Claritin-D

Product NDC: 11523-7162
11-digit product format: 115237162
Labeler code: 11523
Product ID: 11523-7162_45371982-daab-f344-e063-6394a90a2f41
Type: HUMAN OTC DRUG
Nonproprietary name: Loratadine and pseudoephedrine sulfate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Bayer HealthCare LLC.
Application: NDA019670
Marketing category: NDA
Marketing start: 2009-12-01
Substance: LORATADINE; PSEUDOEPHEDRINE SULFATE
Active strength: 5; 120 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

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
N019670-002	CLARITIN-D	LORATADINE; PSEUDOEPHEDRINE SULFATE	5MG;120MG	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	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LORATADINE	5 mg/1
PSEUDOEPHEDRINE SULFATE	120 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
1242399	Internal RxNorm lookup
1242406	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
a7125705-01ff-4418-8c53-9209c2bbb484	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
11523-7162-1	Claritin-D12 Hour	10 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	10	10
11523-7162-1	Claritin-D12 Hour	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	10
11523-7162-2	Claritin-D12 Hour	2 in 1 CARTON	TABLET, EXTENDED RELEASE	2	10
11523-7162-2	Claritin-D12 Hour	10 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	10	10
11523-7162-3	Claritin-D12 Hour	3 in 1 CARTON	TABLET, EXTENDED RELEASE	3	10
11523-7162-3	Claritin-D12 Hour	10 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	10	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11523-7162-1	EA - Each	11523-7162	85cce7f3-cec5-4281-aaa0-08796678607d	1	2012-07-24
11523-7162-2	EA - Each	11523-7162	c215d904-7907-4d87-a34a-651e85e00f12	1	2012-07-24
11523-7162-3	EA - Each	11523-7162	a7d669e2-7d96-4d35-9050-886853111333	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Loratadine	ACTIVE INGREDIENT	7AJO3BO7QN	CLARITIN-D 12 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]	2
pseudoephedrine sulfate	ACTIVE INGREDIENT	Y9DL7QPE6B	CLARITIN-D 12 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]	2
Loratadine	ACTIVE MOIETY	7AJO3BO7QN	CLARITIN-D 12 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]	2
pseudoephedrine	ACTIVE MOIETY	7CUC9DDI9F	CLARITIN-D 12 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]	2
calcium phosphate, dibasic, anhydrous	INACTIVE INGREDIENT	L11K75P92J	CLARITIN-D 12 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]	2
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	CLARITIN-D 12 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]	2
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	CLARITIN-D 12 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]	2
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	CLARITIN-D 12 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	CLARITIN-D 12 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]	2
povidones	INACTIVE INGREDIENT	FZ989GH94E	CLARITIN-D 12 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]	2
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	CLARITIN-D 12 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11523-7162	CLARITIN-D 12 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [BAYER HEALTHCARE LLC.]	9	Current NDC, Legacy NDC, 6 package rows	20241208_a7125705-01ff-4418-8c53-9209c2bbb484.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 12 Hour	LORATADINE AND PSEUDOEPHEDRINE SULFATE	Bayer HealthCare LLC.	a7125705-01ff-4418-8c53-9209c2bbb484	2025-12-05	Warnings	Exact identifier application applno (NDA): 019670 application number: NDA019670 ndc (product): 11523-7162

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
1242406	Claritin-D 5 MG / 120 MG 12HR Extended Release Oral Tablet	PSN	a7125705-01ff-4418-8c53-9209c2bbb484	10
1242399	pseudoephedrine sulfate 120 MG / loratadine 5 MG 12HR Extended Release Oral Tablet	PSN	a7125705-01ff-4418-8c53-9209c2bbb484	10
1242406	12 HR loratadine 5 MG / pseudoephedrine sulfate 120 MG Extended Release Oral Tablet [Claritin-D]	SBD	a7125705-01ff-4418-8c53-9209c2bbb484	10
1242399	12 HR loratadine 5 MG / pseudoephedrine sulfate 120 MG Extended Release Oral Tablet	SCD	a7125705-01ff-4418-8c53-9209c2bbb484	10
1242406	Claritin-D (loratadine 5 MG / pseudoephedrine sulfate 120 MG) 12 HR Extended Release Oral Tablet	SY	a7125705-01ff-4418-8c53-9209c2bbb484	10
1242399	loratadine 5 MG / pseudoephedrine sulfate 120 MG 12 HR Extended Release Oral Tablet	SY	a7125705-01ff-4418-8c53-9209c2bbb484	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11523-7162-1	11523716201	1 BLISTER PACK in 1 CARTON (11523-7162-1) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	1 blister pack	2009-12-01	0000-00-00	No	No	Current
11523-7162-2	11523716202	2 BLISTER PACK in 1 CARTON (11523-7162-2) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	2 blister pack	2009-12-01	0000-00-00	No	No	Current
11523-7162-3	11523716203	3 BLISTER PACK in 1 CARTON (11523-7162-3) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	3 blister pack	2009-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Claritin-D ® 12 Hour	Bayer HealthCare LLC.	2025-12-05	HUMAN OTC DRUG LABEL	10
Claritin-D ® 12 Hour	REMEDYREPACK INC.	2022-11-01	HUMAN OTC DRUG LABEL	1