Childrens Allergy

Product NDC: 63941-923
Requested package NDC: 63941-923-04
11-digit product format: 639410923
Labeler code: 63941
Product ID: 63941-923_9b823fef-4aa0-413c-9306-aff6038788e9
Type: HUMAN OTC DRUG
Nonproprietary name: Fexofenadine HCL
Dosage form: SUSPENSION
Route: ORAL
Labeler: Best Choice (Valu Merchandisers Company)
Application: ANDA203330
Marketing category: ANDA
Marketing start: 2022-10-07
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63941-923	63941-923-04	D	Discontinued by firm		2026-10-05

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
A203330-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL			2014-11-18
A203330-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL		RS	2014-11-18

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A203330-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL		2014-11-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203330-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	RS	2014-11-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203330-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL		2014-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203330-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	RS	2014-11-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203330-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL		2014-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203330-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	RS	2014-11-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203330-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL		2014-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203330-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	RS	2014-11-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203330-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL		2014-11-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203330-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	RS	2014-11-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203330-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL		2014-11-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203330-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	RS	2014-11-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203330-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL		2014-11-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203330-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	RS	2014-11-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203330-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL		2014-11-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203330-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	RS	2014-11-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203330-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL		2014-11-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203330-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	RS	2014-11-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203330-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL		2014-11-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203330-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	RS	2014-11-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203330-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL		2014-11-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203330-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	RS	2014-11-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203330-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL		2014-11-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203330-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	RS	2014-11-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203330-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL		2014-11-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203330-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	RS	2014-11-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203330-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL		2014-11-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203330-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	RS	2014-11-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203330-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL		2014-11-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203330-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	RS	2014-11-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203330-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL		2014-11-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203330-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	RS	2014-11-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203330-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL		2014-11-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203330-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	RS	2014-11-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203330-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL		2014-11-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203330-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	RS	2014-11-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203330-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL		2014-11-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203330-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	RS	2014-11-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203330-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL		2014-11-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203330-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	RS	2014-11-18	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63941-923	CHILDRENS ALLERGY (FEXOFENADINE HCL) SUSPENSION [BEST CHOICE (VALU MERCHANDISERS COMPANY)]	2	Legacy NDC	20241004_67c6b0d3-b168-46da-a2de-adfcc4804222.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Allergy	FEXOFENADINE HCL	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	667c87c2-c594-49e5-92a7-f8aa140642d6	2026-08-12	Warnings	Exact identifier application applno (ANDA): 203330 application number: ANDA203330
Childrens Allergy	FEXOFENADINE HYDROCHLORIDE	H2-Pharma, LLC	84988f6d-85b1-45dd-89be-0333acc6b180	2026-06-25	Warnings	Exact identifier application applno (ANDA): 203330 application number: ANDA203330
Children Allergy	FEXOFENADINE HCL	H E B	a26c3515-4a24-4988-b9bb-813420b15630	2026-05-12	Warnings	Exact identifier application applno (ANDA): 203330 application number: ANDA203330
Childrens Allergy	FEXOFENADINE HCL	CVS PHARMACY, INC	4ab89e0a-d5aa-481b-8793-c940a27ebeb2	2026-05-11	Warnings	Exact identifier application applno (ANDA): 203330 application number: ANDA203330
Childrens Allergy	FEXOFENADINE HCL	Family Dollar (FAMILY WELLNESS)	f7114f9d-5708-497a-8390-a11a82c8d84f	2026-05-06	Warnings	Exact identifier application applno (ANDA): 203330 application number: ANDA203330
Childrens Allergy	FEXOFENADINE HCL	H E B	3b6f4a4b-b1bd-4062-9e7f-571b836b1536	2026-05-06	Warnings	Exact identifier application applno (ANDA): 203330 application number: ANDA203330
Dye Free Wal Fex childrens allergy	FEXOFENADINE HCL	Walgreens	9062c258-4c3e-412d-a31f-1e748a67513f	2025-09-02	Warnings	Exact identifier application applno (ANDA): 203330 application number: ANDA203330
Children Allergy	FEXOFENADINE HCL	Walgreens	30517ea8-0a97-4c8f-ad95-739a103784c5	2025-09-02	Warnings	Exact identifier application applno (ANDA): 203330 application number: ANDA203330
Childrens Allergy	FEXOFENADINE HCL	WALMART INC. (see also Equate)	fb163eea-b2d2-4f52-9123-0bbe28baf757	2024-03-22	Warnings	Exact identifier application applno (ANDA): 203330 application number: ANDA203330

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2S068B75ZU	FEXOFENADINE HYDROCHLORIDE	153439-40-8	FEXOFENADINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63941-923-04	63941092304	1 BOTTLE, PLASTIC in 1 BOX (63941-923-04) > 118 mL in 1 BOTTLE, PLASTIC	2022-10-07	0000-00-00	No	No	Current