topcare childrens allergy relief

Product NDC: 36800-363
11-digit product format: 368000363
Labeler code: 36800
Product ID: 36800-363_d6a8c36e-4c50-4c16-96a0-2b056a050e17
Type: HUMAN OTC DRUG
Nonproprietary name: loratadine
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Topco Associates LLC
Application: ANDA210033
Marketing category: ANDA
Marketing start: 2019-09-20
Substance: LORATADINE
Active strength: 5 mg/1
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210033-001	LORATADINE	LORATADINE	5MG	TABLET, CHEWABLE / ORAL			2019-06-12

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 · 41 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	A210033-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2019-06-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210033-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2019-06-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210033-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2019-06-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210033-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2019-06-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210033-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2019-06-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210033-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2019-06-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210033-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2019-06-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210033-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2019-06-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210033-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2019-06-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210033-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2019-06-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210033-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2019-06-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210033-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2019-06-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210033-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2019-06-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210033-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2019-06-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210033-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2019-06-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210033-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2019-06-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210033-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2019-06-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210033-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2019-06-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210033-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2019-06-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210033-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2019-06-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210033-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2019-06-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210033-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2019-06-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210033-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2019-06-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210033-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2019-06-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210033-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2019-06-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210033-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2019-06-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210033-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2019-06-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210033-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2019-06-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210033-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2019-06-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210033-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2019-06-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210033-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2019-06-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210033-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2019-06-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210033-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2019-06-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210033-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2019-06-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210033-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2019-06-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210033-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2019-06-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210033-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2019-06-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210033-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2019-06-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210033-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2019-06-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210033-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2019-06-12	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: topcare childrens allergy relief
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LORATADINE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7AJO3BO7QN	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
665078	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
4f7555ea-6286-4ff6-b125-d12660ae4bdf	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
36800-363-39	topcare childrens allergy relief	1 in 1 BLISTER PACK	TABLET, CHEWABLE	1	4
36800-363-39	topcare childrens allergy relief	30 in 1 CARTON	TABLET, CHEWABLE	30	4
36800-363-49	topcare childrens allergy relief	1 in 1 BLISTER PACK	TABLET, CHEWABLE	1	4
36800-363-49	topcare childrens allergy relief	40 in 1 CARTON	TABLET, CHEWABLE	40	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-363	TOPCARE CHILDRENS ALLERGY RELIEF (LORATADINE) TABLET, CHEWABLE [TOPCO ASSOCIATES LLC]	4	Current NDC, Legacy NDC, 4 package rows	20230625_4f7555ea-6286-4ff6-b125-d12660ae4bdf.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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Berkley and Jensen Childrens Allergy Relief	LORATADINE	BJWC	7f9b6a94-2be4-4c96-9a7d-8443f911a4cc	2026-05-21	Warnings	Exact identifier application applno (ANDA): 210033 application number: ANDA210033
good sense childrens allergy relief	LORATADINE	L. Perrigo Company	643dfe16-9cd1-47bb-8bce-303e6885c644	2026-04-20	Warnings	Exact identifier application applno (ANDA): 210033 application number: ANDA210033
Claritin	LORATADINE	Bayer HealthCare LLC.	f3b9c643-a605-7702-e053-2995a90a6130	2025-12-04	Warnings	Exact identifier application applno (ANDA): 210033 application number: ANDA210033
childrens allergy relief	LORATADINE	Meijer Distribution Inc	b27f0bd0-4e61-4498-b5b7-54ae31f637f3	2025-05-07	Warnings	Exact identifier application applno (ANDA): 210033 application number: ANDA210033
childrens allergy relief	LORATADINE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	bc789b82-56ca-4248-b60a-252d9695636a	2024-06-12	Warnings	Exact identifier application applno (ANDA): 210033 application number: ANDA210033
foster and thrive childrens allergy relief	LORATADINE	Strategic Sourcing Services LLC	5ac59de8-46ad-4731-8f98-167fb5f8b089	2023-10-30	Warnings	Exact identifier application applno (ANDA): 210033 application number: ANDA210033
Equaline Childrens Allergy Relief	LORATADINE	United Natural Foods, Inc. dba UNFI	25329c7d-76e7-47b3-914e-ac367bbb750b	2023-08-17	Warnings	Exact identifier application applno (ANDA): 210033 application number: ANDA210033
topcare childrens allergy relief	LORATADINE	Topco Associates LLC	4f7555ea-6286-4ff6-b125-d12660ae4bdf	2023-06-20	Warnings	Exact identifier application applno (ANDA): 210033 application number: ANDA210033 ndc (product): 36800-363
childrens allergy relief	LORATADINE	Rite Aid Corporation	f8ddeb7e-94b1-4dce-815f-b6b8c71e88fd	2023-04-13	Warnings	Exact identifier application applno (ANDA): 210033 application number: ANDA210033
Childrens Allergy Relief	LORATADINE	H E B	704ee04d-6bdd-4d0a-ba24-2a9fd79a90fb	2021-08-24	Warnings	Exact identifier application applno (ANDA): 210033 application number: ANDA210033
Basic Care Childrens Allergy Relief	LORATADINE	Amazon.com Services LLC	e2c83874-aa95-477a-9cfd-cecfd776ba0e	2021-08-12	Warnings	Exact identifier application applno (ANDA): 210033 application number: ANDA210033
careone childrens allergy relief	LORATADINE	American Sales Company	06d1c443-ec23-4aa1-a7f3-f2b7ffcc2588	2020-08-10	Warnings	Exact identifier application applno (ANDA): 210033 application number: ANDA210033
dg health childrens allergy relief	LORATADINE	Dolgencorp, LLC	302fc570-bec9-43cb-8965-139576102cdd	2020-06-10	Warnings	Exact identifier application applno (ANDA): 210033 application number: ANDA210033

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7AJO3BO7QN	LORATADINE	79794-75-5	LORATADINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
665078	loratadine 5 MG 24HR Chewable Tablet	PSN	4f7555ea-6286-4ff6-b125-d12660ae4bdf	4
665078	loratadine 5 MG Chewable Tablet	SCD	4f7555ea-6286-4ff6-b125-d12660ae4bdf	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-363-39	36800036339	30 BLISTER PACK in 1 CARTON (36800-363-39) / 1 TABLET, CHEWABLE in 1 BLISTER PACK	30 blister pack	2019-09-20	0000-00-00	No	No	Current
36800-363-49	36800036349	40 BLISTER PACK in 1 CARTON (36800-363-49) / 1 TABLET, CHEWABLE in 1 BLISTER PACK	40 blister pack	2023-06-20		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topco Associates LLC. Children’s Allergy Relief Drug Facts	Topco Associates LLC	2023-06-20	HUMAN OTC DRUG LABEL	4