Fexofenadine Hydrochloride

Product NDC: 45802-425
11-digit product format: 458020425
Labeler code: 45802
Product ID: 45802-425_9fcaa9c1-55a7-4de0-b69b-ca06a3bf8834
Type: HUMAN OTC DRUG
Nonproprietary name: Fexofenadine HCl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Padagis Israel Pharmaceuticals Ltd
Application: ANDA076447
Marketing category: ANDA
Marketing start: 2011-08-08
Marketing end: 2023-01-01
Substance: FEXOFENADINE HYDROCHLORIDE
Active strength: 60 mg/1
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
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	45802-425		D	Discontinued by firm		2026-08-11
excluded package	package	45802-425	45802-425-78	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 · 24 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	45802-425-78	`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	45802-425-78	`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	45802-425-78	`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	45802-425-78	`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	45802-425-78	`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	45802-425-78	`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	45802-425-78	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45802-425-78	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45802-425-78	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	45802-425-78	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	45802-425-78	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	45802-425-78	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45802-425-78	EA - Each	45802-425	83515b3f-8212-495b-9e2e-9d400c0157dc	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FEXOFENADINE HYDROCHLORIDE	ACTIVE INGREDIENT	2S068B75ZU	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
FEXOFENADINE HYDROCHLORIDE	ACTIVE INGREDIENT	2S068B75ZU	FEXOFENODINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
FEXOFENADINE HYDROCHLORIDE	ACTIVE INGREDIENT	2S068B75ZU	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [PERRIGO NEW YORK INC]	2
FEXOFENADINE	ACTIVE MOIETY	E6582LOH6V	FEXOFENODINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
FEXOFENADINE	ACTIVE MOIETY	E6582LOH6V	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [PERRIGO NEW YORK INC]	2
FEXOFENADINE	ACTIVE MOIETY	E6582LOH6V	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [PERRIGO NEW YORK INC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FEXOFENODINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [PERRIGO NEW YORK INC]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	FEXOFENODINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FEXOFENODINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [PERRIGO NEW YORK INC]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	FEXOFENODINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [PERRIGO NEW YORK INC]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [PERRIGO NEW YORK INC]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	FEXOFENODINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [PERRIGO NEW YORK INC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	FEXOFENODINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [PERRIGO NEW YORK INC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FEXOFENODINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [PERRIGO NEW YORK INC]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	FEXOFENODINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [PERRIGO NEW YORK INC]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	FEXOFENODINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [PERRIGO NEW YORK INC]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FEXOFENODINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [PERRIGO NEW YORK INC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FEXOFENODINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
FEXOFENADINE HYDROCHLORIDE	ACTIVE INGREDIENT	2S068B75ZU	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
FEXOFENADINE HYDROCHLORIDE	ACTIVE INGREDIENT	2S068B75ZU	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
FEXOFENADINE HYDROCHLORIDE	ACTIVE INGREDIENT	2S068B75ZU	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
FEXOFENADINE	ACTIVE MOIETY	E6582LOH6V	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
FEXOFENADINE	ACTIVE MOIETY	E6582LOH6V	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
FEXOFENADINE	ACTIVE MOIETY	E6582LOH6V	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
997501	fexofenadine HCl 60 MG Oral Tablet	PSN	90e40219-28f1-4ea1-aa3a-ade4150cfadd	12
997501	fexofenadine hydrochloride 60 MG Oral Tablet	SCD	90e40219-28f1-4ea1-aa3a-ade4150cfadd	12
997501	fexofenadine HCl 60 MG Oral Tablet	PSN	0973dd39-0049-4db8-8d38-570fa38e1694	4
997501	fexofenadine hydrochloride 60 MG Oral Tablet	SCD	0973dd39-0049-4db8-8d38-570fa38e1694	4
997501	fexofenadine HCl 60 MG Oral Tablet	PSN	11926194-a656-2bfb-e054-00144ff88e88	1
997501	fexofenadine HCl 60 MG Oral Tablet	PSN	4a2530bc-176d-41c9-ab38-212165cbfa82	1
997501	fexofenadine HCl 60 MG Oral Tablet	PSN	b6a1df39-be21-48cb-b678-aeea00ee3763	1
997501	fexofenadine hydrochloride 60 MG Oral Tablet	SCD	11926194-a656-2bfb-e054-00144ff88e88	1
997501	fexofenadine hydrochloride 60 MG Oral Tablet	SCD	4a2530bc-176d-41c9-ab38-212165cbfa82	1
997501	fexofenadine hydrochloride 60 MG Oral Tablet	SCD	b6a1df39-be21-48cb-b678-aeea00ee3763	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45802-425-78	45802042578	1 BOTTLE in 1 CARTON (45802-425-78) > 100 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2011-08-08	2023-01-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Perrigo Fexofenadine Hydrochloride Tablets, 60 mg Drug Facts	Padagis Israel Pharmaceuticals Ltd	2022-09-01	HUMAN OTC DRUG LABEL	8
Perrigo Fexofenadine Hydrochloride Tablets, 60 mg Drug Facts	Bryant Ranch Prepack	2021-12-27	HUMAN OTC DRUG LABEL	4
Perrigo Fexofenadine Hydrochloride Tablets, 60 mg Drug Facts	A-S Medication Solutions	2021-06-15	HUMAN OTC DRUG LABEL	12
Perrigo Fexofenadine Hydrochloride Tablets, 60 mg Drug Facts	NuCare Pharmaceuticals, Inc.	2021-02-22	HUMAN OTC DRUG LABEL	5
Perrigo Fexofenadine Hydrochloride Tablets, 60 mg Drug Facts	RPK Pharmaceuticals, Inc.	2020-12-16	HUMAN OTC DRUG LABEL	3
Fexofenadine Hydrochloride Tablets, 60 mg Drug Facts	Denton Pharma, Inc. dba Northwind Pharmaceuticals	2020-02-26	HUMAN OTC DRUG LABEL	1
Perrigo Fexofenadine Hydrochloride Tablets, 60 mg Drug Facts	Proficient Rx LP	2019-11-01	HUMAN OTC DRUG LABEL	3
Perrigo Fexofenadine Hydrochloride Tablets, 60 mg Drug Facts	Carilion Materials Management	2017-07-06	HUMAN OTC DRUG LABEL	4
Perrigo Fexofenadine Hydrochloride Tablets, 60 mg Drug Facts	Blenheim Pharmacal, Inc.	2015-03-18	HUMAN OTC DRUG LABEL	1
Fexofenadine Hydrochloride Tablets	NCS HealthCare of KY, Inc dba Vangard Labs	2012-04-26	HUMAN OTC DRUG LABEL	2
Perrigo Fexofenadine Hydrochloride Tablets, 60 mg Drug Facts	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2012-02-03	HUMAN OTC DRUG LABEL	1
Perrigo Fexofenadine Hydrochloride Tablets, 60 mg Drug Facts	Rebel Distributors Corp	2012-01-17	HUMAN OTC DRUG LABEL	1