FEXOFENADINE HYDROCHLORIDE

Product NDC: 51316-800
11-digit product format: 513160800
Labeler code: 51316
Product ID: 51316-800_e6bae65e-9f41-4976-bebd-c14e86da14cb
Type: HUMAN OTC DRUG
Nonproprietary name: FEXOFENADINE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: CVS PHARMACY, INC
Application: ANDA091567
Marketing category: ANDA
Marketing start: 2022-09-20
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 42.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A091567-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2012-02-06
A091567-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2012-02-06
A091567-003	FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2012-02-06
A091567-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2012-02-06
A091567-005	FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2012-02-06
A091567-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2012-02-06

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 7 · 252 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	A091567-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091567-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091567-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091567-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091567-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2012-02-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091567-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2012-02-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091567-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091567-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091567-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091567-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091567-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2012-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091567-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2012-02-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091567-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091567-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091567-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091567-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091567-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2012-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091567-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2012-02-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091567-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091567-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091567-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091567-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091567-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2012-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091567-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2012-02-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091567-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091567-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091567-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091567-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091567-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2012-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091567-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2012-02-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091567-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091567-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091567-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091567-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091567-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2012-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091567-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2012-02-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091567-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091567-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091567-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091567-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-06	`03ed91905a0d…`

Additional Listing Data#

Finished product: Yes
Brand name base: FEXOFENADINE HYDROCHLORIDE
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
7bc13851-291a-4582-8261-13c5022fbdd1	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
51316-800-08	FEXOFENADINE HYDROCHLORIDE	180 in 1 BOTTLE	TABLET	180	4
51316-800-08	FEXOFENADINE HYDROCHLORIDE	1 in 1 CARTON	TABLET	1	4
51316-800-15	FEXOFENADINE HYDROCHLORIDE	1 in 1 CARTON	TABLET	1	4
51316-800-15	FEXOFENADINE HYDROCHLORIDE	15 in 1 BLISTER PACK	TABLET	15	4
51316-800-30	FEXOFENADINE HYDROCHLORIDE	30 in 1 BOTTLE	TABLET	30	4
51316-800-30	FEXOFENADINE HYDROCHLORIDE	1 in 1 CARTON	TABLET	1	4
51316-800-45	FEXOFENADINE HYDROCHLORIDE	45 in 1 BOTTLE	TABLET	45	4
51316-800-45	FEXOFENADINE HYDROCHLORIDE	1 in 1 CARTON	TABLET	1	4
51316-800-70	FEXOFENADINE HYDROCHLORIDE	70 in 1 BOTTLE	TABLET	70	4
51316-800-70	FEXOFENADINE HYDROCHLORIDE	1 in 1 CARTON	TABLET	1	4
51316-800-90	FEXOFENADINE HYDROCHLORIDE	90 in 1 BOTTLE	TABLET	90	4
51316-800-90	FEXOFENADINE HYDROCHLORIDE	1 in 1 CARTON	TABLET	1	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51316-800	FEXOFENADINE HYDROCHLORIDE TABLET [CVS PHARMACY, INC]	4	Current NDC, 12 package rows	20240530_7bc13851-291a-4582-8261-13c5022fbdd1.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	NCS HealthCare of KY, LLC dba Vangard Labs	58193632-2468-4159-b1a9-c24a489f199f	2026-06-24	Warnings	Exact identifier application applno (ANDA): 091567 application number: ANDA091567
FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	OHM LABORATORIES INC.	1a1afa95-570d-456e-b436-a0fcfaf68517	2026-05-05	Warnings	Exact identifier application applno (ANDA): 091567 application number: ANDA091567
FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	CVS PHARMACY, INC	7bc13851-291a-4582-8261-13c5022fbdd1	2024-05-24	Warnings	Exact identifier application applno (ANDA): 091567 application number: ANDA091567 ndc (product): 51316-800
FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	AMERISOURCE BERGEN	2a578643-adc1-44ca-83f2-9d48527bd3a4	2024-05-14	Warnings	Exact identifier application applno (ANDA): 091567 application number: ANDA091567

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	7bc13851-291a-4582-8261-13c5022fbdd1	4
997420	fexofenadine hydrochloride 180 MG Oral Tablet	SCD	7bc13851-291a-4582-8261-13c5022fbdd1	4
997420	fexofenadine HCl 180 MG 24 HR Oral Tablet	SY	7bc13851-291a-4582-8261-13c5022fbdd1	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
51316-800-08	51316080008	1 BOTTLE in 1 CARTON (51316-800-08) / 180 TABLET in 1 BOTTLE	1 bottle	2022-09-20	No	No	Current
51316-800-15	51316080015	1 BLISTER PACK in 1 CARTON (51316-800-15) / 15 TABLET in 1 BLISTER PACK	1 blister pack	2022-09-20	No	No	Current
51316-800-30	51316080030	1 BOTTLE in 1 CARTON (51316-800-30) / 30 TABLET in 1 BOTTLE	1 bottle	2022-09-20	No	No	Current
51316-800-45	51316080045	1 BOTTLE in 1 CARTON (51316-800-45) / 45 TABLET in 1 BOTTLE	1 bottle	2022-09-20	No	No	Current
51316-800-70	51316080070	1 BOTTLE in 1 CARTON (51316-800-70) / 70 TABLET in 1 BOTTLE	1 bottle	2022-09-20	No	No	Current
51316-800-90	51316080090	1 BOTTLE in 1 CARTON (51316-800-90) / 90 TABLET in 1 BOTTLE	1 bottle	2022-09-20	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fexofenadine Hydrochloride Tablets, USP 180 mg	CVS PHARMACY, INC \| Sun Pharmaceutical Industries Limited	2024-05-24	HUMAN OTC DRUG LABEL	4