ALLEGRA ALLERGY

Product NDC: 50090-1234
11-digit product format: 500901234
Labeler code: 50090
Product ID: 50090-1234_9840fda7-e713-4573-8029-046a50c67462
Type: HUMAN OTC DRUG
Nonproprietary name: fexofenadine hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: NDA020872
Marketing category: NDA
Marketing start: 2011-03-03
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

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ALLEGRA ALLERGY	FEXOFENADINE HYDROCHLORIDE	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2011-01-24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2026-02	N020872-005	CHILDREN'S ALLEGRA ALLERGY	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2011-01-24	`011fe1cb6892…`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: 2026-12-31

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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
997420	Internal RxNorm lookup
997422	Internal RxNorm lookup
997501	Internal RxNorm lookup
997502	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
b5ce28f8-f6c3-4113-9317-e1c98e5030ef	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-1234-0	2023-02-06	C162847	48780-1	f386c649-f187-0266-e053-dadaa90a7c1a	ALLEGRA ALLERGY
50090-1234-0	2023-01-30	C162847	48780-1	f386c649-f187-0266-e053-dadaa90a7c1a	ALLEGRA ALLERGY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-1234-0	ALLEGRA ALLERGY	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30		24
50090-1234-0	ALLEGRA ALLERGY	1 in 1 CARTON	TABLET, FILM COATED	1		24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-1234-0	EA - Each	50090-1234	cf39ccac-8da4-4e2a-9a77-a4d90a8e9d7c	1	2018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-1234	ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]	24	Current NDC, Legacy NDC, 2 package rows	20240731_b5ce28f8-f6c3-4113-9317-e1c98e5030ef.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
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 ndc (product): 50090-1234

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	b5ce28f8-f6c3-4113-9317-e1c98e5030ef	24
997502	Allegra Allergy 60 MG Oral Tablet	PSN	b5ce28f8-f6c3-4113-9317-e1c98e5030ef	24
997420	fexofenadine HCl 180 MG 24 HR Oral Tablet	PSN	b5ce28f8-f6c3-4113-9317-e1c98e5030ef	24
997501	fexofenadine HCl 60 MG Oral Tablet	PSN	b5ce28f8-f6c3-4113-9317-e1c98e5030ef	24
997422	fexofenadine hydrochloride 180 MG Oral Tablet [Allegra]	SBD	b5ce28f8-f6c3-4113-9317-e1c98e5030ef	24
997502	fexofenadine hydrochloride 60 MG Oral Tablet [Allegra]	SBD	b5ce28f8-f6c3-4113-9317-e1c98e5030ef	24
997420	fexofenadine hydrochloride 180 MG Oral Tablet	SCD	b5ce28f8-f6c3-4113-9317-e1c98e5030ef	24
997501	fexofenadine hydrochloride 60 MG Oral Tablet	SCD	b5ce28f8-f6c3-4113-9317-e1c98e5030ef	24
997422	Allegra 180 MG Oral Tablet	SY	b5ce28f8-f6c3-4113-9317-e1c98e5030ef	24
997502	Allegra 60 MG Oral Tablet	SY	b5ce28f8-f6c3-4113-9317-e1c98e5030ef	24
997420	fexofenadine HCl 180 MG 24 HR Oral Tablet	SY	b5ce28f8-f6c3-4113-9317-e1c98e5030ef	24

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-1234-0	50090123400	1 BOTTLE, PLASTIC in 1 CARTON (50090-1234-0) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC	2014-11-28	0000-00-00	No	No	Current