Allegra Allergy

Product NDC: 67751-033
11-digit product format: 677510033
Labeler code: 67751
Product ID: 67751-033_50105c7e-4025-1a55-e063-6394a90a88b4
Type: HUMAN OTC DRUG
Nonproprietary name: FEXOFENADINE HYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Navajo Manufacturing Company Inc.
Application: NDA020872
Marketing category: NDA
Marketing start: 2015-05-12
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	67751-033	67751-033-01	D	Discontinued by firm		2026-08-11

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 date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`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-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N020872-005	CHILDREN'S ALLEGRA ALLERGY	FEXOFENADINE HYDROCHLORIDE	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2011-01-24
N020872-006	CHILDREN'S ALLEGRA HIVES	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	RLD	2011-01-24
N020872-007	ALLEGRA ALLERGY	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	RLD	2011-01-24
N020872-008	ALLEGRA HIVES	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	RLD	2011-01-24
N020872-009	ALLEGRA HIVES	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	RLD, RS	2011-01-24
N020872-010	ALLEGRA ALLERGY	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	RLD, RS	2011-01-24

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020872-005	CHILDREN'S ALLEGRA ALLERGY	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2011-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020872-006	CHILDREN'S ALLEGRA HIVES	30MG	TABLET / ORAL	RLD	2011-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020872-007	ALLEGRA ALLERGY	60MG	TABLET / ORAL	RLD	2011-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020872-008	ALLEGRA HIVES	60MG	TABLET / ORAL	RLD	2011-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020872-009	ALLEGRA HIVES	180MG	TABLET / ORAL	RLD, RS	2011-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020872-010	ALLEGRA ALLERGY	180MG	TABLET / ORAL	RLD, RS	2011-01-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020872-005	CHILDREN'S ALLEGRA ALLERGY	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2011-01-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020872-006	CHILDREN'S ALLEGRA HIVES	30MG	TABLET / ORAL	RLD	2011-01-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020872-007	ALLEGRA ALLERGY	60MG	TABLET / ORAL	RLD	2011-01-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020872-008	ALLEGRA HIVES	60MG	TABLET / ORAL	RLD	2011-01-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020872-009	ALLEGRA HIVES	180MG	TABLET / ORAL	RLD, RS	2011-01-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020872-010	ALLEGRA ALLERGY	180MG	TABLET / ORAL	RLD, RS	2011-01-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020872-005	CHILDREN'S ALLEGRA ALLERGY	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2011-01-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020872-006	CHILDREN'S ALLEGRA HIVES	30MG	TABLET / ORAL	RLD	2011-01-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020872-007	ALLEGRA ALLERGY	60MG	TABLET / ORAL	RLD	2011-01-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020872-008	ALLEGRA HIVES	60MG	TABLET / ORAL	RLD	2011-01-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020872-009	ALLEGRA HIVES	180MG	TABLET / ORAL	RLD, RS	2011-01-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020872-010	ALLEGRA ALLERGY	180MG	TABLET / ORAL	RLD, RS	2011-01-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020872-005	CHILDREN'S ALLEGRA ALLERGY	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2011-01-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020872-006	CHILDREN'S ALLEGRA HIVES	30MG	TABLET / ORAL	RLD	2011-01-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020872-007	ALLEGRA ALLERGY	60MG	TABLET / ORAL	RLD	2011-01-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020872-008	ALLEGRA HIVES	60MG	TABLET / ORAL	RLD	2011-01-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020872-009	ALLEGRA HIVES	180MG	TABLET / ORAL	RLD, RS	2011-01-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020872-010	ALLEGRA ALLERGY	180MG	TABLET / ORAL	RLD, RS	2011-01-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020872-005	CHILDREN'S ALLEGRA ALLERGY	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2011-01-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020872-006	CHILDREN'S ALLEGRA HIVES	30MG	TABLET / ORAL	RLD	2011-01-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020872-007	ALLEGRA ALLERGY	60MG	TABLET / ORAL	RLD	2011-01-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020872-008	ALLEGRA HIVES	60MG	TABLET / ORAL	RLD	2011-01-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020872-009	ALLEGRA HIVES	180MG	TABLET / ORAL	RLD, RS	2011-01-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020872-010	ALLEGRA ALLERGY	180MG	TABLET / ORAL	RLD, RS	2011-01-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020872-005	CHILDREN'S ALLEGRA ALLERGY	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2011-01-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020872-006	CHILDREN'S ALLEGRA HIVES	30MG	TABLET / ORAL	RLD	2011-01-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020872-007	ALLEGRA ALLERGY	60MG	TABLET / ORAL	RLD	2011-01-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020872-008	ALLEGRA HIVES	60MG	TABLET / ORAL	RLD	2011-01-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020872-009	ALLEGRA HIVES	180MG	TABLET / ORAL	RLD, RS	2011-01-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020872-010	ALLEGRA ALLERGY	180MG	TABLET / ORAL	RLD, RS	2011-01-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020872-005	CHILDREN'S ALLEGRA ALLERGY	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2011-01-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020872-006	CHILDREN'S ALLEGRA HIVES	30MG	TABLET / ORAL	RLD	2011-01-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020872-007	ALLEGRA ALLERGY	60MG	TABLET / ORAL	RLD	2011-01-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020872-008	ALLEGRA HIVES	60MG	TABLET / ORAL	RLD	2011-01-24	`2680178bc6a6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FEXOFENADINE HYDROCHLORIDE	180 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2S068B75ZU	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
e8a00fa1-79af-4ce6-885f-0ce12c5da836	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67751-033-01	Allegra Allergy	1 in 1 BLISTER PACK	TABLET, FILM COATED	1	8
67751-033-02	Allegra Allergy	1 in 1 BLISTER PACK	TABLET, FILM COATED	1	8
67751-033-02	Allegra Allergy	1 in 1 CARTON	TABLET, FILM COATED	1	8

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FEXOFENADINE HYDROCHLORIDE	ACTIVE INGREDIENT	2S068B75ZU	ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET [NAVAJO MANUFACTURING CO., INC.]	1
FEXOFENADINE	ACTIVE MOIETY	E6582LOH6V	ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET [NAVAJO MANUFACTURING CO., INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET [NAVAJO MANUFACTURING CO., INC.]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET [NAVAJO MANUFACTURING CO., INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET [NAVAJO MANUFACTURING CO., INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET [NAVAJO MANUFACTURING CO., INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET [NAVAJO MANUFACTURING CO., INC.]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET [NAVAJO MANUFACTURING CO., INC.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET [NAVAJO MANUFACTURING CO., INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET [NAVAJO MANUFACTURING CO., INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67751-033	ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [NAVAJO MANUFACTURING COMPANY INC.]	6	Current NDC, Legacy NDC, 3 package rows	20241004_e8a00fa1-79af-4ce6-885f-0ce12c5da836.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allegra Allergy, Travel BASIX	FEXOFENADINE HYDROCHLORIDE	Lil' Drug Store Products, Inc	b82d993a-16ff-4037-a182-7010de8e1cdd	2026-04-27	Warnings	Exact identifier application applno (NDA): 020872 application number: NDA020872
Allegra Allergy	FEXOFENADINE HYDROCHLORIDE	Navajo Manufacturing Company Inc.	e8a00fa1-79af-4ce6-885f-0ce12c5da836	2026-04-22	Warnings	Exact identifier application applno (NDA): 020872 application number: NDA020872 ndc (product): 67751-033
Allegra Allergy	FEXOFENADINE HYDROCHLORIDE	Chattem, Inc.	81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd173	2026-04-14	Warnings	Exact identifier application applno (NDA): 020872 application number: NDA020872
Allegra Hives 24hr	FEXOFENADINE HYDROCHLORIDE	Chattem, Inc.	490b4c5f-448b-4563-928b-837117b59b9f	2026-01-12	Warnings	Exact identifier application applno (NDA): 020872 application number: NDA020872
Allegra Allergy	FEXOFENADINE HYDROCHLORIDE	Chattem, Inc.	f061d6b1-89f7-4d5f-ac59-9c73408517c1	2025-02-19	Warnings	Exact identifier application applno (NDA): 020872 application number: NDA020872
ALLEGRA ALLERGY	FEXOFENADINE HYDROCHLORIDE	A-S Medication Solutions	b5ce28f8-f6c3-4113-9317-e1c98e5030ef	2024-07-30	Warnings	Exact identifier application applno (NDA): 020872 application number: NDA020872

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2S068B75ZU	FEXOFENADINE HYDROCHLORIDE	153439-40-8	FEXOFENADINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
997422	Allegra 180 MG Oral Tablet	PSN	e8a00fa1-79af-4ce6-885f-0ce12c5da836	8
997420	fexofenadine HCl 180 MG 24 HR Oral Tablet	PSN	e8a00fa1-79af-4ce6-885f-0ce12c5da836	8
997422	fexofenadine hydrochloride 180 MG Oral Tablet [Allegra]	SBD	e8a00fa1-79af-4ce6-885f-0ce12c5da836	8
997420	fexofenadine hydrochloride 180 MG Oral Tablet	SCD	e8a00fa1-79af-4ce6-885f-0ce12c5da836	8
997422	Allegra 180 MG Oral Tablet	SY	e8a00fa1-79af-4ce6-885f-0ce12c5da836	8
997420	fexofenadine HCl 180 MG 24 HR Oral Tablet	SY	e8a00fa1-79af-4ce6-885f-0ce12c5da836	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67751-033-01	67751003301	1 in 1 BLISTER PACK						Historical
67751-033-02	67751003302	1 BLISTER PACK in 1 CARTON (67751-033-02) / 1 TABLET, FILM COATED in 1 BLISTER PACK	1 blister pack	2016-03-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Allegra Allergy	Navajo Manufacturing Company Inc.	2026-04-22	HUMAN OTC DRUG LABEL	8
Allegra Allergy	Navajo Manufacturing Company Inc.	2016-09-23	HUMAN OTC DRUG LABEL	1