Allergy Relief

Product NDC: 81522-613
11-digit product format: 815220613
Labeler code: 81522
Product ID: 81522-613_e33cf239-32e7-40e0-bf95-183d6cee81a1
Type: HUMAN OTC DRUG
Nonproprietary name: Fexofenadine HCl
Dosage form: TABLET, COATED
Route: ORAL
Labeler: FSA Store Inc. (Caring Mills)
Application: ANDA211075
Marketing category: ANDA
Marketing start: 2021-10-08
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2019-12-13 00:20 UTC	2019-12	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Allergy Relief
Listing expiration: 2027-12-31

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
d33f15db-0e5e-4515-b7a7-cb2760469ac1	Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
81522-613-30	Allergy Relief	1 in 1 BOX	TABLET, COATED	1		3
81522-613-30	Allergy Relief	30 in 1 BOTTLE, PLASTIC	TABLET, COATED	30		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81522-613	ALLERGY RELIEF (FEXOFENADINE HCL) TABLET, COATED [FSA STORE INC. (CARING MILLS)]	3	Current NDC, Legacy NDC, 2 package rows	20240125_d33f15db-0e5e-4515-b7a7-cb2760469ac1.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 3 of 3 · 58 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
allergy relief	FEXOFENADINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	ccff9b0f-8ae5-057f-e053-2a95a90ac2b1	2023-05-17	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Crcle Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Innovus Pharmaceuticals, Inc.	f7784610-7ca5-4489-b391-f2b3f3f6549b	2023-04-08	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Safrel Pharmaceuticals, LLC.	d6120f56-ab28-2696-e053-2995a90adf47	2023-03-28	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Allergy Relief	FEXOFENADINE HCL	CVS PHARMACY, INC	57be0a69-9c5e-41a1-abd3-0b0e8a81093a	2023-02-16	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	HARRIS TEETER	e5429440-fc89-4200-e053-2995a90afc7d	2022-11-23	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	MARC GLASSMAN, INC.	c4f93336-cfd8-e023-e053-2995a90a9df0	2022-10-06	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	HEB	7cb25829-3aee-4a82-869d-ab4259626584	2022-05-31	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	HEB	d8b852a1-7315-4047-aed6-cd40c7a39e70	2022-05-31	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Allergy Relief	FEXOFENADINE HCL	Best Choice (Valu Merchandisers Company)	c3c56f76-636c-45fa-8c1a-63da7b491bc5	2022-05-19	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Allergy Relief Non Drowsy	FEXOFENADINE HCL	Allegiant Health	219606a8-9a3e-4c30-adb1-984f3f4e72c7	2022-05-19	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Allergy Relief Non Drowsy	FEXOFENADINE HCL	WinCo Foods	4b1fa4dd-885e-4873-a98f-3656dad0594c	2022-01-06	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	DISCOUNT DRUG MART	c5106c63-af53-c169-e053-2a95a90afef2	2021-11-30	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
ALLERGY RELIEF	FEXOFENADINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC.	c1be67ea-9973-49e2-e053-2995a90a423c	2021-10-24	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
12HR Allergy Relief	FEXOFENADINE HYDROCHLORIDE	CARDINAL HEALTH	ea5d0e55-2191-4094-b082-24b317f95752	2021-09-24	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Allergy Relief	FEXOFENADINE HCL	Allegiant Health	25e72bd3-25c6-4943-92bb-27f9543e2d8a	2021-03-23	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

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	d33f15db-0e5e-4515-b7a7-cb2760469ac1	3
997420	fexofenadine hydrochloride 180 MG Oral Tablet	SCD	d33f15db-0e5e-4515-b7a7-cb2760469ac1	3
997420	fexofenadine HCl 180 MG 24 HR Oral Tablet	SY	d33f15db-0e5e-4515-b7a7-cb2760469ac1	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
81522-613-30	81522061330	1 BOTTLE, PLASTIC in 1 BOX (81522-613-30) / 30 TABLET, COATED in 1 BOTTLE, PLASTIC	2021-10-08	0000-00-00	No	No	Current