Allegra Allergy

Product NDC
41167-4122
11-digit product format
411674122
Labeler code
41167
Product ID
41167-4122_9bcf6745-5989-41ba-beef-1108fcecc020
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Chattem, Inc.
Application
NDA020872
Marketing category
NDA
Marketing start
2014-12-17
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
2026-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage41167-412241167-4122-6DDiscontinued by firm2026-08-17
excluded packagepackage41167-412241167-4122-9DDiscontinued by firm2026-08-17

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 · 18 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0541167-4122-9d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0541167-4122-6d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2641167-4122-9f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2641167-4122-6f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3141167-4122-92ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3141167-4122-62ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2841167-4122-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2841167-4122-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2141167-4122-9cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2141167-4122-6cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1041167-4122-9cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1041167-4122-6cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3141167-4122-9302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2041167-4122-9ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1041167-4122-90efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0841167-4122-9ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0341167-4122-9367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0941167-4122-9557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 252 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N020872-005CHILDREN'S ALLEGRA ALLERGY30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2011-01-24caaa826d4ba7…
2026-08-18 06:07:402026-07N020872-006CHILDREN'S ALLEGRA HIVES30MGTABLET / ORALRLD2011-01-24caaa826d4ba7…
2026-08-18 06:07:402026-07N020872-007ALLEGRA ALLERGY60MGTABLET / ORALRLD2011-01-24caaa826d4ba7…
2026-08-18 06:07:402026-07N020872-008ALLEGRA HIVES60MGTABLET / ORALRLD2011-01-24caaa826d4ba7…
2026-08-18 06:07:402026-07N020872-009ALLEGRA HIVES180MGTABLET / ORALRLD, RS2011-01-24caaa826d4ba7…
2026-08-18 06:07:402026-07N020872-010ALLEGRA ALLERGY180MGTABLET / ORALRLD, RS2011-01-24caaa826d4ba7…
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…

Additional Listing Data#

Finished product
Yes
Brand name base
Allegra Allergy
Listing expiration
2026-12-31

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 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f061d6b1-89f7-4d5f-ac59-9c73408517c1Available 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
41167-4122-0Allegra Allergy8 in 1 BLISTER PACKTABLET, COATED819
41167-4122-0Allegra Allergy1 in 1 CARTONTABLET, COATED119
41167-4122-2Allegra Allergy60 in 1 BOTTLETABLET, COATED6019
41167-4122-2Allegra Allergy1 in 1 CARTONTABLET, COATED119
41167-4122-5Allegra Allergy24 in 1 BOTTLETABLET, COATED2419
41167-4122-5Allegra Allergy1 in 1 CARTONTABLET, COATED119
41167-4122-6Allegra Allergy32 in 1 BOTTLETABLET, COATED3219
41167-4122-6Allegra Allergy1 in 1 CARTONTABLET, COATED119
41167-4122-7Allegra Allergy40 in 1 BOTTLETABLET, COATED4019
41167-4122-9Allegra Allergy2 in 1 CARTONTABLET, COATED219

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41167-4122-0EA - Each41167-41223a35f0a5-0516-4e29-a8f2-88da4f8235ce12018-03-08
41167-4122-2EA - Each41167-41222518db29-f05b-49ba-a278-8aa86851b90312017-05-03
41167-4122-5EA - Each41167-4122f8d82f4f-f62c-48b9-b277-51aac0b33b2d12022-09-12
41167-4122-6EA - Each41167-41227928dbf2-5442-4ea3-a8ce-e360da62ca5d12022-09-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZUALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, COATED [CHATTEM, INC.]5
FEXOFENADINEACTIVE MOIETYE6582LOH6VALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, COATED [CHATTEM, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, COATED [CHATTEM, INC.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, COATED [CHATTEM, INC.]5
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, COATED [CHATTEM, INC.]5
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, COATED [CHATTEM, INC.]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, COATED [CHATTEM, INC.]5
GELATININACTIVE INGREDIENT2G86QN327LALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, COATED [CHATTEM, INC.]5
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, COATED [CHATTEM, INC.]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, COATED [CHATTEM, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, COATED [CHATTEM, INC.]5
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, COATED [CHATTEM, INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, COATED [CHATTEM, INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, COATED [CHATTEM, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-4122ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, COATED [CHATTEM, INC.]19Current NDC, Legacy NDC, 10 package rows20250221_f061d6b1-89f7-4d5f-ac59-9c73408517c1.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
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
ndc (product): 41167-4122
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 TabletPSNf061d6b1-89f7-4d5f-ac59-9c73408517c119
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNf061d6b1-89f7-4d5f-ac59-9c73408517c119
997422fexofenadine hydrochloride 180 MG Oral Tablet [Allegra]SBDf061d6b1-89f7-4d5f-ac59-9c73408517c119
997420fexofenadine hydrochloride 180 MG Oral TabletSCDf061d6b1-89f7-4d5f-ac59-9c73408517c119
997422Allegra 180 MG Oral TabletSYf061d6b1-89f7-4d5f-ac59-9c73408517c119
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYf061d6b1-89f7-4d5f-ac59-9c73408517c119

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41167-4122-0411674122001 BLISTER PACK in 1 CARTON (41167-4122-0) / 8 TABLET, COATED in 1 BLISTER PACK1 blister pack2014-12-170000-00-00NoNoCurrent
41167-4122-2411674122021 BOTTLE in 1 CARTON (41167-4122-2) / 60 TABLET, COATED in 1 BOTTLE1 bottle2014-12-170000-00-00NoNoCurrent
41167-4122-5411674122051 BOTTLE in 1 CARTON (41167-4122-5) / 24 TABLET, COATED in 1 BOTTLE1 bottle2014-12-170000-00-00NoNoCurrent
41167-4122-6411674122061 BOTTLE in 1 CARTON (41167-4122-6) > 32 TABLET, COATED in 1 BOTTLE1 bottle2014-12-170000-00-00NoNoCurrent
41167-4122-74116741220740 in 1 BOTTLEHistorical
41167-4122-9411674122092 in 1 CARTONHistorical