Childrens Fexofenadine Hydrochloride

Product NDC: 0363-2141
Requested package NDC: 0363-2141-08
11-digit product format: 003632141
Labeler code: 0363
Product ID: 0363-2141_374f99cb-1562-7532-e063-6394a90a95b4
Type: HUMAN OTC DRUG
Nonproprietary name: Fexofenadine Hydrochloride
Dosage form: SUSPENSION
Route: ORAL
Labeler: Walgreens Company
Application: ANDA208123
Marketing category: ANDA
Marketing start: 2024-12-06
Substance: FEXOFENADINE HYDROCHLORIDE
Active strength: 30 mg/5mL
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 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A208123-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL			2017-11-09
A208123-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL			2017-11-09

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 3 · 86 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	A208123-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL	2017-11-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208123-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	2017-11-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208123-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL	2017-11-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208123-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	2017-11-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208123-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL	2017-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208123-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	2017-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208123-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL	2017-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208123-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	2017-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208123-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL	2017-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208123-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	2017-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208123-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL	2017-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208123-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	2017-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208123-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL	2017-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208123-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	2017-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208123-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL	2017-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208123-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	2017-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208123-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL	2017-11-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208123-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	2017-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208123-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL	2017-11-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208123-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	2017-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208123-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL	2017-11-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208123-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	2017-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208123-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL	2017-11-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208123-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	2017-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208123-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL	2017-11-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208123-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	2017-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208123-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL	2017-11-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208123-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	2017-11-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208123-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL	2017-11-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208123-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	2017-11-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208123-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL	2017-11-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208123-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	2017-11-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208123-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL	2017-11-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208123-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	2017-11-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208123-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL	2017-11-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208123-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	2017-11-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208123-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL	2017-11-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208123-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	2017-11-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208123-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL	2017-11-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208123-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	2017-11-09	`74a2ff9319b5…`

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: Childrens Fexofenadine Hydrochloride
Brand name suffix: Allergy
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FEXOFENADINE HYDROCHLORIDE	30 mg/5mL

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
997491	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
374f9271-b65b-69a9-e063-6394a90af36a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
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
0363-2141-01	Childrens Fexofenadine HydrochlorideAllergy	240 mL in 1 BOTTLE	SUSPENSION	240	1
0363-2141-01	Childrens Fexofenadine HydrochlorideAllergy	1 in 1 CARTON	SUSPENSION	1	1
0363-2141-08	Childrens Fexofenadine HydrochlorideAllergy	120 mL in 1 BOTTLE	SUSPENSION	120	1
0363-2141-08	Childrens Fexofenadine HydrochlorideAllergy	1 in 1 CARTON	SUSPENSION	1	1

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Fexofenadine Hydrochloride Allergy	FEXOFENADINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	b21bb11d-bf74-4ee7-9cfe-5b599a3c4775	2026-08-11	Warnings	Exact identifier application applno (ANDA): 208123 application number: ANDA208123
Childrens Fexofenadine Hydrochloride Allergy	FEXOFENADINE HYDROCHLORIDE	Walgreens Company	374f9271-b65b-69a9-e063-6394a90af36a	2025-06-11	Warnings	Exact identifier application applno (ANDA): 208123 application number: ANDA208123 ndc (package): 0363-2141-08 ndc (product): 0363-2141 ndc11 (package): 00363214108
Childrens Fexofenadine Hydrochloride Allergy	FEXOFENADINE HYDROCHLORIDE	Wal-Mart Stores Inc	2432f862-6d7e-666d-e063-6294a90acf74	2024-12-06	Warnings	Exact identifier application applno (ANDA): 208123 application number: ANDA208123

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
997491	fexofenadine HCl 30 MG in 5 mL Oral Suspension	PSN	374f9271-b65b-69a9-e063-6394a90af36a	1
997491	fexofenadine hydrochloride 6 MG/ML Oral Suspension	SCD	374f9271-b65b-69a9-e063-6394a90af36a	1
997491	fexofenadine HCl 30 MG per 5 ML Oral Suspension	SY	374f9271-b65b-69a9-e063-6394a90af36a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0363-2141-08	00363214108	1 BOTTLE in 1 CARTON (0363-2141-08) / 120 mL in 1 BOTTLE	1 bottle	2024-12-06	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Children's Fexofenadine HCl Allergy	Walgreens Company \| Taro Pharmaceutical Industries Ltd.	2025-06-11	HUMAN OTC DRUG LABEL	1