basic care childrens allergy relief

Product NDC: 0113-7500
11-digit product format: 001137500
Labeler code: 0113
Product ID: 0113-7500_06b938da-0985-4368-8bbb-c953543166ef
Type: HUMAN OTC DRUG
Nonproprietary name: loratadine
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: L. Perrigo Company
Application: ANDA210033
Marketing category: ANDA
Marketing start: 2019-07-31
Marketing end: 2023-02-28
Substance: LORATADINE
Active strength: 5 mg/1
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0113-7500		D	Discontinued by firm	2026-08-17
excluded package	package	0113-7500	0113-7500-01	D	Discontinued by firm	2026-08-17
excluded package	package	0113-7500	0113-7500-49	D	Discontinued by firm	2026-08-17

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0113-7500-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0113-7500-49	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0113-7500-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0113-7500-49	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0113-7500-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0113-7500-49	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0113-7500-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0113-7500-49	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0113-7500-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0113-7500-49	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0113-7500-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0113-7500-49	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0113-7500-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0113-7500-49	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0113-7500-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0113-7500-49	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0113-7500-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0113-7500-49	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0113-7500-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0113-7500-49	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0113-7500-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0113-7500-49	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0113-7500-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0113-7500-49	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A210033-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2019-06-12	`caaa826d4ba7…`
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…`

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0113-7500-01	00113750001	20 BLISTER PACK in 1 CARTON (0113-7500-01) > 1 TABLET, CHEWABLE in 1 BLISTER PACK	20 blister pack	2019-07-31	0000-00-00	No	No	Current
0113-7500-49	00113750049	40 BLISTER PACK in 1 CARTON (0113-7500-49) > 1 TABLET, CHEWABLE in 1 BLISTER PACK	40 blister pack	2019-07-31	2023-02-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amazon Children’s Allergy Relief Drug Facts	L. Perrigo Company	2022-11-17	HUMAN OTC DRUG LABEL	2