allergy relief

Product NDC
11822-0571
Requested package NDC
11822-0571-1
11-digit product format
118220571
Labeler code
11822
Product ID
11822-0571_69338bed-2052-4a94-bc8d-1f3bd4af725b
Type
HUMAN OTC DRUG
Nonproprietary name
fexofenadine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rite Aid Corporation
Application
ANDA076447
Marketing category
ANDA
Marketing start
2011-04-15
Marketing end
0000-00-00
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
180 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage11822-057111822-0571-1DDiscontinued 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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage11822-057111822-0571-1DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZUALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [RITE AID CORPORATION]3
FEXOFENADINEACTIVE MOIETYE6582LOH6VALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [RITE AID CORPORATION]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [RITE AID CORPORATION]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [RITE AID CORPORATION]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [RITE AID CORPORATION]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [RITE AID CORPORATION]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [RITE AID CORPORATION]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [RITE AID CORPORATION]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [RITE AID CORPORATION]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [RITE AID CORPORATION]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [RITE AID CORPORATION]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [RITE AID CORPORATION]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [RITE AID CORPORATION]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [RITE AID CORPORATION]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0571ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [RITE AID CORPORATION]6Legacy NDC20210507_b1e9235d-8966-418c-a47a-7499399675b8.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 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0571-1118220571013 BLISTER PACK in 1 CARTON (11822-0571-1) > 5 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2011-04-150000-00-00NoNoCurrent