Claritin

Product NDC: 11523-7202
11-digit product format: 115237202
Labeler code: 11523
Product ID: 11523-7202_45371bc6-b83d-a96d-e063-6294a90a7c40
Type: HUMAN OTC DRUG
Nonproprietary name: Loratadine
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Bayer HealthCare LLC
Application: NDA021993
Marketing category: NDA
Marketing start: 2006-12-12
Substance: LORATADINE
Active strength: 5 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 14 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
2022-04-09 23:13 UTC · source 2022-04-08	unfinished product	product		`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	11523-7202-4	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished product	product		`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished package	package	11523-7202-4	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished product	product		`8fc7167e32ce…`	`e96bbc724034…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished package	package	11523-7202-4	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished product	product		`4184dd79f89f…`	`545327b3e20f…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished package	package	11523-7202-4	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished product	product		`4bd3596a7b87…`	`5c64c6f6865f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished package	package	11523-7202-4	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished product	product		`263afe128892…`	`91768de4ddbe…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished package	package	11523-7202-4	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished product	product		`5b2001dcd8f5…`	`54b53d4dc9e4…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished package	package	11523-7202-4	`5b2001dcd8f5…`	`54b53d4dc9e4…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N021993-001	CLARITIN REDITABS	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD, RS	2006-12-12

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 · 41 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	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Claritin
Brand name suffix: Reditabs
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LORATADINE	5 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
672558	Internal RxNorm lookup
904026	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
7dc04b48-f053-4e4b-a493-9e8286d2a791	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
11523-7202-1	ClaritinReditabs	3 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	3	12
11523-7202-1	ClaritinReditabs	10 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	10	12
11523-7202-3	ClaritinReditabs	10 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	10	12
11523-7202-3	ClaritinReditabs	1 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	1	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11523-7202-1	EA - Each	11523-7202	2d9569c3-1d2b-4a96-a48f-54e4ce505bd9	1	2012-07-24
11523-7202-3	EA - Each	11523-7202	8c62db1c-bc79-4bd8-aae5-46837fb33bf9	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Loratadine	ACTIVE INGREDIENT	7AJO3BO7QN	CLARITIN REDITABS (LORATADINE) TABLET, ORALLY DISINTEGRATING [MSD CONSUMER CARE, INC.]	4
Loratadine	ACTIVE MOIETY	7AJO3BO7QN	CLARITIN REDITABS (LORATADINE) TABLET, ORALLY DISINTEGRATING [MSD CONSUMER CARE, INC.]	4
anhydrous citric acid	INACTIVE INGREDIENT	XF417D3PSL	CLARITIN REDITABS (LORATADINE) TABLET, ORALLY DISINTEGRATING [MSD CONSUMER CARE, INC.]	4
gelatin	INACTIVE INGREDIENT	2G86QN327L	CLARITIN REDITABS (LORATADINE) TABLET, ORALLY DISINTEGRATING [MSD CONSUMER CARE, INC.]	4
mannitol	INACTIVE INGREDIENT	3OWL53L36A	CLARITIN REDITABS (LORATADINE) TABLET, ORALLY DISINTEGRATING [MSD CONSUMER CARE, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11523-7202	CLARITIN REDITABS (LORATADINE) TABLET, ORALLY DISINTEGRATING [BAYER HEALTHCARE LLC]	11	Current NDC, Legacy NDC, 4 package rows	20241208_7dc04b48-f053-4e4b-a493-9e8286d2a791.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Claritin Reditabs	LORATADINE	Bayer HealthCare LLC	7dc04b48-f053-4e4b-a493-9e8286d2a791	2025-12-05	Warnings	Exact identifier application applno (NDA): 021993 application number: NDA021993 ndc (product): 11523-7202

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
904026	Claritin RediTabs 5 MG 12HR Disintegrating Oral Tablet	PSN	7dc04b48-f053-4e4b-a493-9e8286d2a791	12
672558	loratadine 5 MG Disintegrating Oral Tablet	PSN	7dc04b48-f053-4e4b-a493-9e8286d2a791	12
904026	loratadine 5 MG Disintegrating Oral Tablet [Claritin]	SBD	7dc04b48-f053-4e4b-a493-9e8286d2a791	12
672558	loratadine 5 MG Disintegrating Oral Tablet	SCD	7dc04b48-f053-4e4b-a493-9e8286d2a791	12
904026	Claritin 12HR RediTabs 5 MG Disintegrating Oral Tablet	SY	7dc04b48-f053-4e4b-a493-9e8286d2a791	12
904026	Claritin 5 MG Disintegrating Oral Tablet	SY	7dc04b48-f053-4e4b-a493-9e8286d2a791	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11523-7202-1	11523720201	3 BLISTER PACK in 1 CARTON (11523-7202-1) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	3 blister pack	2006-12-12	0000-00-00	No	No	Current
11523-7202-3	11523720203	1 BLISTER PACK in 1 CARTON (11523-7202-3) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	1 blister pack	2006-12-12	0000-00-00	No	No	Current