FDA.reportPublic FDA data

NDC 70677-1256-01 - Fexofenadine HCL

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
70677-1256
Requested NDC
70677-1256-01
Package NDCs from labels
70677-1256-1, 70677-1256-2, 70677-1256-01
Manufacturer
Strategic Sourcing Services | Hetero Labs Limited Unit V
Effective date
2025-03-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fexofenadine HCL - Strategic Sourcing Services | Hetero Labs Limited Unit VStrategic Sourcing Services | Hetero Labs Limited Unit V2025-03-24HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1256-1Fexofenadine HCL1 in 1 CARTONTABLET11
70677-1256-1Fexofenadine HCL30 in 1 BOTTLETABLET301
70677-1256-2Fexofenadine HCL1 in 1 CARTONTABLET11
70677-1256-2Fexofenadine HCL500 in 1 BOTTLETABLET5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1256FEXOFENADINE HCL (FEXOFENADINE HCL) TABLET [STRATEGIC SOURCING SERVICES]1Current NDC, 4 package rows20250501_722eda62-9204-400a-8db4-e4aba9cd443b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1256-1EA - Each70677-1256214cf67b-4aaa-48c1-887b-a3b50de12a8712025-05-14
70677-1256-2EA - Each70677-12568722da54-5828-48f9-bf79-d14ca66854b812025-05-14

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 4 of 146 · 2,911 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
unii: 2S068B75ZU
Continuous Correction CreamTITANIUM DIOXIDEBaxter of California, LLC1cbcc648-f2e1-af60-e063-6294a90ad4bb2026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
unii: 15FIX9V2JP
SmogstatECHINACEA (ANGUSTIFOLIA), HYPERICUM PERFORATUM, HYDRASTIS CANADENSIS, SYMPHYTUM OFFICINALE, ARSENICUM ALBUM, CARBO VEGETABILIS, CAUSTICUM, KALI CARBONICUM, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEAEnergique, Inc.59f63e2b-24fa-43a0-8334-02e6729c6ac12026-07-31WarningsExact identifier
unii: ETJ7Z6XBU4
Muscle IcePHYTOLACCA DECANDRA, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, MAGNESIA PHOSPHORICA, SILICEA, MENTHOL (CRYSTALS)Peaceful Mountain, Inc.03b6e2a9-f335-4ae2-9011-80bd019afb722026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
BioplasmaSILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDEHyland's Inc.dd0a7ed2-d112-4b96-e053-2995a90ac6b62026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
FexofenadineFEXOFENADINEYYBA Corp579c7ff9-0c44-1d46-e063-6294a90aef342026-07-27WarningsExact identifier
unii: 2S068B75ZU
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
unii: 15FIX9V2JP
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: 6OZP39ZG8H
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC57110309-9a3d-025f-e063-6394a90a015a2026-07-22WarningsExact identifier
unii: 1K09F3G675
Allergy ReliefFEXOFENADINE HCLP & L Development, LLC35b807b5-2e7a-446b-b378-eb5391ddfd142026-07-22WarningsExact identifier
rxcui: 997420
unii: 2S068B75ZU
HIVES RELIEFFEXOFENADINE HYDROCHLORIDEWalgreen Companya79edb5d-02d9-4c53-9509-c69fd61156862026-07-22WarningsExact identifier
rxcui: 997420
unii: 2S068B75ZU
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
unii: 15FIX9V2JP
Fexofenadine HCLFEXOFENADINE HCLWalmart Inc.353323b7-67ce-7ce6-e063-6394a90a77d42026-07-21WarningsExact identifier
application number: ANDA204097
rxcui: 997420
unii: 2S068B75ZU
Allergy ReliefFEXOFENADINE HYDROCHLORIDEKroger Company2718d6a2-0678-4703-9a5a-26b27d7539422026-07-20WarningsExact identifier
rxcui: 997420
unii: 2S068B75ZU
MENS SPF50 ALL IN ONE SUNSCREENMENS SPF50 ALL IN ONE SUNSCREENLance (Guangzhou) Biological Technology Co., Ltd.57074480-77fd-cc06-e063-6294a90a28d42026-07-20WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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