Claritin Chewable

Product NDC: 11523-4364
11-digit product format: 115234364
Labeler code: 11523
Product ID: 11523-4364_453711b1-0b16-f203-e063-6394a90a34e1
Type: HUMAN OTC DRUG
Nonproprietary name: loratadine
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Bayer HealthCare LLC.
Application: NDA021891
Marketing category: NDA
Marketing start: 2019-12-09
Substance: LORATADINE
Active strength: 10 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 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
Brand name suffix: Cool Mint Flavor
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LORATADINE	10 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2265266	Internal RxNorm lookup
2265267	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
98b99bb9-d499-9ab4-e053-2a95a90a6ae6	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
11523-4364-1	Claritin ChewableCool Mint Flavor	3 in 1 CARTON	TABLET, CHEWABLE	3	5
11523-4364-1	Claritin ChewableCool Mint Flavor	8 in 1 BLISTER PACK	TABLET, CHEWABLE	8	5
11523-4364-2	Claritin ChewableCool Mint Flavor	2 in 1 BLISTER PACK	TABLET, CHEWABLE	2	5
11523-4364-2	Claritin ChewableCool Mint Flavor	1 in 1 CARTON	TABLET, CHEWABLE	1	5
11523-4364-3	Claritin ChewableCool Mint Flavor	4 in 1 BLISTER PACK	TABLET, CHEWABLE	4	5
11523-4364-3	Claritin ChewableCool Mint Flavor	1 in 1 CARTON	TABLET, CHEWABLE	1	5
11523-4364-4	Claritin ChewableCool Mint Flavor	7 in 1 CARTON	TABLET, CHEWABLE	7	5
11523-4364-4	Claritin ChewableCool Mint Flavor	8 in 1 BLISTER PACK	TABLET, CHEWABLE	8	5
11523-4364-5	Claritin ChewableCool Mint Flavor	8 in 1 CARTON	TABLET, CHEWABLE	8	5
11523-4364-5	Claritin ChewableCool Mint Flavor	8 in 1 BLISTER PACK	TABLET, CHEWABLE	8	5
11523-4364-6	Claritin ChewableCool Mint Flavor	1 in 1 CARTON	TABLET, CHEWABLE	1	5
11523-4364-6	Claritin ChewableCool Mint Flavor	8 in 1 BLISTER PACK	TABLET, CHEWABLE	8	5
11523-4364-7	Claritin ChewableCool Mint Flavor	2 in 1 BLISTER PACK	TABLET, CHEWABLE	2	5
11523-4364-7	Claritin ChewableCool Mint Flavor	1 in 1 POUCH	TABLET, CHEWABLE	1	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11523-4364-1	EA - Each	11523-4364	a888024d-d3f7-43cb-9107-b6e9040b6de0	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11523-4364	CLARITIN CHEWABLE COOL MINT FLAVOR (LORATADINE) TABLET, CHEWABLE [BAYER HEALTHCARE LLC.]	4	Current NDC, Legacy NDC, 14 package rows	20231214_98b99bb9-d499-9ab4-e053-2a95a90a6ae6.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 ndc (product): 11523-4364
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

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
2265267	Claritin 10 MG Chewable Tablet	PSN	98b99bb9-d499-9ab4-e053-2a95a90a6ae6	5
2265266	loratadine 10 MG Chewable Tablet	PSN	98b99bb9-d499-9ab4-e053-2a95a90a6ae6	5
2265267	loratadine 10 MG Chewable Tablet [Claritin]	SBD	98b99bb9-d499-9ab4-e053-2a95a90a6ae6	5
2265266	loratadine 10 MG Chewable Tablet	SCD	98b99bb9-d499-9ab4-e053-2a95a90a6ae6	5
2265267	Claritin 10 MG Chewable Tablet	SY	98b99bb9-d499-9ab4-e053-2a95a90a6ae6	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11523-4364-1	11523436401	3 BLISTER PACK in 1 CARTON (11523-4364-1) / 8 TABLET, CHEWABLE in 1 BLISTER PACK	3 blister pack	2019-12-09	0000-00-00	No	No	Current
11523-4364-2	11523436402	1 BLISTER PACK in 1 CARTON (11523-4364-2) / 2 TABLET, CHEWABLE in 1 BLISTER PACK	1 blister pack	2019-12-09	0000-00-00	No	No	Current
11523-4364-3	11523436403	1 BLISTER PACK in 1 CARTON (11523-4364-3) / 4 TABLET, CHEWABLE in 1 BLISTER PACK	1 blister pack	2019-12-09	0000-00-00	Yes	No	Current
11523-4364-4	11523436404	7 BLISTER PACK in 1 CARTON (11523-4364-4) / 8 TABLET, CHEWABLE in 1 BLISTER PACK	7 blister pack	2019-12-09	0000-00-00	No	No	Current
11523-4364-5	11523436405	8 BLISTER PACK in 1 CARTON (11523-4364-5) / 8 TABLET, CHEWABLE in 1 BLISTER PACK	8 blister pack	2019-12-09	0000-00-00	No	No	Current
11523-4364-6	11523436406	1 BLISTER PACK in 1 CARTON (11523-4364-6) / 8 TABLET, CHEWABLE in 1 BLISTER PACK	1 blister pack	2019-12-09	0000-00-00	No	No	Current
11523-4364-7	11523436407	1 BLISTER PACK in 1 POUCH (11523-4364-7) / 2 TABLET, CHEWABLE in 1 BLISTER PACK	1 blister pack	2019-12-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Claritin 10mg Cool Mint Chewable (1613932)	Bayer HealthCare LLC.	2025-12-05	HUMAN OTC DRUG LABEL	5