Preferred Plus Aller Ease

Product NDC
61715-105
11-digit product format
617150105
Labeler code
61715
Product ID
61715-105_717aede8-7b66-4848-a540-a7c2a22dd608
Type
HUMAN OTC DRUG
Nonproprietary name
fexofenadine hcl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Kinray
Application
ANDA076447
Marketing category
ANDA
Marketing start
2014-06-17
Marketing end
0000-00-00
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
180 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61715-105DDiscontinued by firm2026-08-11
excluded packagepackage61715-10561715-105-30DDiscontinued by firm2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61715-105-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61715-105-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61715-105-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61715-105-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61715-105-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61715-105-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61715-105-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61715-105-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61715-105-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61715-105-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61715-105-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61715-105-30557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076447-001FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2005-09-01
A076447-002FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2005-09-01
A076447-003FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2005-09-01
A076447-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2011-04-13
A076447-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2011-04-13
A076447-006FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2011-04-13
A076447-007FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2011-04-13
A076447-008FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2011-04-13

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 9 · 328 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076447-001FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORALAB2005-09-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076447-002FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORALAB2005-09-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076447-003FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORALAB2005-09-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076447-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-04-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076447-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-04-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076447-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-04-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076447-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-04-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076447-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-04-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076447-001FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORALAB2005-09-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076447-002FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORALAB2005-09-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076447-003FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORALAB2005-09-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076447-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-04-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076447-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-04-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076447-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-04-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076447-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-04-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076447-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-04-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A076447-001FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORALAB2005-09-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076447-002FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORALAB2005-09-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076447-003FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORALAB2005-09-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076447-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-04-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076447-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-04-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076447-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-04-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076447-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-04-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076447-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-04-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076447-001FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORALAB2005-09-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076447-002FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORALAB2005-09-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076447-003FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORALAB2005-09-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076447-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-04-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076447-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-04-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076447-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-04-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076447-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-04-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076447-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-04-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076447-001FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORALAB2005-09-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076447-002FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORALAB2005-09-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076447-003FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORALAB2005-09-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076447-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-04-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076447-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-04-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076447-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-04-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076447-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-04-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076447-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-04-13b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076447-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076447-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076447-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076447-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076447-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076447-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076447-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076447-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076447-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076447-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076447-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076447-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076447-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076447-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076447-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076447-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076447-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076447-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076447-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076447-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076447-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076447-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076447-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076447-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076447-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076447-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076447-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076447-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076447-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076447-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076447-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076447-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076447-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076447-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076447-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076447-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076447-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076447-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076447-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076447-001AB18072bd15b7f6…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZUPREFERRED PLUS ALLER EASE (FEXOFENADINE HCL) TABLET, FILM COATED [KINRAY]1
FEXOFENADINEACTIVE MOIETYE6582LOH6VPREFERRED PLUS ALLER EASE (FEXOFENADINE HCL) TABLET, FILM COATED [KINRAY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREFERRED PLUS ALLER EASE (FEXOFENADINE HCL) TABLET, FILM COATED [KINRAY]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PREFERRED PLUS ALLER EASE (FEXOFENADINE HCL) TABLET, FILM COATED [KINRAY]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675PREFERRED PLUS ALLER EASE (FEXOFENADINE HCL) TABLET, FILM COATED [KINRAY]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPREFERRED PLUS ALLER EASE (FEXOFENADINE HCL) TABLET, FILM COATED [KINRAY]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PREFERRED PLUS ALLER EASE (FEXOFENADINE HCL) TABLET, FILM COATED [KINRAY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPREFERRED PLUS ALLER EASE (FEXOFENADINE HCL) TABLET, FILM COATED [KINRAY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPREFERRED PLUS ALLER EASE (FEXOFENADINE HCL) TABLET, FILM COATED [KINRAY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREFERRED PLUS ALLER EASE (FEXOFENADINE HCL) TABLET, FILM COATED [KINRAY]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APREFERRED PLUS ALLER EASE (FEXOFENADINE HCL) TABLET, FILM COATED [KINRAY]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EPREFERRED PLUS ALLER EASE (FEXOFENADINE HCL) TABLET, FILM COATED [KINRAY]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PREFERRED PLUS ALLER EASE (FEXOFENADINE HCL) TABLET, FILM COATED [KINRAY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPREFERRED PLUS ALLER EASE (FEXOFENADINE HCL) TABLET, FILM COATED [KINRAY]1

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CareOne Allergy ReliefFEXOFENADINE HCLAmerican Sales Company65720e72-c20d-4363-92ab-76596e043bc02021-07-12WarningsExact identifier
application applno (ANDA): 076447
application number: ANDA076447