Claritin

Product NDC: 11523-6655
11-digit product format: 115236655
Labeler code: 11523
Product ID: 11523-6655_4523713e-42b4-1ee9-e063-6394a90abb7d
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 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
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 · 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	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`caaa826d4ba7…`
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…`

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
ac32d6f9-f553-4d5c-ad36-575af5ea56de	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
11523-6655-1	Claritin	1 in 1 POUCH	TABLET	1	9
11523-6655-1	Claritin	1 in 1 BLISTER PACK	TABLET	1	9
11523-6655-2	Claritin	70 in 1 BOTTLE	TABLET	70	9
11523-6655-2	Claritin	1 in 1 CARTON	TABLET	1	9
11523-6655-3	Claritin	2 in 1 BLISTER PACK	TABLET	2	9
11523-6655-3	Claritin	45 in 1 BOTTLE	TABLET	45	9
11523-6655-4	Claritin	105 in 1 BOTTLE	TABLET	105	9
11523-6655-4	Claritin	1 in 1 BLISTER PACK	TABLET	1	9
11523-6655-5	Claritin	1 in 1 CARTON	TABLET	1	9
11523-6655-5	Claritin	60 in 1 BOTTLE	TABLET	60	9
11523-6655-6	Claritin	105 in 1 BOTTLE	TABLET	105	9
11523-6655-6	Claritin	1 in 1 BLISTER PACK	TABLET	1	9
11523-6655-7	Claritin	25 in 1 BOX	TABLET	25	9
11523-6655-7	Claritin	1 in 1 POUCH	TABLET	1	9
11523-6655-8	Claritin	1 in 1 CARTON	TABLET	1	9
11523-6655-8	Claritin	30 in 1 BOTTLE	TABLET	30	9
11523-6655-9	Claritin	1 in 1 CARTON	TABLET	1	9
11523-6655-9	Claritin	80 in 1 BOTTLE	TABLET	80	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11523-6655-1	EA - Each	11523-6655	dde71ab6-6809-4ac7-a7d9-9d9c742a2b8f	1	2024-04-05
11523-6655-2	EA - Each	11523-6655	5605a8ba-b61d-432a-ad81-9fb5116f9d46	1	2015-03-03
11523-6655-6	EA - Each	11523-6655	91e9062d-e1f2-4e78-9761-7f65d491a10a	1	2015-10-02
11523-6655-8	EA - Each	11523-6655	ea2498f1-91fa-4f87-ab4c-62a689bc2308	1	2017-06-15

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.]	5
Loratadine	ACTIVE MOIETY	7AJO3BO7QN	CLARITIN (LORATADINE) TABLET [MSD CONSUMER CARE, INC.]	5
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	CLARITIN (LORATADINE) TABLET [MSD CONSUMER CARE, INC.]	5
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	CLARITIN (LORATADINE) TABLET [MSD CONSUMER CARE, INC.]	5
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	CLARITIN (LORATADINE) TABLET [MSD CONSUMER CARE, INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11523-6655	CLARITIN (LORATADINE) TABLET [BAYER HEALTHCARE LLC]	8	Current NDC, Legacy NDC, 18 package rows	20221014_ac32d6f9-f553-4d5c-ad36-575af5ea56de.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
Claritin	LORATADINE	Bayer HealthCare LLC	ac32d6f9-f553-4d5c-ad36-575af5ea56de	2025-12-04	Warnings	Exact identifier application applno (NDA): 019658 application number: NDA019658 ndc (product): 11523-6655
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	ac32d6f9-f553-4d5c-ad36-575af5ea56de	9
311372	loratadine 10 MG 24HR Oral Tablet	PSN	ac32d6f9-f553-4d5c-ad36-575af5ea56de	9
206805	loratadine 10 MG Oral Tablet [Claritin]	SBD	ac32d6f9-f553-4d5c-ad36-575af5ea56de	9
311372	loratadine 10 MG Oral Tablet	SCD	ac32d6f9-f553-4d5c-ad36-575af5ea56de	9
206805	Claritin 10 MG 24 HR Oral Tablet	SY	ac32d6f9-f553-4d5c-ad36-575af5ea56de	9
206805	Claritin 10 MG Oral Tablet	SY	ac32d6f9-f553-4d5c-ad36-575af5ea56de	9
311372	loratadine 10 MG 24 HR Oral Tablet	SY	ac32d6f9-f553-4d5c-ad36-575af5ea56de	9
206805	Claritin 24HR Allergy 10 MG Oral Tablet	PSN	a34e8cb7-4fdf-45be-b288-45d93eef6220	4
311372	loratadine 10 MG 24HR Oral Tablet	PSN	a34e8cb7-4fdf-45be-b288-45d93eef6220	4
206805	loratadine 10 MG Oral Tablet [Claritin]	SBD	a34e8cb7-4fdf-45be-b288-45d93eef6220	4
311372	loratadine 10 MG Oral Tablet	SCD	a34e8cb7-4fdf-45be-b288-45d93eef6220	4
206805	Claritin 10 MG 24 HR Oral Tablet	SY	a34e8cb7-4fdf-45be-b288-45d93eef6220	4
206805	Claritin 10 MG Oral Tablet	SY	a34e8cb7-4fdf-45be-b288-45d93eef6220	4
311372	loratadine 10 MG 24 HR Oral Tablet	SY	a34e8cb7-4fdf-45be-b288-45d93eef6220	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11523-6655-1	11523665501	1 BLISTER PACK in 1 POUCH (11523-6655-1) / 1 TABLET in 1 BLISTER PACK	1 blister pack	1993-04-12	0000-00-00	No	No	Current
11523-6655-2	11523665502	1 BOTTLE in 1 CARTON (11523-6655-2) / 70 TABLET in 1 BOTTLE	1 bottle	1993-04-12	0000-00-00	No	No	Current
11523-6655-3	11523665503	2 BOTTLE in 1 BLISTER PACK (11523-6655-3) / 45 TABLET in 1 BOTTLE	2 bottle	1993-04-12	0000-00-00	No	No	Current
11523-6655-4	11523665504	1 BOTTLE in 1 BLISTER PACK (11523-6655-4) / 105 TABLET in 1 BOTTLE	1 bottle	1993-04-12	0000-00-00	No	No	Current
11523-6655-5	11523665505	1 BOTTLE in 1 CARTON (11523-6655-5) / 60 TABLET in 1 BOTTLE	1 bottle	1993-04-12	0000-00-00	No	No	Current
11523-6655-6	11523665506	1 BOTTLE in 1 BLISTER PACK (11523-6655-6) / 105 TABLET in 1 BOTTLE	1 bottle	1993-04-12	0000-00-00	No	No	Current
11523-6655-7	11523665507	25 POUCH in 1 BOX (11523-6655-7) / 1 TABLET in 1 POUCH	25 pouch	1993-04-12	0000-00-00	No	No	Current
11523-6655-8	11523665508	1 BOTTLE in 1 CARTON (11523-6655-8) / 30 TABLET in 1 BOTTLE	1 bottle	1993-04-12	0000-00-00	No	No	Current
11523-6655-9	11523665509	1 BOTTLE in 1 CARTON (11523-6655-9) / 80 TABLET in 1 BOTTLE	1 bottle	1993-04-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Non-Drowsy* Claritin ®	Bayer HealthCare LLC	2025-12-04	HUMAN OTC DRUG LABEL	9
Drug Facts	R J General Corporation	2025-11-17	HUMAN OTC DRUG LABEL	4