Claritin

Product NDC: 11523-4359
11-digit product format: 115234359
Labeler code: 11523
Product ID: 11523-4359_4536cd82-d67c-56be-e063-6294a90a7775
Type: HUMAN OTC DRUG
Nonproprietary name: Loratadine
Dosage form: TABLET
Route: ORAL
Labeler: Bayer HealthCare LLC.
Application: NDA019658
Marketing category: NDA
Marketing start: 1993-04-12
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 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
N019658-002	CLARITIN	LORATADINE	10MG	TABLET / ORAL		RLD, RS	2002-11-27
N019658-003	CLARITIN HIVES RELIEF	LORATADINE	10MG	TABLET / ORAL		RLD, RS	2003-11-19

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	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Claritin
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
206805	Internal RxNorm lookup
311372	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
660ac9df-f1b1-4c89-94dd-9fae0a013f3c	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
11523-4359-1	Claritin	40 in 1 BOTTLE	TABLET	40	12
11523-4359-1	Claritin	1 in 1 CARTON	TABLET	1	12
11523-4359-2	Claritin	1 in 1 CARTON	TABLET	1	12
11523-4359-2	Claritin	100 in 1 BOTTLE	TABLET	100	12
11523-4359-3	Claritin	90 in 1 BOTTLE	TABLET	90	12
11523-4359-3	Claritin	1 in 1 CARTON	TABLET	1	12
11523-4359-4	Claritin	55 in 1 BOTTLE	TABLET	55	12
11523-4359-4	Claritin	1 in 1 CARTON	TABLET	1	12
11523-4359-5	Claritin	1 in 1 CARTON	TABLET	1	12
11523-4359-5	Claritin	85 in 1 BOTTLE	TABLET	85	12
11523-4359-6	Claritin	110 in 1 BOTTLE	TABLET	110	12
11523-4359-6	Claritin	1 in 1 CARTON	TABLET	1	12
11523-4359-7	Claritin	1 in 1 BLISTER PACK	TABLET	1	12
11523-4359-7	Claritin	115 in 1 BOTTLE	TABLET	115	12
11523-4359-8	Claritin	60 in 1 BOTTLE	TABLET	60	12
11523-4359-8	Claritin	2 in 1 BLISTER PACK	TABLET	2	12
11523-4359-9	Claritin	1 in 1 CARTON	TABLET	1	12
11523-4359-9	Claritin	35 in 1 BOTTLE	TABLET	35	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11523-4359-1	EA - Each	11523-4359	ec560d72-229c-43c8-b999-35c4b11a066e	1	2022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Loratadine	ACTIVE INGREDIENT	7AJO3BO7QN	CLARITIN (LORATADINE) TABLET [MSD CONSUMER CARE, INC.]	4
Loratadine	ACTIVE MOIETY	7AJO3BO7QN	CLARITIN (LORATADINE) TABLET [MSD CONSUMER CARE, INC.]	4
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	CLARITIN (LORATADINE) TABLET [MSD CONSUMER CARE, INC.]	4
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	CLARITIN (LORATADINE) TABLET [MSD CONSUMER CARE, INC.]	4
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	CLARITIN (LORATADINE) TABLET [MSD CONSUMER CARE, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11523-4359	CLARITIN (LORATADINE) TABLET [BAYER HEALTHCARE LLC.]	11	Current NDC, Legacy NDC, 18 package rows	20221015_660ac9df-f1b1-4c89-94dd-9fae0a013f3c.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Claritin	LORATADINE	Bayer HealthCare LLC.	660ac9df-f1b1-4c89-94dd-9fae0a013f3c	2025-12-05	Warnings	Exact identifier application applno (NDA): 019658 application number: NDA019658 ndc (product): 11523-4359
Claritin	LORATADINE	Bayer HealthCare LLC	ac32d6f9-f553-4d5c-ad36-575af5ea56de	2025-12-04	Warnings	Exact identifier application applno (NDA): 019658 application number: NDA019658
Claritin	LORATADINE	R J General Corporation	a34e8cb7-4fdf-45be-b288-45d93eef6220	2025-11-17	Warnings	Exact identifier application applno (NDA): 019658 application number: NDA019658
Claritin, BSX Non-Drowsy, 24 Hour	LORATADINE	Lil' Drug Store Products, Inc	f85b0527-107c-4a4a-aad7-61d2f52bad63	2023-03-17	Warnings	Exact identifier application applno (NDA): 019658 application number: NDA019658
Claritin	LORATADINE	Navajo Manufacturing Company	60a5dc14-3f74-8414-e053-2991aa0ad34a	2023-03-01	Warnings	Exact identifier application applno (NDA): 019658 application number: NDA019658
Claritin	LORATADINE	Navajo Manufacturing Company Inc.	219ab9c4-d0c4-4256-ab64-66d0260886bd	2023-03-01	Warnings	Exact identifier application applno (NDA): 019658 application number: NDA019658

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
206805	Claritin 24HR Allergy 10 MG Oral Tablet	PSN	660ac9df-f1b1-4c89-94dd-9fae0a013f3c	12
311372	loratadine 10 MG 24HR Oral Tablet	PSN	660ac9df-f1b1-4c89-94dd-9fae0a013f3c	12
206805	loratadine 10 MG Oral Tablet [Claritin]	SBD	660ac9df-f1b1-4c89-94dd-9fae0a013f3c	12
311372	loratadine 10 MG Oral Tablet	SCD	660ac9df-f1b1-4c89-94dd-9fae0a013f3c	12
206805	Claritin 10 MG 24 HR Oral Tablet	SY	660ac9df-f1b1-4c89-94dd-9fae0a013f3c	12
206805	Claritin 10 MG Oral Tablet	SY	660ac9df-f1b1-4c89-94dd-9fae0a013f3c	12
311372	loratadine 10 MG 24 HR Oral Tablet	SY	660ac9df-f1b1-4c89-94dd-9fae0a013f3c	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11523-4359-1	11523435901	1 BOTTLE in 1 CARTON (11523-4359-1) / 40 TABLET in 1 BOTTLE	1 bottle	1993-04-12	0000-00-00	No	No	Current
11523-4359-2	11523435902	1 BOTTLE in 1 CARTON (11523-4359-2) / 100 TABLET in 1 BOTTLE	1 bottle	1993-04-12	0000-00-00	No	No	Current
11523-4359-3	11523435903	1 BOTTLE in 1 CARTON (11523-4359-3) / 90 TABLET in 1 BOTTLE	1 bottle	2017-11-01	0000-00-00	No	No	Current
11523-4359-4	11523435904	1 BOTTLE in 1 CARTON (11523-4359-4) / 55 TABLET in 1 BOTTLE	1 bottle	2019-02-15	0000-00-00	No	No	Current
11523-4359-5	11523435905	1 BOTTLE in 1 CARTON (11523-4359-5) / 85 TABLET in 1 BOTTLE	1 bottle	2019-02-15	0000-00-00	No	No	Current
11523-4359-6	11523435906	1 BOTTLE in 1 CARTON (11523-4359-6) / 110 TABLET in 1 BOTTLE	1 bottle	2019-12-01	0000-00-00	No	No	Current
11523-4359-7	11523435907	1 BOTTLE in 1 BLISTER PACK (11523-4359-7) / 115 TABLET in 1 BOTTLE	1 bottle	1993-04-12	0000-00-00	No	No	Current
11523-4359-8	11523435908	2 BOTTLE in 1 BLISTER PACK (11523-4359-8) / 60 TABLET in 1 BOTTLE	2 bottle	1993-04-12	0000-00-00	No	No	Current
11523-4359-9	11523435909	1 BOTTLE in 1 CARTON (11523-4359-9) / 35 TABLET in 1 BOTTLE	1 bottle	2019-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Non-Drowsy*Claritin ® loratadine tablets 10 mg/antihistamine	Bayer HealthCare LLC.	2025-12-05	HUMAN OTC DRUG LABEL	12