FDA.reportPublic FDA data

NDC 68554-5063-3 - 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
68554-5063-3
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 14 of 148 · 2,944 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrate ICOFFEA TOSTA, GINKGO BILOBA, GERMANIUM SESQUIOXIDE, SILICEABioActive Nutritional, Inc.c0c8d350-0257-4484-acd8-f852350173db2026-04-30WarningsExact identifier
unii: ETJ7Z6XBU4
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.509cad98-0321-2a0a-e063-6294a90a6ea92026-04-29WarningsExact identifier
unii: 15FIX9V2JP
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.509d7206-0cc1-c997-e063-6294a90a89e02026-04-29WarningsExact identifier
unii: 15FIX9V2JP
JMSOLUTION SKIN BOOST NIACINAMIDE SUNSCREENHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEGPNY CORP211dea04-faad-8ffc-e063-6294a90a8d682026-04-29WarningsExact identifier
unii: 15FIX9V2JP
Anything SPFOCTINOXATE, OCTISALATE, ZINC OXIDE, AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDEAnything SPF LLC508b8dcb-6600-6dad-e063-6294a90a565a2026-04-28WarningsExact identifier
unii: 15FIX9V2JP
Allegra Allergy, Travel BASIXFEXOFENADINE HYDROCHLORIDELil' Drug Store Products, Incb82d993a-16ff-4037-a182-7010de8e1cdd2026-04-27WarningsExact identifier
rxcui: 997420
unii: 2S068B75ZU
Johnsons Baby Mineral Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC4fe04c4b-2751-0561-e063-6394a90af7682026-04-22WarningsExact identifier
unii: 15FIX9V2JP
Lazy Face SPF 30 FacescreenTITANIUM DIOXIDE, ZINC OXIDESunny Day Creations500ee303-7302-68d5-e063-6394a90ac6d42026-04-22WarningsExact identifier
unii: 15FIX9V2JP
Allegra AllergyFEXOFENADINE HYDROCHLORIDENavajo Manufacturing Company Inc.e8a00fa1-79af-4ce6-885f-0ce12c5da8362026-04-22WarningsExact identifier
rxcui: 997420
unii: 2S068B75ZU
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
Goodmeds Non Drowsy Allergy ReliefFEXOFENADINE HYDROCHLORIDECabinet Health P.B.C.ae1322f5-85d6-4243-b384-2ce7f8c8d6922026-04-20WarningsExact identifier
application number: ANDA204097
rxcui: 997420
unii: 2S068B75ZU
ELROEL Pang Pang Sun Cushion S7ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEMONOGLOT HOLDINGS Inc.256bf56f-aefa-47ce-890c-5a3896c11b922026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion FairTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.3a43c7c0-7468-4b7a-95b9-f03e37f1b49b2026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion Fair LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.a251eb20-02e6-4b55-b969-c1bef2f9d7322026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion Fair PinkTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.6684d69a-89ff-41e8-81f0-3e2367811a182026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.bf24d081-85f7-4a26-9416-ecff1fe59dec2026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion Pink LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.4a09a01a-404f-4b67-91e0-666153f550e82026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion N-LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.cf7c4445-0382-47ab-aba9-b40d63e4f1cc2026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion MediumTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.80c60ffa-69e0-4b31-bd0d-fc8ff9936ba02026-04-17WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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