Claritin Chewable Grape and Bubblegum

Product NDC: 11523-0123
11-digit product format: 115230123
Labeler code: 11523
Product ID: 11523-0123_4526df19-7a6e-0f19-e063-6394a90a3954
Type: HUMAN OTC DRUG
Nonproprietary name: Loratadine
Dosage form: KIT
Route: ORAL
Labeler: Bayer HealthCare LLC.
Application: NDA021891
Marketing category: NDA
Marketing start: 2006-08-23
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 42.

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
N021891-001	CHILDREN'S CLARITIN	LORATADINE	5MG	TABLET, CHEWABLE / ORAL		RLD	2006-08-23
N021891-002	CLARITIN	LORATADINE	10MG	TABLET, CHEWABLE / ORAL		RLD, RS	2018-11-21

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD, RS	2006-08-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD	2018-11-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD, RS	2006-08-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD	2018-11-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD, RS	2006-08-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD	2018-11-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD, RS	2006-08-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD	2018-11-21	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: Claritin Chewable Grape and Bubblegum
Listing expiration: 2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
665078	Internal RxNorm lookup
668469	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
0371368b-dca6-af2f-e063-6394a90a0ac0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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	Strength	SPL version
11523-0123-1	Claritin Chewable Grape and Bubblegum	1 in 1 CARTON	KIT	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11523-0123	CLARITIN CHEWABLE GRAPE AND BUBBLEGUM (LORATADINE) KIT [BAYER HEALTHCARE LLC.]	1	Current NDC, 1 package rows	20230919_0371368b-dca6-af2f-e063-6394a90a0ac0.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Claritin	LORATADINE	Bayer HealthCare LLC.	37732ca2-b454-4215-91a2-c62e0f7a56af	2025-12-05	Warnings	Exact identifier application applno (NDA): 021891 application number: NDA021891
Claritin	LORATADINE	Bayer HealthCare LLC.	20938e05-bc3e-51aa-e054-00144ff88e88	2025-12-05		Exact identifier application applno (NDA): 021891 application number: NDA021891
Claritin Chewable Cool Mint Flavor	LORATADINE	Bayer HealthCare LLC.	98b99bb9-d499-9ab4-e053-2a95a90a6ae6	2025-12-05	Warnings	Exact identifier application applno (NDA): 021891 application number: NDA021891
Claritin Chewable Grape and Bubblegum	LORATADINE	Bayer HealthCare LLC.	0371368b-dca6-af2f-e063-6394a90a0ac0	2025-12-04	Warnings	Exact identifier application applno (NDA): 021891 application number: NDA021891 ndc (product): 11523-0123

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
668469	Claritin Children's 5 MG 24HR Chewable Tablet	PSN	0371368b-dca6-af2f-e063-6394a90a0ac0	2
665078	loratadine 5 MG 24HR Chewable Tablet	PSN	0371368b-dca6-af2f-e063-6394a90a0ac0	2
668469	loratadine 5 MG Chewable Tablet [Claritin]	SBD	0371368b-dca6-af2f-e063-6394a90a0ac0	2
665078	loratadine 5 MG Chewable Tablet	SCD	0371368b-dca6-af2f-e063-6394a90a0ac0	2
668469	Claritin 5 MG Chewable Tablet	SY	0371368b-dca6-af2f-e063-6394a90a0ac0	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
11523-0123-1	11523012301	1 KIT in 1 CARTON (11523-0123-1)	1 kit	2023-09-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Children's Claritin ® Chewables 5mg Grape & Bubblegum UIs 1611948 & 1612741	Bayer HealthCare LLC.	2025-12-04	HUMAN OTC DRUG LABEL	2