Allegra Allergy

Product NDC
66715-9707
11-digit product format
667159707
Labeler code
66715
Product ID
66715-9707_5076f5eb-2ebc-5623-e063-6394a90a3fff
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lil' Drug Store Products, Inc
Application
NDA020872
Marketing category
NDA
Marketing start
2014-09-01
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

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ALLEGRA ALLERGYFEXOFENADINE HYDROCHLORIDE30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2011-01-24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ALLEGRA ALLERGY30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2011-01-24011fe1cb6892…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 · 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
b82d993a-16ff-4037-a182-7010de8e1cddAvailable 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
66715-9707-1Allegra Allergy1 in 1 CARTONTABLET, FILM COATED19
66715-9707-1Allegra Allergy1 in 1 BLISTER PACKTABLET, FILM COATED19
66715-9707-2Allegra Allergy1 in 1 BLISTER PACKTABLET, FILM COATED19
66715-9707-2Allegra Allergy2 in 1 CARTONTABLET, FILM COATED29
66715-9707-8Allegra Allergy5 in 1 CARTONTABLET, FILM COATED59
66715-9707-8Allegra Allergy1 in 1 BLISTER PACKTABLET, FILM COATED19

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-9707ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED ALLEGRA ALLERGY, TRAVEL BASIX (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC]8Current NDC, Legacy NDC, 6 package rows20241121_b82d993a-16ff-4037-a182-7010de8e1cdd.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
ndc (product): 66715-9707
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
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 TabletPSNb82d993a-16ff-4037-a182-7010de8e1cdd9
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNb82d993a-16ff-4037-a182-7010de8e1cdd9
997422fexofenadine hydrochloride 180 MG Oral Tablet [Allegra]SBDb82d993a-16ff-4037-a182-7010de8e1cdd9
997420fexofenadine hydrochloride 180 MG Oral TabletSCDb82d993a-16ff-4037-a182-7010de8e1cdd9
997422Allegra 180 MG Oral TabletSYb82d993a-16ff-4037-a182-7010de8e1cdd9
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYb82d993a-16ff-4037-a182-7010de8e1cdd9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66715-9707-1667159707011 BLISTER PACK in 1 CARTON (66715-9707-1) / 1 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2018-11-010000-00-00NoNoCurrent
66715-9707-2667159707022 BLISTER PACK in 1 CARTON (66715-9707-2) / 1 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2018-11-010000-00-00NoNoCurrent
66715-9707-8667159707085 BLISTER PACK in 1 CARTON (66715-9707-8) / 1 TABLET, FILM COATED in 1 BLISTER PACK5 blister pack2018-11-010000-00-00NoNoCurrent