Allergy Relief

Product NDC: 37808-571
Requested package NDC: 37808-571-95
11-digit product format: 378080571
Labeler code: 37808
Product ID: 37808-571_0e4ad335-1644-4143-84f3-acccf9bc84f9
Type: HUMAN OTC DRUG
Nonproprietary name: fexofenadine hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: H E B
Application: ANDA076447
Marketing category: ANDA
Marketing start: 2011-06-22
Marketing end: 0000-00-00
Substance: FEXOFENADINE HYDROCHLORIDE
Active strength: 180 mg/1
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	37808-571	37808-571-95	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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	37808-571	37808-571-95	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	37808-571	37808-571-95	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A076447-001	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2005-09-01
A076447-002	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2005-09-01
A076447-003	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2005-09-01
A076447-004	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2011-04-13
A076447-005	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2011-04-13
A076447-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2011-04-13
A076447-007	FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2011-04-13
A076447-008	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2011-04-13

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 9 · 328 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076447-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2005-09-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076447-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2005-09-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076447-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	AB	2005-09-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076447-004	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL		2011-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076447-005	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL		2011-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076447-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL		2011-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076447-007	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL		2011-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076447-008	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL		2011-04-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076447-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2005-09-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076447-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2005-09-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076447-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	AB	2005-09-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076447-004	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL		2011-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076447-005	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL		2011-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076447-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL		2011-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076447-007	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL		2011-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076447-008	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL		2011-04-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076447-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2005-09-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076447-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2005-09-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076447-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	AB	2005-09-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076447-004	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL		2011-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076447-005	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL		2011-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076447-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL		2011-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076447-007	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL		2011-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076447-008	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL		2011-04-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076447-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2005-09-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076447-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2005-09-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076447-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	AB	2005-09-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076447-004	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL		2011-04-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076447-005	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL		2011-04-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076447-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL		2011-04-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076447-007	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL		2011-04-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076447-008	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL		2011-04-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076447-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2005-09-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076447-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2005-09-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076447-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	AB	2005-09-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076447-004	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL		2011-04-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076447-005	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL		2011-04-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076447-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL		2011-04-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076447-007	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL		2011-04-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076447-008	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL		2011-04-13	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076447-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076447-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076447-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076447-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076447-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076447-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076447-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076447-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076447-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076447-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076447-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076447-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076447-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076447-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076447-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076447-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076447-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076447-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076447-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076447-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076447-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076447-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076447-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076447-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076447-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076447-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076447-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076447-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076447-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076447-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076447-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076447-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076447-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076447-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076447-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076447-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076447-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076447-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076447-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076447-001	AB	1	`8072bd15b7f6…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
37808-571-22	2021-11-14	HEB Allergy Relief Drug Facts
37808-571-39	2021-11-14	HEB Allergy Relief Drug Facts
37808-571-49	2021-11-14	HEB Allergy Relief Drug Facts
37808-571-95	2021-11-14	HEB Allergy Relief Drug Facts
37808-571-22	2021-07-23	HEB Allergy Relief Drug Facts
37808-571-39	2021-07-23	HEB Allergy Relief Drug Facts
37808-571-49	2021-07-23	HEB Allergy Relief Drug Facts
37808-571-95	2021-07-23	HEB Allergy Relief Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
37808-571-22	EA - Each	37808-571	656ff02f-a0fc-44ee-8abc-da66b6cdc776	1	2022-06-06
37808-571-39	EA - Each	37808-571	87d224e7-3cdb-480a-925f-5c618635bbf7	1	2022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FEXOFENADINE HYDROCHLORIDE	ACTIVE INGREDIENT	2S068B75ZU	ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]	3
FEXOFENADINE	ACTIVE MOIETY	E6582LOH6V	ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]	3
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
37808-571	ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]	7	Legacy NDC	20211115_5bd44447-3c29-40ee-8326-cf7092464c89.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CareOne Allergy Relief	FEXOFENADINE HCL	American Sales Company	65720e72-c20d-4363-92ab-76596e043bc0	2021-07-12	Warnings	Exact identifier application applno (ANDA): 076447 application number: ANDA076447

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
37808-571-95	37808057195	1 BOTTLE in 1 CARTON (37808-571-95) > 45 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2012-10-01	0000-00-00	No	No	Current