Fexofenadine HCL

Product NDC: 70677-1256
Requested package NDC: 70677-1256-1
11-digit product format: 706771256
Labeler code: 70677
Product ID: 70677-1256_31168932-2ebb-7423-e063-6394a90a081f
Type: HUMAN OTC DRUG
Nonproprietary name: Fexofenadine HCL
Dosage form: TABLET
Route: ORAL
Labeler: Strategic Sourcing Services
Application: ANDA204097
Marketing category: ANDA
Marketing start: 2025-05-01
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A204097-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2016-08-19
A204097-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2016-08-19
A204097-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2016-08-19

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 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204097-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2016-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204097-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2016-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204097-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2016-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204097-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2016-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204097-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2016-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204097-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2016-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204097-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2016-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204097-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2016-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204097-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2016-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204097-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2016-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204097-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2016-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204097-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2016-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204097-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2016-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204097-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2016-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204097-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2016-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204097-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2016-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204097-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2016-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204097-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2016-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204097-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2016-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204097-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2016-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204097-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2016-08-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204097-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2016-08-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204097-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2016-08-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204097-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2016-08-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204097-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2016-08-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204097-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2016-08-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204097-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2016-08-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204097-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2016-08-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204097-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2016-08-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204097-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2016-08-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204097-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2016-08-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204097-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2016-08-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204097-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2016-08-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204097-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2016-08-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204097-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2016-08-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204097-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2016-08-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204097-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2016-08-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204097-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2016-08-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204097-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2016-08-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204097-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2016-08-19	`8072bd15b7f6…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fexofenadine HCL	FEXOFENADINE HCL	Walmart Inc.	353323b7-67ce-7ce6-e063-6394a90a77d4	2026-07-21	Warnings	Exact identifier application applno (ANDA): 204097 application number: ANDA204097
equate allergy relief	FEXOFENADINE HYDROCHLORIDE	Walmart Inc.	852c8ad2-fc7d-4728-b2c6-f64b960fe2ab	2026-07-18	Warnings	Exact identifier application applno (ANDA): 204097 application number: ANDA204097
Goodmeds Non Drowsy Allergy Relief	FEXOFENADINE HYDROCHLORIDE	Cabinet Health P.B.C.	ae1322f5-85d6-4243-b384-2ce7f8c8d692	2026-04-20	Warnings	Exact identifier application applno (ANDA): 204097 application number: ANDA204097
Fexofenadine HCL	FEXOFENADINE HCL	Preferred Pharmaceuticals, Inc.	67679801-a8fe-4038-be71-96e1312badab	2026-04-16	Warnings	Exact identifier application applno (ANDA): 204097 application number: ANDA204097
ValuMeds Non-Drowsy Allergy Relief Fexofenadine HCl	FEXOFENADINE HYDROCHLORIDE	Cabinet Health P.B.C.	f9ccd673-c65f-45c6-9863-26136eb816db	2026-01-06	Warnings	Exact identifier application applno (ANDA): 204097 application number: ANDA204097
Fexofenadine HCL	FEXOFENADINE HCL	Northwind Health Company, LLC	f7584431-11aa-8213-e053-6294a90a1585	2026-01-01	Warnings	Exact identifier application applno (ANDA): 204097 application number: ANDA204097
Fexofenadine HCL	FEXOFENADINE HCL	YYBA Corp	52d50976-e63a-b3e3-e063-6294a90a6a97	2026-01-01	Warnings	Exact identifier application applno (ANDA): 204097 application number: ANDA204097
Fexofenadine HCL	FEXOFENADINE HCL	PD-Rx Pharmaceuticals, Inc.	07460764-43fa-49fd-ae77-d4571cb9f944	2025-10-08	Warnings	Exact identifier application applno (ANDA): 204097 application number: ANDA204097
24HR Allergy Relief	FEXOFENADINE HYDROCHLORIDE	CARDINAL HEALTH 110, LLC. DBA LEADER	b72c4802-1bcb-48bc-b4b9-72167ea4643e	2025-06-12	Warnings	Exact identifier application applno (ANDA): 204097 application number: ANDA204097
Fexofenadine HCL	FEXOFENADINE HCL	Strategic Sourcing Services	722eda62-9204-400a-8db4-e4aba9cd443b	2025-03-24	Warnings	Exact identifier application applno (ANDA): 204097 application number: ANDA204097 ndc (package): 70677-1256-1 ndc (product): 70677-1256 ndc11 (package): 70677125601
Fexofenadine HCL	FEXOFENADINE HCL	Bryant Ranch Prepack	6bc92969-0d06-4bf5-a634-80964464546c	2024-08-23	Warnings	Exact identifier application applno (ANDA): 204097 application number: ANDA204097
Allergy Relief	ALLERGY RELIEF	Allegiant Health	89ece1b5-7604-4dce-a8a6-df5b948e3cff	2024-04-17	Warnings	Exact identifier application applno (ANDA): 204097 application number: ANDA204097
Fexofenadine HCL	FEXOFENADINE HCL	Proficient Rx LP	f9a7e836-6055-484f-a197-181220428574	2024-03-01	Warnings	Exact identifier application applno (ANDA): 204097 application number: ANDA204097
Fexofenadine HCL	FEXOFENADINE HCL	A-S Medication Solutions	767b082e-915d-482f-8c6b-22b6e23bca19	2023-12-27	Warnings	Exact identifier application applno (ANDA): 204097 application number: ANDA204097
Fexofenadine HCL	FEXOFENADINE HCL	A-S Medication Solutions	b420b619-e643-43e6-9b8b-81af11fdd4ed	2023-12-15	Warnings	Exact identifier application applno (ANDA): 204097 application number: ANDA204097
Fexofenadine HCL	FEXOFENADINE HCL	A-S Medication Solutions	a96e6e63-3be9-4e89-ae45-b74b378997b1	2023-10-23	Warnings	Exact identifier application applno (ANDA): 204097 application number: ANDA204097
Childrens Allergy Relief	FEXOFENADINE HCL	PLD Acquisitions LLC DBA Avma Pharma Solutions	052d6191-1d9c-45c9-8c81-d19a977eded5	2023-02-13	Warnings	Exact identifier application applno (ANDA): 204097 application number: ANDA204097
Allergy Relief	FEXOFENADINE HCL	PLD Acquisitions LLC DBA Avma Pharma Solutions	0c83f650-f2bf-4c5b-a1e3-7c40cd9c4c6f	2023-02-09	Warnings	Exact identifier application applno (ANDA): 204097 application number: ANDA204097
Allergy Relief	FEXOFENADINE HCL	PLD Acquisitions LLC DBA Avma Pharma Solutions	9f1f292d-6d5f-4600-ad27-323e498ddecb	2023-02-09	Warnings	Exact identifier application applno (ANDA): 204097 application number: ANDA204097
Fexofenadine HCL	FEXOFENADINE HCL	NorthStar RxLLC	9c308a91-640d-441b-8fb5-acb5a415405e	2019-04-30	Warnings	Exact identifier application applno (ANDA): 204097 application number: ANDA204097

Additional Listing Data#

Finished product: Yes
Brand name base: Fexofenadine HCL
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
722eda62-9204-400a-8db4-e4aba9cd443b	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
70677-1256-1	Fexofenadine HCL	1 in 1 CARTON	TABLET	1	1
70677-1256-1	Fexofenadine HCL	30 in 1 BOTTLE	TABLET	30	1
70677-1256-2	Fexofenadine HCL	1 in 1 CARTON	TABLET	1	1
70677-1256-2	Fexofenadine HCL	500 in 1 BOTTLE	TABLET	500	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70677-1256-1	EA - Each	70677-1256	214cf67b-4aaa-48c1-887b-a3b50de12a87	1	2025-05-14
70677-1256-2	EA - Each	70677-1256	8722da54-5828-48f9-bf79-d14ca66854b8	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70677-1256	FEXOFENADINE HCL (FEXOFENADINE HCL) TABLET [STRATEGIC SOURCING SERVICES]	1	Current NDC, 4 package rows	20250501_722eda62-9204-400a-8db4-e4aba9cd443b.zip

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	722eda62-9204-400a-8db4-e4aba9cd443b	1
997420	fexofenadine hydrochloride 180 MG Oral Tablet	SCD	722eda62-9204-400a-8db4-e4aba9cd443b	1
997420	fexofenadine HCl 180 MG 24 HR Oral Tablet	SY	722eda62-9204-400a-8db4-e4aba9cd443b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70677-1256-1	70677125601	1 BOTTLE in 1 CARTON (70677-1256-1) / 30 TABLET in 1 BOTTLE	1 bottle	2025-05-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fexofenadine Hydrochloride Tablets USP, 180 mg	Strategic Sourcing Services \| Hetero Labs Limited Unit V	2025-03-24	HUMAN OTC DRUG LABEL	1