NDC 62756-545-31 - 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
62756-545
Requested NDC
62756-545-31
Package NDCs from labels
62756-545-31, 62756-545-27, 62756-545-94, 62756-545-25, 62756-545-15, 62756-545-17, 62756-545-18, 62756-545-19, 62756-545-20, 62756-545-21, 62756-545-22, 62756-545-83, 62756-545-88, 62756-545-74, 62756-545-66, 62756-545-77, 62756-545-64, 62756-545-76, 62756-545-78
Manufacturer
Sun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Industries Limited
Effective date
2022-06-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fexofenadine Hydrochloride Tablets, USPSun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Industries Limited2022-06-27Human OTC Drug Label
Fexofenadine Hydrochloride Tablets, USPSun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Industries Limited2018-10-26Human OTC Drug Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDCEffectiveIndexing SPLRelated label
62756-545-152024-01-301030e365-141b-111a-e063-dadaa90a10e2Fexofenadine Hydrochloride Tablets, USP
62756-545-172024-01-301030e365-141b-111a-e063-dadaa90a10e2Fexofenadine Hydrochloride Tablets, USP
62756-545-182024-01-301030e365-141b-111a-e063-dadaa90a10e2Fexofenadine Hydrochloride Tablets, USP
62756-545-192024-01-301030e365-141b-111a-e063-dadaa90a10e2Fexofenadine Hydrochloride Tablets, USP
62756-545-202024-01-301030e365-141b-111a-e063-dadaa90a10e2Fexofenadine Hydrochloride Tablets, USP
62756-545-212024-01-301030e365-141b-111a-e063-dadaa90a10e2Fexofenadine Hydrochloride Tablets, USP
62756-545-222024-01-301030e365-141b-111a-e063-dadaa90a10e2Fexofenadine Hydrochloride Tablets, USP
62756-545-252024-01-301030e365-141b-111a-e063-dadaa90a10e2Fexofenadine Hydrochloride Tablets, USP
62756-545-272024-01-301030e365-141b-111a-e063-dadaa90a10e2Fexofenadine Hydrochloride Tablets, USP
62756-545-942024-01-301030e365-141b-111a-e063-dadaa90a10e2Fexofenadine Hydrochloride Tablets, USP
62756-545-642023-01-30f386c64a-0d6d-0266-e053-dadaa90a7c1aFexofenadine Hydrochloride Tablets, USP
62756-545-662023-01-30f386c64a-0d6d-0266-e053-dadaa90a7c1aFexofenadine Hydrochloride Tablets, USP
62756-545-742023-01-30f386c64a-0d6d-0266-e053-dadaa90a7c1aFexofenadine Hydrochloride Tablets, USP
62756-545-762023-01-30f386c64a-0d6d-0266-e053-dadaa90a7c1aFexofenadine Hydrochloride Tablets, USP
62756-545-772023-01-30f386c64a-0d6d-0266-e053-dadaa90a7c1aFexofenadine Hydrochloride Tablets, USP
62756-545-782023-01-30f386c64a-0d6d-0266-e053-dadaa90a7c1aFexofenadine Hydrochloride Tablets, USP
62756-545-832023-01-30f386c64a-0d6d-0266-e053-dadaa90a7c1aFexofenadine Hydrochloride Tablets, USP
62756-545-882023-01-30f386c64a-0d6d-0266-e053-dadaa90a7c1aFexofenadine Hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62756-545-15FEXOFENADINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED3010
62756-545-17FEXOFENADINE HYDROCHLORIDE45 in 1 BOTTLETABLET, FILM COATED4510
62756-545-18FEXOFENADINE HYDROCHLORIDE70 in 1 BOTTLETABLET, FILM COATED7010
62756-545-19FEXOFENADINE HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED9010
62756-545-20FEXOFENADINE HYDROCHLORIDE150 in 1 BOTTLETABLET, FILM COATED15010
62756-545-21FEXOFENADINE HYDROCHLORIDE180 in 1 BOTTLETABLET, FILM COATED18010
62756-545-22FEXOFENADINE HYDROCHLORIDE300 in 1 BOTTLETABLET, FILM COATED30010
62756-545-25FEXOFENADINE HYDROCHLORIDE3 in 1 CARTONTABLET, FILM COATED310
62756-545-27FEXOFENADINE HYDROCHLORIDE1 in 1 CARTONTABLET, FILM COATED110
62756-545-31FEXOFENADINE HYDROCHLORIDE5 in 1 BLISTER PACKTABLET, FILM COATED510
62756-545-94FEXOFENADINE HYDROCHLORIDE2 in 1 CARTONTABLET, FILM COATED210
62756-545-64FEXOFENADINE HYDROCHLORIDE5 in 1 CARTONTABLET, FILM COATED56
62756-545-64FEXOFENADINE HYDROCHLORIDE6 in 1 BLISTER PACKTABLET, FILM COATED66
62756-545-66FEXOFENADINE HYDROCHLORIDE5 in 1 BLISTER PACKTABLET, FILM COATED56
62756-545-66FEXOFENADINE HYDROCHLORIDE2 in 1 CARTONTABLET, FILM COATED26
62756-545-74FEXOFENADINE HYDROCHLORIDE1 in 1 CARTONTABLET, FILM COATED16
62756-545-74FEXOFENADINE HYDROCHLORIDE5 in 1 BLISTER PACKTABLET, FILM COATED56
62756-545-76FEXOFENADINE HYDROCHLORIDE6 in 1 BLISTER PACKTABLET, FILM COATED66
62756-545-76FEXOFENADINE HYDROCHLORIDE10 in 1 CARTONTABLET, FILM COATED106
62756-545-77FEXOFENADINE HYDROCHLORIDE5 in 1 BLISTER PACKTABLET, FILM COATED56
62756-545-77FEXOFENADINE HYDROCHLORIDE9 in 1 CARTONTABLET, FILM COATED96
62756-545-78FEXOFENADINE HYDROCHLORIDE6 in 1 BLISTER PACKTABLET, FILM COATED66
62756-545-78FEXOFENADINE HYDROCHLORIDE15 in 1 CARTONTABLET, FILM COATED156
62756-545-83FEXOFENADINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED306
62756-545-88FEXOFENADINE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-545FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]10Legacy NDC, 11 package rows20220701_47826458-4f7f-486b-aec4-ae48c3f94f5e.zip
62756-545FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]6Legacy NDC, 14 package rows20181026_04923af6-97fc-4e32-834d-1df643832d7f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZUFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
FEXOFENADINEACTIVE MOIETYE6582LOH6VFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZUFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]2
FEXOFENADINEACTIVE MOIETYE6582LOH6VFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]2

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 2 of 121 · 2,416 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: B697894SGQ
Childrens AllergyFEXOFENADINE HCLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)667c87c2-c594-49e5-92a7-f8aa140642d62026-08-12WarningsExact identifier
unii: 2S068B75ZU
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DR. SAMRAO'S OFFICE58b2ca35-11ed-d848-e063-6294a90a5b372026-08-11WarningsExact identifier
unii: 15FIX9V2JP
Childrens Fexofenadine Hydrochloride AllergyFEXOFENADINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.b21bb11d-bf74-4ee7-9cfe-5b599a3c47752026-08-11WarningsExact identifier
unii: 2S068B75ZU
SYSTANE HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.8936f66f-10fe-44ab-a26e-dd8b05dfa9972026-08-10WarningsExact identifier
unii: B697894SGQ
Journee Firm Riche Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE AND ZINC OXIDEMerz North America, Inc.d4d4bfcf-3674-4847-8ad8-1716a8e821ae2026-08-10WarningsExact identifier
unii: 15FIX9V2JP
VEIRFOO Brightening Hydrating Antiwrinkle SunscreenTITANIUM DIOXIDE, OCTINOXATELCM TECHNOLOGY Co., Ltd4cbbf8aa-8910-b7e7-e063-6294a90a4f072026-08-07WarningsExact identifier
unii: 15FIX9V2JP
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDEAurohealth LLC5413d84e-f945-4920-8981-f62978f21d672026-08-06WarningsExact identifier
rxcui: 997501
unii: 2S068B75ZU
CalamineFERRIC OXIDE REDThe Kroger Co.9ddcd6ba-1aed-48f8-a91a-54bd6f0d93082026-08-06Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDEAurohealth LLC683cb2ea-c913-48f4-8adc-2888da3b655e2026-08-06WarningsExact identifier
rxcui: 997420
unii: 2S068B75ZU
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDEAurohealth LLCeb8e67dc-e2df-4c35-bfd7-12af67e1354a2026-08-06WarningsExact identifier
rxcui: 997488
unii: 2S068B75ZU
Leader Lubricant Eye Drops 30ctPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADER8df69f2c-40c4-245c-e053-2a95a90a54062026-08-05WarningsExact identifier
unii: B697894SGQ
dg health aller easeFEXOFENADINE HYDROCHLORIDEDolgencorp Incf9239aa4-b3d0-4817-b639-61ad1383f7072026-08-05WarningsExact identifier
rxcui: 997420
unii: 2S068B75ZU
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
unii: 15FIX9V2JP
LEADER 12HR ALLERGY AND CONGESTION RELIEFFEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDECardinal Health 110, LLC. dba Leader1400014a-2fa6-4a4f-8eb9-85ac049b4b702026-08-03WarningsExact identifier
unii: 2S068B75ZU
EQUATE ALLERGY RELIEF DFEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEWALMART INC.6daeb739-a112-4a37-abbb-0bbc41b42df32026-08-03WarningsExact identifier
unii: 2S068B75ZU
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
unii: 15FIX9V2JP
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDENUVICARE LLCdd0da52b-fc82-4ec9-854c-0d7c52e926fb2026-08-03WarningsExact identifier
rxcui: 997501
unii: 2S068B75ZU
Continuous Correction CreamTITANIUM DIOXIDEBaxter of California, LLC1cbcc648-f2e1-af60-e063-6294a90ad4bb2026-07-31WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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