Fexofenadine HCl Tablets, 180 mg ANTIHISTAMINE

Manufacturer: Strategic Sourcing Services, LLC
Effective date: 2026-01-29
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 01:35:31

Label at a glance#

ProductFEXOFENADINE HCl

Active ingredientFEXOFENADINE HYDROCHLORIDE

Label structure1 sections

Label contents#

Full prescribing information#

Package and principle display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 1Label 2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
997420	fexofenadine HCl 180 MG 24 HR Oral Tablet	PSN	4
997420	fexofenadine hydrochloride 180 MG Oral Tablet	SCD	4
997420	fexofenadine HCl 180 MG 24 HR Oral Tablet	SY	4

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
FEXOFENADINE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

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
70677-1239-1	FEXOFENADINE HCl	100 in 1 BOTTLE	TABLET, FILM COATED	100		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70677-1239-1	EA - Each	70677-1239	a40a68d0-3e4d-4867-a486-e1b885df1829	1	2024-05-16

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

FEXOFENADINE HCl
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSE, UNSPECIFIED
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE
STARCH, CORN
WATER
TITANIUM DIOXIDE
FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70677-1239	70677-1239-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
POVIDONE	FZ989GH94E	IACT
STARCH, CORN	O8232NY3SJ	IACT
WATER	059QF0KO0R	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
FEXOFENADINE HYDROCHLORIDE	2S068B75ZU	ACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL			2018-08-13

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 2 · 43 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	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`f41ea6bd6efb…`

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
FEXOFENADINE HCl	FEXOFENADINE HCL	Strategic Sourcing Services, LLC	7a49f700-5892-404b-b81a-4a92c1928806	2026-01-29	Warnings	Exact identifier ndc (package): 70677-1239-1 ndc (product): 70677-1239 ndc11 (package): 70677123901 spl id: 498a79fc-c2a8-c5ea-e063-6294a90ab355 spl set id: 7a49f700-5892-404b-b81a-4a92c1928806

Reported adverse events (FAERS/openFDA)#

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