CLARINEX-D 12 HOUR

Product NDC: 0085-1322
11-digit product format: 000851322
Labeler code: 0085
Product ID: 0085-1322_14500ece-eea2-4589-8278-fbce510c7c7d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: desloratadine and pseudoephedrine sulfate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Merck Sharp & Dohme Corp.
Application: NDA021313
Marketing category: NDA
Marketing start: 2006-02-01
Marketing end: 0000-00-00
Substance: DESLORATADINE; PSEUDOEPHEDRINE SULFATE
Active strength: 3 mg/1; mg/1
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0085-1322		D	Discontinued by firm		2026-08-03
excluded package	package	0085-1322	0085-1322-01	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 · 24 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0085-1322-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0085-1322-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0085-1322-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0085-1322-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0085-1322-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0085-1322-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0085-1322-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0085-1322-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0085-1322-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0085-1322-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0085-1322-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0085-1322-01	`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
N021313-001	CLARINEX-D 12 HOUR	DESLORATADINE; PSEUDOEPHEDRINE SULFATE	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2006-02-01

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	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021313-001	6100274	2019-07-07		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021313-001	6100274*PED	2020-01-07		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021313-001	7618649	2020-12-19	U-1017	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021313-001	8187630	2020-12-19	U-1017	Drug product	2012-06-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021313-001	6709676	2021-02-18	U-707	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021313-001	7618649*PED	2021-06-19		Pediatric extension		`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021313-001	6709676	2021-02-18	U-707	Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021313-001	7618649*PED	2021-06-19		Pediatric extension		`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021313-001	6709676	2021-02-18	U-707	Drug product		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021313-001	7618649*PED	2021-06-19		Pediatric extension		`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021313-001	6709676	2021-02-18	U-707	Drug product		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021313-001	7618649*PED	2021-06-19		Pediatric extension		`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021313-001	6100274*PED	2020-01-07		Pediatric extension		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021313-001	7618649	2020-12-19	U-1017	Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021313-001	8187630	2020-12-19	U-1017	Drug product	2012-06-28	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021313-001	6709676	2021-02-18	U-707	Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021313-001	7618649*PED	2021-06-19		Pediatric extension		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021313-001	6100274*PED	2020-01-07		Pediatric extension		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021313-001	7618649	2020-12-19	U-1017	Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021313-001	8187630	2020-12-19	U-1017	Drug product	2012-06-28	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021313-001	6709676	2021-02-18	U-707	Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021313-001	7618649*PED	2021-06-19		Pediatric extension		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021313-001	6100274	2019-07-07		Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021313-001	6100274*PED	2020-01-07		Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021313-001	7618649	2020-12-19	U-1017	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021313-001	8187630	2020-12-19	U-1017	Drug product	2012-06-28	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021313-001	6709676	2021-02-18	U-707	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021313-001	7618649*PED	2021-06-19		Pediatric extension		`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021313-001	6100274	2019-07-07		Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021313-001	6100274*PED	2020-01-07		Pediatric extension		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021313-001	7618649	2020-12-19	U-1017	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021313-001	8187630	2020-12-19	U-1017	Drug product	2012-06-28	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021313-001	6709676	2021-02-18	U-707	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021313-001	7618649*PED	2021-06-19		Pediatric extension		`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021313-001	6100274	2019-07-07		Drug product		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021313-001	6100274*PED	2020-01-07		Pediatric extension		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021313-001	7618649	2020-12-19	U-1017	Drug product		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021313-001	8187630	2020-12-19	U-1017	Drug product	2012-06-28	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021313-001	6709676	2021-02-18	U-707	Drug product		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021313-001	7618649*PED	2021-06-19		Pediatric extension		`ea99ee380514…`

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
01632a31-f1c5-44ea-aa59-efded68c0797	Product name	1	20150716
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
c6d3c427-3d3d-6bcf-7aa8-536d42cf1fd8	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0085-1322-01	EA - Each	0085-1322	af15910f-fd4a-4170-a0b9-cdf8911517ab	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
desloratadine	ACTIVE INGREDIENT	FVF865388R	CLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	6
pseudoephedrine sulfate	ACTIVE INGREDIENT	Y9DL7QPE6B	CLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	6
desloratadine	ACTIVE MOIETY	FVF865388R	CLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	6
pseudoephedrine	ACTIVE MOIETY	7CUC9DDI9F	CLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	6
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	CLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	6
anhydrous citric acid	INACTIVE INGREDIENT	XF417D3PSL	CLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	6
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	CLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	6
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	CLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	6
FD&C Blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	CLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	6
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	CLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	6
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	CLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	6
povidones	INACTIVE INGREDIENT	FZ989GH94E	CLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	6
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	CLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	6
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	CLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	6
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	CLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	6
DESLORATADINE	ACTIVE INGREDIENT	FVF865388R	CLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
PSEUDOEPHEDRINE SULFATE	ACTIVE INGREDIENT	Y9DL7QPE6B	CLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
DESLORATADINE	ACTIVE MOIETY	FVF865388R	CLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	CLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	CLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	CLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	CLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	CLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	CLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1

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
CLARINEX-D 12 HOUR	DESLORATADINE AND PSEUDOEPHEDRINE SULFATE	Organon LLC	1af66b7a-4ab8-40d8-abdd-22d3310228a8	2025-11-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021313 application number: NDA021313

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
FVF865388R	DESLORATADINE	100643-71-8	DESLORATADINE
Y9DL7QPE6B	PSEUDOEPHEDRINE SULFATE	7460-12-0	PSEUDOEPHEDRINE SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1112250	CLARINEX-D 2.5 MG / 120 MG 12HR Extended Release Oral Tablet	PSN	c7230a68-a3ac-4dce-9e72-6e21f0b25f45	1
1112248	desloratadine 2.5 MG / pseudoephedrine sulfate 120 MG 12HR Extended Release Oral Tablet	PSN	c7230a68-a3ac-4dce-9e72-6e21f0b25f45	1
1112250	12 HR desloratadine 2.5 MG / pseudoephedrine sulfate 120 MG Extended Release Oral Tablet [Clarinex-D]	SBD	c7230a68-a3ac-4dce-9e72-6e21f0b25f45	1
1112248	12 HR desloratadine 2.5 MG / pseudoephedrine sulfate 120 MG Extended Release Oral Tablet	SCD	c7230a68-a3ac-4dce-9e72-6e21f0b25f45	1
1112250	Clarinex-D (desloratadine 2.5 MG / pseudoephedrine sulfate 120 MG) 12 HR Extended Release Oral Tablet	SY	c7230a68-a3ac-4dce-9e72-6e21f0b25f45	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0085-1322-01	00085132201	100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0085-1322-01)	2006-02-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CLARINEX-D 12 HOUR	Merck Sharp & Dohme Corp.	2020-11-16	HUMAN PRESCRIPTION DRUG LABEL	14
Clarinex-D 12 Hour	Physicians Total Care, Inc.	2009-12-30	HUMAN PRESCRIPTION DRUG LABEL	1