: 997420
unii: 2S068B75ZU

Reported adverse events (FAERS/openFDA)#

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