Childrens Allergy

Product NDC: 61269-527
11-digit product format: 612690527
Labeler code: 61269
Product ID: 61269-527_33920aab-2fdc-44ed-b36d-0d759a9bcd94
Type: HUMAN OTC DRUG
Nonproprietary name: fexofenadine hydrochloride
Dosage form: SUSPENSION
Route: ORAL
Labeler: H2-Pharma, LLC
Application: ANDA203330
Marketing category: ANDA
Marketing start: 2022-07-18
Marketing end: 2027-06-30
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

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	61269-527	61269-527-98	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61269-527	61269-527-98	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61269-527	61269-527-98	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 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…`
2022-03-09 01:35 UTC	2022-03	A203330-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL		2014-11-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203330-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	RS	2014-11-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203330-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	SUSPENSION / ORAL		2014-11-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203330-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	SUSPENSION / ORAL	RS	2014-11-18	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Childrens Allergy

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
84988f6d-85b1-45dd-89be-0333acc6b180	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
61269-527-94	Childrens Allergy	1 in 1 CARTON	SUSPENSION	1	3
61269-527-94	Childrens Allergy	118 mL in 1 BOTTLE	SUSPENSION	118	3
61269-527-98	Childrens Allergy	237 mL in 1 BOTTLE	SUSPENSION	237	3
61269-527-98	Childrens Allergy	1 in 1 CARTON	SUSPENSION	1	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61269-527-94	ML - Milliliter	61269-527	a2d29eb1-9492-44c9-b219-aae861938625	1	2022-08-04
61269-527-98	ML - Milliliter	61269-527	ff459bbc-d620-437e-997e-8337e0120ad8	1	2022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61269-527	CHILDRENS ALLERGY (FEXOFENADINE HYDROCHLORIDE) SUSPENSION [H2-PHARMA, LLC]	2	Current NDC, Legacy NDC, 4 package rows	20250413_84988f6d-85b1-45dd-89be-0333acc6b180.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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 ndc (product): 61269-527
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	Family Dollar (FAMILY WELLNESS)	ba4df76e-cbed-4e19-afc6-c76000f0bf4f	2024-06-04	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
Childrens Allergy	FEXOFENADINE HCL	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	667c87c2-c594-49e5-92a7-f8aa140642d6	2023-10-11	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

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	84988f6d-85b1-45dd-89be-0333acc6b180	3
997491	fexofenadine hydrochloride 6 MG/ML Oral Suspension	SCD	84988f6d-85b1-45dd-89be-0333acc6b180	3
997491	fexofenadine HCl 30 MG per 5 ML Oral Suspension	SY	84988f6d-85b1-45dd-89be-0333acc6b180	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61269-527-94	61269052794	1 BOTTLE in 1 CARTON (61269-527-94) / 118 mL in 1 BOTTLE	1 bottle	2022-07-18	0000-00-00	No	No	Current
61269-527-98	61269052798	1 BOTTLE in 1 CARTON (61269-527-98) > 237 mL in 1 BOTTLE	1 bottle	2022-07-18	0000-00-00	No	No	Current