FEXOFENADINE HYDROCHLORIDE

Product NDC: 51660-998
11-digit product format: 516600998
Labeler code: 51660
Product ID: 51660-998_5110b287-1464-50d9-e063-6394a90abe0f
Type: HUMAN OTC DRUG
Nonproprietary name: FEXOFENADINE HYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: OHM LABORATORIES INC.
Application: ANDA091567
Marketing category: ANDA
Marketing start: 2022-04-29
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 · 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 · 258 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	A091567-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091567-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091567-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091567-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091567-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2012-02-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091567-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2012-02-06	`84e616aacf4f…`
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…`

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: FEXOFENADINE HYDROCHLORIDE
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
1a1afa95-570d-456e-b436-a0fcfaf68517	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
51660-998-30	FEXOFENADINE HYDROCHLORIDE	1 in 1 CARTON	TABLET, FILM COATED	1	2
51660-998-30	FEXOFENADINE HYDROCHLORIDE	30 in 1 BOTTLE	TABLET, FILM COATED	30	2
51660-998-55	FEXOFENADINE HYDROCHLORIDE	1 in 1 CARTON	TABLET, FILM COATED	1	2
51660-998-55	FEXOFENADINE HYDROCHLORIDE	150 in 1 BOTTLE	TABLET, FILM COATED	150	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51660-998-30	EA - Each	51660-998	148fc51a-2846-4d3f-86d5-0c73ea324946	1	2022-07-06
51660-998-55	EA - Each	51660-998	11233a29-7bc3-43ae-bb1e-0fa9185bc1df	1	2025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51660-998	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [OHM LABORATORIES INC.]	1	Current NDC, Legacy NDC, 4 package rows	20220503_1a1afa95-570d-456e-b436-a0fcfaf68517.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 ndc (product): 51660-998
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
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	1a1afa95-570d-456e-b436-a0fcfaf68517	2
997420	fexofenadine hydrochloride 180 MG Oral Tablet	SCD	1a1afa95-570d-456e-b436-a0fcfaf68517	2
997420	fexofenadine HCl 180 MG 24 HR Oral Tablet	SY	1a1afa95-570d-456e-b436-a0fcfaf68517	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51660-998-30	51660099830	1 BOTTLE in 1 CARTON (51660-998-30) / 30 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2022-04-29	0000-00-00	No	No	Current
51660-998-55	51660099855	1 BOTTLE in 1 CARTON (51660-998-55) / 150 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2022-04-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fexofenadine Hydrochloride Tablets, USP 180 mg	NCS HealthCare of KY, LLC dba Vangard Labs	2026-06-24	HUMAN OTC DRUG LABEL	1
Fexofenadine Hydrochloride Tablets, USP 180 mg	OHM LABORATORIES INC. \| Sun Pharmaceutical Industries Limited	2026-05-05	HUMAN OTC DRUG LABEL	2