Fexofenadine hydrochloride

Product NDC: 13107-066
11-digit product format: 131070066
Labeler code: 13107
Product ID: 13107-066_536dab2f-7586-4d45-b745-99c6cab47743
Type: HUMAN OTC DRUG
Nonproprietary name: Fexofenadine hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aurolife Pharma, LLC
Application: ANDA202039
Marketing category: ANDA
Marketing start: 2015-08-26
Marketing end: 0000-00-00
Substance: FEXOFENADINE HYDROCHLORIDE
Active strength: 60 mg/1
NDC exclude flag: E
Listing certified through: 2018-12-31
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	13107-066		D	Discontinued by firm		2026-08-17
excluded package	package	13107-066	13107-066-05	D	Discontinued by firm		2026-08-17

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13107-066-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	13107-066-05	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	13107-066-05	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	13107-066-05	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	13107-066-05	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	13107-066-05	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	13107-066-05	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	13107-066-05	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	13107-066-05	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	13107-066-05	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	13107-066-05	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	13107-066-05	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	13107-066-05	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	13107-066-05	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	13107-066-05	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	13107-066-05	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	13107-066-05	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	13107-066-05	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	13107-066-05	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	13107-066-05	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	13107-066-05	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	13107-066-05	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A202039-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2014-11-19
A202039-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2014-11-19
A202039-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2014-11-19

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 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A202039-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2014-11-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202039-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2014-11-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202039-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2014-11-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202039-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2014-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202039-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2014-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202039-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2014-11-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202039-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2014-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202039-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2014-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202039-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2014-11-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202039-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2014-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202039-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2014-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202039-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2014-11-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202039-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2014-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202039-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2014-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202039-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2014-11-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202039-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2014-11-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202039-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2014-11-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202039-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2014-11-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202039-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2014-11-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202039-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2014-11-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202039-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2014-11-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202039-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2014-11-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202039-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2014-11-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202039-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2014-11-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202039-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2014-11-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202039-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2014-11-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202039-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2014-11-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202039-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2014-11-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202039-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2014-11-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202039-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2014-11-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202039-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2014-11-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202039-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2014-11-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202039-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2014-11-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202039-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2014-11-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202039-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2014-11-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202039-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2014-11-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202039-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2014-11-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202039-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2014-11-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202039-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2014-11-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202039-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2014-11-19	`1e350fbaab3a…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
13107-066-05	2025-12-19	C162847	48780-1	9d75b9d0-fd9f-f424-e053-dadaa90a57ce	bc176016-ebab-4430-82ac-dde96b545194
13107-066-05	2020-01-31	C162847	48780-1	9d75b9d0-fd9f-f424-e053-dadaa90a57ce	bc176016-ebab-4430-82ac-dde96b545194

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13107-066-05	EA - Each	13107-066	f90bcd92-7c7a-4425-9cf9-d59bec5aeb05	1	2015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FEXOFENADINE HYDROCHLORIDE	ACTIVE INGREDIENT	2S068B75ZU	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AVKARE, INC.]	2
FEXOFENADINE HYDROCHLORIDE	ACTIVE INGREDIENT	2S068B75ZU	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROLIFE PHARMA, LLC]	2
FEXOFENADINE	ACTIVE MOIETY	E6582LOH6V	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROLIFE PHARMA, LLC]	2
FEXOFENADINE	ACTIVE MOIETY	E6582LOH6V	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AVKARE, INC.]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AVKARE, INC.]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROLIFE PHARMA, LLC]	2
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AVKARE, INC.]	2
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROLIFE PHARMA, LLC]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AVKARE, INC.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROLIFE PHARMA, LLC]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROLIFE PHARMA, LLC]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AVKARE, INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AVKARE, INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROLIFE PHARMA, LLC]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AVKARE, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROLIFE PHARMA, LLC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AVKARE, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROLIFE PHARMA, LLC]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AVKARE, INC.]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROLIFE PHARMA, LLC]	2
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AVKARE, INC.]	2
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROLIFE PHARMA, LLC]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AVKARE, INC.]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROLIFE PHARMA, LLC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROLIFE PHARMA, LLC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AVKARE, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13107-066	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROLIFE PHARMA, LLC]	2	Legacy NDC	20150829_bc176016-ebab-4430-82ac-dde96b545194.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Aurohealth LLC	5413d84e-f945-4920-8981-f62978f21d67	2026-08-06	Warnings	Exact identifier application applno (ANDA): 202039 application number: ANDA202039
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Aurohealth LLC	683cb2ea-c913-48f4-8adc-2888da3b655e	2026-08-06	Warnings	Exact identifier application applno (ANDA): 202039 application number: ANDA202039
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Aurohealth LLC	eb8e67dc-e2df-4c35-bfd7-12af67e1354a	2026-08-06	Warnings	Exact identifier application applno (ANDA): 202039 application number: ANDA202039
Fexofenadine hydrochloride	FEXOFENADINE HYDROCHLORIDE	7-eleven	d5914c05-e8db-4c79-82d0-a279d1304118	2019-06-20	Warnings	Exact identifier application applno (ANDA): 202039 application number: ANDA202039

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fexofenadine Hydrochloride Tablets USP	AvKARE	2020-06-15	HUMAN OTC DRUG LABEL	5
Fexofenadine hydrochloride - Aurolife Pharma, LLC	Aurolife Pharma, LLC	2015-08-26	Human OTC Drug Label	2