Allergy Relief

Product NDC: 80539-801
11-digit product format: 805390801
Labeler code: 80539
Product ID: 80539-801_85a61c72-ee48-48e2-93c7-3e341f7cbad1
Type: HUMAN OTC DRUG
Nonproprietary name: Fexofenadine HCl
Dosage form: TABLET
Route: ORAL
Labeler: Allwell Health Inc
Application: ANDA211075
Marketing category: ANDA
Marketing start: 2021-01-29
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	80539-801		D	Discontinued by firm		2026-10-16
excluded package	package	80539-801	80539-801-30	D	Discontinued by firm		2026-10-16

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 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80539-801-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80539-801-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80539-801-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80539-801-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80539-801-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80539-801-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	80539-801-30	`302b2466d912…`	`e7b80fea0513…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL			2019-10-18
A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL			2019-10-18

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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`4b0b4de00fa7…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 2 of 3 · 55 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fexofenadine HCL	FEXOFENADINE HCL	Walgreens	0eaf28a5-f8dd-3888-e063-6394a90a8cc6	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Fexofenadine HCl	FEXOFENADINE HCL	Rite Aid	1dd9affe-b55d-e1fb-e063-6394a90a7794	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Fexofenadine HCl	FEXOFENADINE HCL	Rite Aid	1dda06c9-8e0f-38d7-e063-6394a90aba3e	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Fexofenadine HCl	FEXOFENADINE HCL	Rite Aid	1ddad045-7706-ea7e-e063-6394a90a2a5a	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Fexofenadine HCl	FEXOFENADINE HCL	Rite Aid	1ddae2a1-0e16-e294-e063-6394a90a05f5	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Fexofenadine HCl	FEXOFENADINE HCL	Rite Aid	1ddb1716-9c5b-6348-e063-6394a90acbf1	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Cabinet Allergy Relief Fexofenadine	FEXOFENADINE HYDROCHLORIDE	Cabinet Health P.B.C.	9ed710e1-47f4-4d04-a509-12c8c97c192c	2025-11-05	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
ValuMeds 24-Hour Allergy Relief	FEXOFENADINE HYDROCHLORIDE	Cabinet Health P.B.C.	036f8eaa-7eb9-46f4-b42e-3c8c7e49e450	2025-10-23	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Cabinet Allergy Relief Fexofenadine	FEXOFENADINE HYDROCHLORIDE	Cabinet Health P.B.C.	5237c8bd-0b20-4639-a740-f3001c4c2c94	2025-10-22	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	FSA STORE INC.	276e9767-93c0-5932-e063-6394a90ab2d9	2025-03-07	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Fexofenadine HCL	FEXOFENADINE HCL	Walgreens	fd7920f6-f53e-90cf-e053-6294a90aa8db	2024-12-16	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	HARRIS TEETER	c4f9e849-f286-4167-e053-2a95a90a38f9	2024-10-11	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	c5d58d74-da08-eb72-e053-2a95a90adc27	2024-10-11	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	5059ffc9-b116-4d11-9678-56c696f4e3db	2024-08-16	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Granules India Limited	1d46555d-827b-b154-e063-6294a90ad3d5	2024-08-08	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	AAA PHARMACEUTICAL, INC.	c547c163-2a19-10d8-e053-2a95a90ac817	2024-07-24	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	Safeway, Inc.	348b79cf-1184-46d4-a0e5-fdc24afec1a5	2024-02-09	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	AMERIFOODS TRADING COMPANY	f6dc0893-b81b-4f96-e053-6294a90a856f	2023-11-02	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	c4f9224c-4c3d-74bd-e053-2995a90a1452	2023-10-30	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	Chain Drug Marketing Association, Inc.	fabb8c0d-b4da-ab73-e053-6394a90ab8b5	2023-05-22	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
80539-801-30	80539080130	1 BOTTLE, PLASTIC in 1 BOX (80539-801-30) > 30 TABLET in 1 BOTTLE, PLASTIC	2021-01-29	0000-00-00	No	No	Current