CareOne Allergy Relief

Product NDC: 41520-229
11-digit product format: 415200229
Labeler code: 41520
Product ID: 41520-229_57501f04-ba3d-4e21-af64-60674a4c9256
Type: HUMAN OTC DRUG
Nonproprietary name: fexofenadine hcl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: American Sales Company
Application: ANDA076447
Marketing category: ANDA
Marketing start: 2016-10-14
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: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: CareOne Allergy Relief
Listing expiration: 2026-12-31

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
65720e72-c20d-4363-92ab-76596e043bc0	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	SPL version
41520-229-22	CareOne Allergy Relief	15 in 1 CARTON	TABLET, FILM COATED	15	5
41520-229-22	CareOne Allergy Relief	1 in 1 BLISTER PACK	TABLET, FILM COATED	1	5
41520-229-39	CareOne Allergy Relief	30 in 1 BOTTLE	TABLET, FILM COATED	30	5
41520-229-39	CareOne Allergy Relief	1 in 1 CARTON	TABLET, FILM COATED	1	5
41520-229-95	CareOne Allergy Relief	1 in 1 CARTON	TABLET, FILM COATED	1	5
41520-229-95	CareOne Allergy Relief	45 in 1 BOTTLE	TABLET, FILM COATED	45	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41520-229	CAREONE ALLERGY RELIEF (FEXOFENADINE HCL) TABLET, FILM COATED [AMERICAN SALES COMPANY]	5	Current NDC, Legacy NDC, 6 package rows	20210724_65720e72-c20d-4363-92ab-76596e043bc0.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 ndc (product): 41520-229

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	65720e72-c20d-4363-92ab-76596e043bc0	5
997420	fexofenadine hydrochloride 180 MG Oral Tablet	SCD	65720e72-c20d-4363-92ab-76596e043bc0	5
997420	fexofenadine HCl 180 MG 24 HR Oral Tablet	SY	65720e72-c20d-4363-92ab-76596e043bc0	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41520-229-22	41520022922	15 BLISTER PACK in 1 CARTON (41520-229-22) / 1 TABLET, FILM COATED in 1 BLISTER PACK	15 blister pack	2016-10-14	0000-00-00	No	No	Current
41520-229-39	41520022939	1 BOTTLE in 1 CARTON (41520-229-39) / 30 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2016-10-14	0000-00-00	No	No	Current
41520-229-95	41520022995	1 BOTTLE in 1 CARTON (41520-229-95) / 45 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2016-10-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
American Sales Company Allergy Relief Drug Facts	American Sales Company	2021-07-12	HUMAN OTC DRUG LABEL	5