Fexofenadine hydrochloride

Product NDC: 55910-111
Requested package NDC: 55910-111-30
11-digit product format: 559100111
Labeler code: 55910
Product ID: 55910-111_70e933f5-e72a-663c-784c-2eb38e453301
Type: HUMAN OTC DRUG
Nonproprietary name: Fexofenadine hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Dollar General
Application: ANDA076502
Marketing category: ANDA
Marketing start: 2019-07-17
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 · 9 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A076502-001	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2006-04-11
A076502-002	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2006-04-11
A076502-003	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2006-04-11
A076502-004	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2011-04-12
A076502-005	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2011-04-12
A076502-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2011-04-12
A076502-007	FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2011-04-12
A076502-008	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2011-04-12
A076502-009	FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2011-04-12

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A076502-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2006-04-11	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076502-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2006-04-11	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076502-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2006-04-11	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076502-004	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2011-04-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076502-005	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2011-04-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076502-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2011-04-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076502-007	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2011-04-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076502-008	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2011-04-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076502-009	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2011-04-12	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 18 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fexofenadine hydrochloride	FEXOFENADINE HYDROCHLORIDE	BluePoint Laboratories	a86aebd0-937e-5d73-e053-2995a90a656a	2026-07-13	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Fexofenadine hydrochloride	FEXOFENADINE HYDROCHLORIDE	Dr. Reddy's Laboratories Limited	864e3052-5787-bf11-9d17-11274ca2304f	2026-07-09	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Dr. Reddy's Laboratories Inc.	b0121213-eae1-8429-9986-3b3b26f35e47	2026-07-09	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Non-Drowsy Allergy Relief	FEXOFENADINE HYDROCHLORIDE	TARGET CORPORATION	3cf4b7fe-b1f7-b767-430a-655408f91753	2025-08-01	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Fexofenadine hydrochloride	FEXOFENADINE HYDROCHLORIDE	MAJOR PHARMACEUTICALS	0a6da401-a8a3-5d0b-f37e-c220838f7e49	2025-07-27	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Fexofenadine hydrochloride	FEXOFENADINE HYDROCHLORIDE	Walgreens Company	b961985e-0c18-b36f-d82e-32ff2d46fada	2025-07-18	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Fexofenadine hydrochloride	FEXOFENADINE HYDROCHLORIDE	Dollar General	1b2a14a1-a5cc-4f5e-8127-57e9d913f50a	2024-11-12	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502 ndc (package): 55910-111-30 ndc (product): 55910-111 ndc11 (package): 55910011130
Fexofenadine hydrochloride	FEXOFENADINE HYDROCHLORIDE	KROGER COMPANY	7b146260-c925-3238-d092-24b7101ceb50	2024-11-12	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Fexofenadine hydrochloride	FEXOFENADINE HYDROCHLORIDE	Dr. Reddy's Laboratories Inc.	624b3a91-af4f-8848-6fc3-392e0df34cc8	2024-11-12	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	CVS Health Corp.	204506d7-7688-fd7e-0aae-142b698848ef	2024-11-12	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Strategic Sourcing Services, LLC	de438313-9790-b4ea-2d28-7a19836cf5e2	2023-04-21	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	Rite Aid Corporation	af2ef0bf-6cd2-b9a6-ff8f-6f50aac152ce	2022-06-12	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Wal-Fex	FEXOFENADINE HYDROCHLORIDE	Walgreens Company	95d420ea-6337-304f-54c3-0c75be1608e2	2022-01-22	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	Family Dollar Stores, Inc.	f532e9d5-6457-8bef-e83e-16050f20b03c	2020-02-19	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Sam's West Inc.	1c1f43c4-7128-37c4-83fe-7eefac3fd477	2019-10-07	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	Safeway Inc	3c30a1dc-a13d-2522-d4d0-00c1e9dbab07	2017-12-11	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Chain Drug Consortium, LLC	d1d8d0ec-2bdd-fb07-a051-d6353e3c240c	2014-01-22	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Chain Drug Marketing Associate	8a1de8a1-808a-bc08-6c74-957d6f388eab	2014-01-22	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502

Additional Listing Data#

Finished product: Yes
Brand name base: Fexofenadine hydrochloride
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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
997420	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
1b2a14a1-a5cc-4f5e-8127-57e9d913f50a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55910-111-30	Fexofenadine hydrochloride	30 in 1 BOTTLE	TABLET	30		7
55910-111-30	Fexofenadine hydrochloride	1 in 1 CARTON	TABLET	1		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55910-111	FEXOFENADINE HYDROCHLORIDE TABLET [DOLLAR GENERAL ]	7	Current NDC, Legacy NDC, 2 package rows	20241114_1b2a14a1-a5cc-4f5e-8127-57e9d913f50a.zip

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
997420	fexofenadine HCl 180 MG 24 HR Oral Tablet	PSN	1b2a14a1-a5cc-4f5e-8127-57e9d913f50a	7
997420	fexofenadine hydrochloride 180 MG Oral Tablet	SCD	1b2a14a1-a5cc-4f5e-8127-57e9d913f50a	7
997420	fexofenadine HCl 180 MG 24 HR Oral Tablet	SY	1b2a14a1-a5cc-4f5e-8127-57e9d913f50a	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55910-111-30	55910011130	1 BOTTLE in 1 CARTON (55910-111-30) / 30 TABLET in 1 BOTTLE	1 bottle	2019-07-17	0000-00-00	No	No	Current