Claritin-D

Product NDC: 11523-4332
Requested package NDC: 11523-4332-1
11-digit product format: 115234332
Labeler code: 11523
Product ID: 11523-4332_45370575-1a5d-c6f1-e063-6394a90a24c4
Type: HUMAN OTC DRUG
Nonproprietary name: Loratadine and pseudoephedrine sulfate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Bayer HealthCare LLC.
Application: NDA020470
Marketing category: NDA
Marketing start: 2009-12-01
Substance: LORATADINE; PSEUDOEPHEDRINE SULFATE
Active strength: 10; 240 mg/1; mg/1
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	11523-4332	11523-4332-1	D	Discontinued by firm		2026-08-03

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N020470-002	CLARITIN-D 24 HOUR	LORATADINE; PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2002-11-27

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	N020470-002	CLARITIN-D 24 HOUR	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020470-002	CLARITIN-D 24 HOUR	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020470-002	CLARITIN-D 24 HOUR	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020470-002	CLARITIN-D 24 HOUR	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020470-002	CLARITIN-D 24 HOUR	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020470-002	CLARITIN-D 24 HOUR	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020470-002	CLARITIN-D 24 HOUR	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020470-002	CLARITIN-D 24 HOUR	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020470-002	CLARITIN-D 24 HOUR	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020470-002	CLARITIN-D 24 HOUR	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020470-002	CLARITIN-D 24 HOUR	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020470-002	CLARITIN-D 24 HOUR	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020470-002	CLARITIN-D 24 HOUR	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020470-002	CLARITIN-D 24 HOUR	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020470-002	CLARITIN-D 24 HOUR	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020470-002	CLARITIN-D 24 HOUR	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020470-002	CLARITIN-D 24 HOUR	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020470-002	CLARITIN-D 24 HOUR	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020470-002	CLARITIN-D 24 HOUR	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020470-002	CLARITIN-D 24 HOUR	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020470-002	CLARITIN-D 24 HOUR	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020470-002	CLARITIN-D 24 HOUR	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020470-002	CLARITIN-D 24 HOUR	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020470-002	CLARITIN-D 24 HOUR	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020470-002	CLARITIN-D 24 HOUR	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020470-002	CLARITIN-D 24 HOUR	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020470-002	CLARITIN-D 24 HOUR	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020470-002	CLARITIN-D 24 HOUR	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020470-002	CLARITIN-D 24 HOUR	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020470-002	CLARITIN-D 24 HOUR	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020470-002	CLARITIN-D 24 HOUR	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020470-002	CLARITIN-D 24 HOUR	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020470-002	CLARITIN-D 24 HOUR	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020470-002	CLARITIN-D 24 HOUR	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020470-002	CLARITIN-D 24 HOUR	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020470-002	CLARITIN-D 24 HOUR	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020470-002	CLARITIN-D 24 HOUR	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020470-002	CLARITIN-D 24 HOUR	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020470-002	CLARITIN-D 24 HOUR	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020470-002	CLARITIN-D 24 HOUR	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Claritin-D
Brand name suffix: 24 Hour
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LORATADINE	10 mg/1
PSEUDOEPHEDRINE SULFATE	240 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7AJO3BO7QN	Internal UNII lookup
Y9DL7QPE6B	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1117562	Internal RxNorm lookup
1242391	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
f046a807-ab8c-0620-e053-2a95a90a9d3c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66	Product name	1	20140508
70a83adc-6047-bbea-5a08-dfd304aa47d2	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	Product name	1	20140508
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
11523-4332-1	Claritin-D24 Hour	5 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	5	11
11523-4332-1	Claritin-D24 Hour	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	11
11523-4332-2	Claritin-D24 Hour	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	11
11523-4332-2	Claritin-D24 Hour	10 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	10	11
11523-4332-3	Claritin-D24 Hour	5 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	5	11
11523-4332-3	Claritin-D24 Hour	3 in 1 CARTON	TABLET, EXTENDED RELEASE	3	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11523-4332-1	EA - Each	11523-4332	40164527-e89f-4a62-a521-2780a126ab2f	1	2014-02-04
11523-4332-2	EA - Each	11523-4332	b6e19e95-1862-4d66-9678-e88699aa923f	1	2014-02-04
11523-4332-3	EA - Each	11523-4332	51f9fc16-f263-466f-a344-dfc904651d11	1	2014-02-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11523-4332	CLARITIN-D 24 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [BAYER HEALTHCARE LLC.]	10	Current NDC, Legacy NDC, 6 package rows	20241208_f046a807-ab8c-0620-e053-2a95a90a9d3c.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-D 24 Hour	LORATADINE AND PSEUDOEPHEDRINE SULFATE	Bayer HealthCare LLC.	f046a807-ab8c-0620-e053-2a95a90a9d3c	2025-12-05	Warnings	Exact identifier application applno (NDA): 020470 application number: NDA020470 ndc (package): 11523-4332-1 ndc (product): 11523-4332 ndc11 (package): 11523433201

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7AJO3BO7QN	LORATADINE	79794-75-5	LORATADINE
Y9DL7QPE6B	PSEUDOEPHEDRINE SULFATE	7460-12-0	PSEUDOEPHEDRINE SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1242391	Claritin-D 10 MG / 240 MG 24HR Extended Release Oral Tablet	PSN	f046a807-ab8c-0620-e053-2a95a90a9d3c	11
1117562	pseudoephedrine sulfate 240 MG / loratadine 10 MG 24HR Extended Release Oral Tablet	PSN	f046a807-ab8c-0620-e053-2a95a90a9d3c	11
1242391	24 HR loratadine 10 MG / pseudoephedrine sulfate 240 MG Extended Release Oral Tablet [Claritin-D]	SBD	f046a807-ab8c-0620-e053-2a95a90a9d3c	11
1117562	24 HR loratadine 10 MG / pseudoephedrine sulfate 240 MG Extended Release Oral Tablet	SCD	f046a807-ab8c-0620-e053-2a95a90a9d3c	11
1242391	Claritin-D (loratadine 10 MG / pseudoephedrine sulfate 240 MG) 24 HR Extended Release Oral Tablet	SY	f046a807-ab8c-0620-e053-2a95a90a9d3c	11
1117562	loratadine 10 MG / pseudoephedrine sulfate 240 MG 24 HR Extended Release Oral Tablet	SY	f046a807-ab8c-0620-e053-2a95a90a9d3c	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11523-4332-1	11523433201	1 BLISTER PACK in 1 CARTON (11523-4332-1) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	1 blister pack	2009-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Claritin-D ® 24 Hour	Bayer HealthCare LLC.	2025-12-05	HUMAN OTC DRUG LABEL	11
Claritin-D ® 24 Hour	REMEDYREPACK INC.	2022-11-01	HUMAN OTC DRUG LABEL	4