Allegra Allergy

Product NDC
41167-4124
11-digit product format
411674124
Labeler code
41167
Product ID
41167-4124_fb8ea8ca-b8a9-46af-9c21-d2df1100e9ff
Type
HUMAN OTC DRUG
Nonproprietary name
fexofenadine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Chattem, Inc.
Application
NDA020872
Marketing category
NDA
Marketing start
2020-10-01
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
180 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 packagepackage41167-412441167-4124-7DDiscontinued 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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020872-005CHILDREN'S ALLEGRA ALLERGYFEXOFENADINE HYDROCHLORIDE30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2011-01-24
N020872-006CHILDREN'S ALLEGRA HIVESFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORALRLD2011-01-24
N020872-007ALLEGRA ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORALRLD2011-01-24
N020872-008ALLEGRA HIVESFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORALRLD2011-01-24
N020872-009ALLEGRA HIVESFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORALRLD, RS2011-01-24
N020872-010ALLEGRA ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORALRLD, RS2011-01-24

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 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020872-005CHILDREN'S ALLEGRA ALLERGY30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2011-01-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020872-006CHILDREN'S ALLEGRA HIVES30MGTABLET / ORALRLD2011-01-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020872-007ALLEGRA ALLERGY60MGTABLET / ORALRLD2011-01-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020872-008ALLEGRA HIVES60MGTABLET / ORALRLD2011-01-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020872-009ALLEGRA HIVES180MGTABLET / ORALRLD, RS2011-01-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020872-010ALLEGRA ALLERGY180MGTABLET / ORALRLD, RS2011-01-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020872-005CHILDREN'S ALLEGRA ALLERGY30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2011-01-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020872-006CHILDREN'S ALLEGRA HIVES30MGTABLET / ORALRLD2011-01-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020872-007ALLEGRA ALLERGY60MGTABLET / ORALRLD2011-01-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020872-008ALLEGRA HIVES60MGTABLET / ORALRLD2011-01-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020872-009ALLEGRA HIVES180MGTABLET / ORALRLD, RS2011-01-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020872-010ALLEGRA ALLERGY180MGTABLET / ORALRLD, RS2011-01-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N020872-005CHILDREN'S ALLEGRA ALLERGY30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2011-01-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020872-006CHILDREN'S ALLEGRA HIVES30MGTABLET / ORALRLD2011-01-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020872-007ALLEGRA ALLERGY60MGTABLET / ORALRLD2011-01-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020872-008ALLEGRA HIVES60MGTABLET / ORALRLD2011-01-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020872-009ALLEGRA HIVES180MGTABLET / ORALRLD, RS2011-01-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020872-010ALLEGRA ALLERGY180MGTABLET / ORALRLD, RS2011-01-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020872-005CHILDREN'S ALLEGRA ALLERGY30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2011-01-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020872-006CHILDREN'S ALLEGRA HIVES30MGTABLET / ORALRLD2011-01-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020872-007ALLEGRA ALLERGY60MGTABLET / ORALRLD2011-01-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020872-008ALLEGRA HIVES60MGTABLET / ORALRLD2011-01-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020872-009ALLEGRA HIVES180MGTABLET / ORALRLD, RS2011-01-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020872-010ALLEGRA ALLERGY180MGTABLET / ORALRLD, RS2011-01-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020872-005CHILDREN'S ALLEGRA ALLERGY30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2011-01-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020872-006CHILDREN'S ALLEGRA HIVES30MGTABLET / ORALRLD2011-01-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020872-007ALLEGRA ALLERGY60MGTABLET / ORALRLD2011-01-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020872-008ALLEGRA HIVES60MGTABLET / ORALRLD2011-01-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020872-009ALLEGRA HIVES180MGTABLET / ORALRLD, RS2011-01-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020872-010ALLEGRA ALLERGY180MGTABLET / ORALRLD, RS2011-01-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020872-005CHILDREN'S ALLEGRA ALLERGY30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2011-01-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020872-006CHILDREN'S ALLEGRA HIVES30MGTABLET / ORALRLD2011-01-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020872-007ALLEGRA ALLERGY60MGTABLET / ORALRLD2011-01-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020872-008ALLEGRA HIVES60MGTABLET / ORALRLD2011-01-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020872-009ALLEGRA HIVES180MGTABLET / ORALRLD, RS2011-01-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020872-010ALLEGRA ALLERGY180MGTABLET / ORALRLD, RS2011-01-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020872-005CHILDREN'S ALLEGRA ALLERGY30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2011-01-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020872-006CHILDREN'S ALLEGRA HIVES30MGTABLET / ORALRLD2011-01-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020872-007ALLEGRA ALLERGY60MGTABLET / ORALRLD2011-01-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020872-008ALLEGRA HIVES60MGTABLET / ORALRLD2011-01-242680178bc6a6…

Additional Listing Data#

Finished product
Yes
Brand name base
Allegra Allergy
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FEXOFENADINE HYDROCHLORIDE180 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2S068B75ZUInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
997420Internal RxNorm lookup
997422Internal RxNorm lookup
997501Internal RxNorm lookup
997502Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd173Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41167-4124-0Allegra Allergy90 in 1 BOTTLETABLET, FILM COATED9064
41167-4124-0Allegra Allergy1 in 1 CARTONTABLET, FILM COATED164
41167-4124-3Allegra Allergy2 in 1 PACKAGETABLET, FILM COATED264
41167-4124-5Allegra Allergy55 in 1 BOTTLETABLET, FILM COATED5564
41167-4124-7Allegra Allergy84 in 1 BOTTLETABLET, FILM COATED8464
41167-4124-7Allegra Allergy1 in 1 CARTONTABLET, FILM COATED164
41167-4124-8Allegra Allergy1 in 1 CARTONTABLET, FILM COATED164
41167-4124-8Allegra Allergy100 in 1 BOTTLETABLET, FILM COATED10064

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41167-4124-0EA - Each41167-4124d0d30baa-eca0-4e55-860a-4f0cc7069c9a12022-09-12
41167-4124-3EA - Each41167-41248cb7279c-fe40-4a52-85a4-50def71f52ce12023-03-13
41167-4124-7EA - Each41167-41245cd50192-8f0e-404f-99cd-bd64b88033a212022-09-12

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-4124ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [CHATTEM, INC.]62Current NDC, Legacy NDC, 8 package rows20241116_81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd173.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allegra Allergy, Travel BASIXFEXOFENADINE HYDROCHLORIDELil' Drug Store Products, Incb82d993a-16ff-4037-a182-7010de8e1cdd2026-04-27WarningsExact identifier
application applno (NDA): 020872
application number: NDA020872
Allegra AllergyFEXOFENADINE HYDROCHLORIDENavajo Manufacturing Company Inc.e8a00fa1-79af-4ce6-885f-0ce12c5da8362026-04-22WarningsExact identifier
application applno (NDA): 020872
application number: NDA020872
Allegra AllergyFEXOFENADINE HYDROCHLORIDEChattem, Inc.81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd1732026-04-14WarningsExact identifier
application applno (NDA): 020872
application number: NDA020872
ndc (product): 41167-4124
Allegra Hives 24hrFEXOFENADINE HYDROCHLORIDEChattem, Inc.490b4c5f-448b-4563-928b-837117b59b9f2026-01-12WarningsExact identifier
application applno (NDA): 020872
application number: NDA020872
Allegra AllergyFEXOFENADINE HYDROCHLORIDEChattem, Inc.f061d6b1-89f7-4d5f-ac59-9c73408517c12025-02-19WarningsExact identifier
application applno (NDA): 020872
application number: NDA020872
ALLEGRA ALLERGYFEXOFENADINE HYDROCHLORIDEA-S Medication Solutionsb5ce28f8-f6c3-4113-9317-e1c98e5030ef2024-07-30WarningsExact identifier
application applno (NDA): 020872
application number: NDA020872

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997422Allegra 180 MG Oral TabletPSN81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd17364
997502Allegra Allergy 60 MG Oral TabletPSN81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd17364
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd17364
997501fexofenadine HCl 60 MG Oral TabletPSN81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd17364
997422fexofenadine hydrochloride 180 MG Oral Tablet [Allegra]SBD81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd17364
997502fexofenadine hydrochloride 60 MG Oral Tablet [Allegra]SBD81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd17364
997420fexofenadine hydrochloride 180 MG Oral TabletSCD81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd17364
997501fexofenadine hydrochloride 60 MG Oral TabletSCD81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd17364
997422Allegra 180 MG Oral TabletSY81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd17364
997502Allegra 60 MG Oral TabletSY81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd17364
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd17364

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41167-4124-0411674124001 BOTTLE in 1 CARTON (41167-4124-0) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-12-010000-00-00NoNoCurrent
41167-4124-3411674124032 BOTTLE in 1 PACKAGE (41167-4124-3) / 55 TABLET, FILM COATED in 1 BOTTLE (41167-4124-5) 2 bottle2020-10-010000-00-00NoNoCurrent
41167-4124-54116741240555 in 1 BOTTLEHistorical
41167-4124-7411674124071 BOTTLE in 1 CARTON (41167-4124-7) > 84 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-02-010000-00-00NoNoCurrent
41167-4124-8411674124081 BOTTLE in 1 CARTON (41167-4124-8) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-05-010000-00-00NoNoCurrent