Allegra Hives 24hr

Product NDC
41167-4126
11-digit product format
411674126
Labeler code
41167
Product ID
41167-4126_942f38c8-c652-49b9-b98f-e8edcf66db1c
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
2022-06-06
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

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 · 3 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
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage41167-412641167-4126-8DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage41167-412641167-4126-8DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage41167-412641167-4126-8DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…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ALLEGRA ALLERGYFEXOFENADINE HYDROCHLORIDE30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2011-01-24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 Hives 24hr
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 · 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
490b4c5f-448b-4563-928b-837117b59b9fAvailable 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
41167-4126-3Allegra Hives 24hr15 in 1 BOTTLETABLET, FILM COATED1510
41167-4126-3Allegra Hives 24hr1 in 1 CARTONTABLET, FILM COATED110
41167-4126-4Allegra Hives 24hr1 in 1 CARTONTABLET, FILM COATED110
41167-4126-4Allegra Hives 24hr30 in 1 BOTTLETABLET, FILM COATED3010
41167-4126-8Allegra Hives 24hr1 in 1 CARTONTABLET, FILM COATED110
41167-4126-8Allegra Hives 24hr5 in 1 BLISTER PACKTABLET, FILM COATED510

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41167-4126-4EA - Each41167-41262e2fdad2-f58a-4b50-9a4b-db9122adef3212023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-4126ALLEGRA HIVES 24HR (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [CHATTEM, INC.]9Current NDC, Legacy NDC, 6 package rows20241127_490b4c5f-448b-4563-928b-837117b59b9f.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
ndc (product): 41167-4126
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 TabletPSN490b4c5f-448b-4563-928b-837117b59b9f10
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN490b4c5f-448b-4563-928b-837117b59b9f10
997422fexofenadine hydrochloride 180 MG Oral Tablet [Allegra]SBD490b4c5f-448b-4563-928b-837117b59b9f10
997420fexofenadine hydrochloride 180 MG Oral TabletSCD490b4c5f-448b-4563-928b-837117b59b9f10
997422Allegra 180 MG Oral TabletSY490b4c5f-448b-4563-928b-837117b59b9f10
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY490b4c5f-448b-4563-928b-837117b59b9f10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41167-4126-3411674126031 BOTTLE in 1 CARTON (41167-4126-3) / 15 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-01-310000-00-00NoNoCurrent
41167-4126-4411674126041 BOTTLE in 1 CARTON (41167-4126-4) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-06-060000-00-00NoNoCurrent
41167-4126-8411674126081 BLISTER PACK in 1 CARTON (41167-4126-8) / 5 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2022-06-060000-00-00NoNoCurrent