Childrens Allegra Allergy

Product NDC
41167-4232
11-digit product format
411674232
Labeler code
41167
Product ID
41167-4232_44cdb5d9-8c36-41e1-af5a-35983ab0cc52
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine Hydrochloride
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Chattem, Inc.
Application
NDA021909
Marketing category
NDA
Marketing start
2014-01-02
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
30 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage41167-423241167-4232-1DDiscontinued 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 · 6 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…

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021909-002CHILDREN'S ALLEGRA ALLERGYFEXOFENADINE HYDROCHLORIDE30MGTABLET, ORALLY DISINTEGRATING / ORALRLD2011-01-24
N021909-003CHILDREN'S ALLEGRA HIVESFEXOFENADINE HYDROCHLORIDE30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2011-01-24

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N021909-002CHILDREN'S ALLEGRA ALLERGY30MGTABLET, ORALLY DISINTEGRATING / ORALRLD2011-01-24caaa826d4ba7…
2026-08-18 06:07:402026-07N021909-003CHILDREN'S ALLEGRA HIVES30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2011-01-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021909-002CHILDREN'S ALLEGRA ALLERGY30MGTABLET, ORALLY DISINTEGRATING / ORALRLD2011-01-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021909-003CHILDREN'S ALLEGRA HIVES30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2011-01-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021909-002CHILDREN'S ALLEGRA ALLERGY30MGTABLET, ORALLY DISINTEGRATING / ORALRLD2011-01-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021909-003CHILDREN'S ALLEGRA HIVES30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2011-01-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N021909-002CHILDREN'S ALLEGRA ALLERGY30MGTABLET, ORALLY DISINTEGRATING / ORALRLD2011-01-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021909-003CHILDREN'S ALLEGRA HIVES30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2011-01-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021909-002CHILDREN'S ALLEGRA ALLERGY30MGTABLET, ORALLY DISINTEGRATING / ORALRLD2011-01-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021909-003CHILDREN'S ALLEGRA HIVES30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2011-01-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021909-002CHILDREN'S ALLEGRA ALLERGY30MGTABLET, ORALLY DISINTEGRATING / ORALRLD2011-01-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021909-003CHILDREN'S ALLEGRA HIVES30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2011-01-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021909-002CHILDREN'S ALLEGRA ALLERGY30MGTABLET, ORALLY DISINTEGRATING / ORALRLD2011-01-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021909-003CHILDREN'S ALLEGRA HIVES30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2011-01-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021909-002CHILDREN'S ALLEGRA ALLERGY30MGTABLET, ORALLY DISINTEGRATING / ORALRLD2011-01-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021909-003CHILDREN'S ALLEGRA HIVES30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2011-01-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021909-002CHILDREN'S ALLEGRA ALLERGY30MGTABLET, ORALLY DISINTEGRATING / ORALRLD2011-01-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021909-003CHILDREN'S ALLEGRA HIVES30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2011-01-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021909-002CHILDREN'S ALLEGRA ALLERGY30MGTABLET, ORALLY DISINTEGRATING / ORALRLD2011-01-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021909-003CHILDREN'S ALLEGRA HIVES30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2011-01-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021909-002CHILDREN'S ALLEGRA ALLERGY30MGTABLET, ORALLY DISINTEGRATING / ORALRLD2011-01-24d06236e962d9…
2024-10-29 15:01 UTC2024-10N021909-003CHILDREN'S ALLEGRA HIVES30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2011-01-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021909-002CHILDREN'S ALLEGRA ALLERGY30MGTABLET, ORALLY DISINTEGRATING / ORALRLD2011-01-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021909-003CHILDREN'S ALLEGRA HIVES30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2011-01-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021909-002CHILDREN'S ALLEGRA ALLERGY30MGTABLET, ORALLY DISINTEGRATING / ORALRLD2011-01-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021909-003CHILDREN'S ALLEGRA HIVES30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2011-01-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021909-002CHILDREN'S ALLEGRA ALLERGY30MGTABLET, ORALLY DISINTEGRATING / ORALRLD2011-01-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021909-003CHILDREN'S ALLEGRA HIVES30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2011-01-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021909-002CHILDREN'S ALLEGRA ALLERGY30MGTABLET, ORALLY DISINTEGRATING / ORALRLD2011-01-248072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021909-003CHILDREN'S ALLEGRA HIVES30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2011-01-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021909-002CHILDREN'S ALLEGRA ALLERGY30MGTABLET, ORALLY DISINTEGRATING / ORALRLD2011-01-245c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021909-003CHILDREN'S ALLEGRA HIVES30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2011-01-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021909-002CHILDREN'S ALLEGRA ALLERGY30MGTABLET, ORALLY DISINTEGRATING / ORALRLD2011-01-245d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021909-003CHILDREN'S ALLEGRA HIVES30MGTABLET, ORALLY DISINTEGRATING / ORALRLD2011-01-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021909-002CHILDREN'S ALLEGRA ALLERGY30MGTABLET, ORALLY DISINTEGRATING / ORALRLD2011-01-244b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021909-003CHILDREN'S ALLEGRA HIVES30MGTABLET, ORALLY DISINTEGRATING / ORALRLD2011-01-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021909-002CHILDREN'S ALLEGRA ALLERGY30MGTABLET, ORALLY DISINTEGRATING / ORALRLD2011-01-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021909-003CHILDREN'S ALLEGRA HIVES30MGTABLET, ORALLY DISINTEGRATING / ORALRLD2011-01-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021909-002CHILDREN'S ALLEGRA ALLERGY30MGTABLET, ORALLY DISINTEGRATING / ORALRLD2011-01-24bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021909-003CHILDREN'S ALLEGRA HIVES30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2011-01-24bb7c543d1eb4…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021909-00267233482021-11-26U-1466Drug product2013-12-1874a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021909-00367233482021-11-26Drug product2013-12-1874a2ff9319b5…
2021-12-28 21:50 UTC2021-12N021909-00267233482021-11-26U-1466Drug product2013-12-18782e0a99824c…
2021-12-28 21:50 UTC2021-12N021909-00367233482021-11-26Drug product2013-12-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021909-00267233482021-11-26U-1466Drug product2013-12-1887673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021909-00367233482021-11-26Drug product2013-12-1887673890dc5c…
2021-03-12 10:30 UTC2021-03N021909-00267233482021-11-26U-1466Drug product2013-12-185aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021909-00367233482021-11-26Drug product2013-12-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021909-00267233482021-11-26U-1466Drug product2013-12-188869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021909-00367233482021-11-26Drug product2013-12-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021909-00267233482021-11-26U-1466Drug product2013-12-18c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021909-00367233482021-11-26Drug product2013-12-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021909-00267233482021-11-26U-1466Drug product2013-12-183f01610625f2…
2019-12-14 00:12 UTC2019-12N021909-00367233482021-11-26Drug product2013-12-183f01610625f2…
2019-09-15 20:21 UTC2019-09N021909-00267233482021-11-26U-1466Drug product2013-12-18b00525d2431f…
2019-09-15 20:21 UTC2019-09N021909-00367233482021-11-26Drug product2013-12-18b00525d2431f…
2019-07-19 19:46 UTC2019-07N021909-00267233482021-11-26U-1466Drug product2013-12-18ea99ee380514…
2019-07-19 19:46 UTC2019-07N021909-00367233482021-11-26Drug product2013-12-18ea99ee380514…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FEXOFENADINE HYDROCHLORIDE30 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
997482Internal RxNorm lookup
997484Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
06115cea-5a44-409d-85ed-bb71743491c1Available 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
41167-4232-1Childrens Allegra Allergy6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING616
41167-4232-1Childrens Allegra Allergy2 in 1 CARTONTABLET, ORALLY DISINTEGRATING216
41167-4232-6Childrens Allegra Allergy6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING616
41167-4232-6Childrens Allegra Allergy4 in 1 CARTONTABLET, ORALLY DISINTEGRATING416

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41167-4232-1EA - Each41167-42326d240a7a-34be-4ec9-8d4e-64c16914377c12014-07-02
41167-4232-6EA - Each41167-4232ade41b16-b68e-4f99-accc-afc2032c379812016-05-16

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-4232CHILDRENS ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [CHATTEM, INC.]16Current NDC, Legacy NDC, 4 package rows20250216_06115cea-5a44-409d-85ed-bb71743491c1.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
Childrens Allegra AllergyFEXOFENADINE HYDROCHLORIDEChattem, Inc.06115cea-5a44-409d-85ed-bb71743491c12025-02-18WarningsExact identifier
application applno (NDA): 021909
application number: NDA021909
ndc (product): 41167-4232

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997484Childrens Allegra Allergy 30 MG Disintegrating Oral TabletPSN06115cea-5a44-409d-85ed-bb71743491c116
997482fexofenadine HCl 30 MG Disintegrating Oral TabletPSN06115cea-5a44-409d-85ed-bb71743491c116
997484fexofenadine hydrochloride 30 MG Disintegrating Oral Tablet [Allegra]SBD06115cea-5a44-409d-85ed-bb71743491c116
997482fexofenadine hydrochloride 30 MG Disintegrating Oral TabletSCD06115cea-5a44-409d-85ed-bb71743491c116
997484Allegra 30 MG Disintegrating Oral TabletSY06115cea-5a44-409d-85ed-bb71743491c116

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41167-4232-1411674232012 BLISTER PACK in 1 CARTON (41167-4232-1) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK2 blister pack2014-01-020000-00-00NoNoCurrent
41167-4232-6411674232064 BLISTER PACK in 1 CARTON (41167-4232-6) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK4 blister pack2014-01-020000-00-00NoNoCurrent