Clarinex

Product NDC: 0085-1264
11-digit product format: 000851264
Labeler code: 0085
Product ID: 0085-1264_2384f6a9-22a8-4737-9236-c0c6b93cbc62
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Desloratadine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Merck Sharp & Dohme Corp.
Application: NDA021165
Marketing category: NDA
Marketing start: 2001-12-21
Marketing end: 0000-00-00
Substance: DESLORATADINE
Active strength: 5 mg/1
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0085-1264		D	Discontinued by firm	2026-08-17
excluded package	package	0085-1264	0085-1264-01	D	Discontinued by firm	2026-08-17
excluded package	package	0085-1264	0085-1264-02	D	Discontinued by firm	2026-08-17

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 · 36 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	0085-1264-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0085-1264-02	`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	0085-1264-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0085-1264-02	`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	0085-1264-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0085-1264-02	`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	0085-1264-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0085-1264-02	`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	0085-1264-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0085-1264-02	`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	0085-1264-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0085-1264-02	`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	0085-1264-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0085-1264-02	`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	0085-1264-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0085-1264-02	`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	0085-1264-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0085-1264-02	`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	0085-1264-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0085-1264-02	`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	0085-1264-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0085-1264-02	`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	0085-1264-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0085-1264-02	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N021165-001	CLARINEX	DESLORATADINE	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N021165-001	AB

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N021165-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021165-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021165-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021165-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021165-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021165-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021165-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021165-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021165-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021165-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021165-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021165-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021165-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021165-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021165-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021165-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021165-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021165-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021165-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021165-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021165-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021165-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021165-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021165-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021165-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021165-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021165-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021165-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021165-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021165-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021165-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021165-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021165-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021165-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021165-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021165-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021165-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021165-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021165-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021165-001	AB	1	`e64feba35796…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021165-001	6100274	2019-07-07			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021165-001	7405223	2019-07-07	U-886		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021165-001	6100274*PED	2020-01-07		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021165-001	7405223*PED	2020-01-07		Pediatric extension	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021165-001	6100274*PED	2020-01-07		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021165-001	7405223*PED	2020-01-07		Pediatric extension	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021165-001	6100274*PED	2020-01-07		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021165-001	7405223*PED	2020-01-07		Pediatric extension	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021165-001	6100274	2019-07-07			`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021165-001	7405223	2019-07-07	U-886		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021165-001	6100274*PED	2020-01-07		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021165-001	7405223*PED	2020-01-07		Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021165-001	6100274	2019-07-07			`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021165-001	7405223	2019-07-07	U-886		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021165-001	6100274*PED	2020-01-07		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021165-001	7405223*PED	2020-01-07		Pediatric extension	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021165-001	6100274	2019-07-07			`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021165-001	7405223	2019-07-07	U-886		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021165-001	6100274*PED	2020-01-07		Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021165-001	7405223*PED	2020-01-07		Pediatric extension	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
01632a31-f1c5-44ea-aa59-efded68c0797	Product name	1	20150716
4f26f669-fc6c-40ef-9e26-1c7b2390ee66	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	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
0085-1264-01	EA - Each	0085-1264	a52a2601-c79a-434d-bde1-5c09cea2a471	1	2012-07-24
0085-1264-02	EA - Each	0085-1264	45468c58-f299-4135-83ef-18e6ba926b4b	1	2012-07-24
0085-1264-03	EA - Each	0085-1264	30cfda1d-549b-438e-8225-2ce37a778509	1	2012-07-24
0085-1264-04	EA - Each	0085-1264	06a454bb-7e67-4dd6-9099-6cb655adc720	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Desloratadine	ACTIVE INGREDIENT	FVF865388R	CLARINEX (DESLORATADINE) TABLET, FILM COATED CLARINEX (DESLORATADINE) SOLUTION [MERCK SHARP & DOHME CORP.]	14
Desloratadine	ACTIVE MOIETY	FVF865388R	CLARINEX (DESLORATADINE) TABLET, FILM COATED CLARINEX (DESLORATADINE) SOLUTION [MERCK SHARP & DOHME CORP.]	14
Aluminum Oxide	INACTIVE INGREDIENT	LMI26O6933	CLARINEX (DESLORATADINE) TABLET, FILM COATED CLARINEX (DESLORATADINE) SOLUTION [MERCK SHARP & DOHME CORP.]	14
anhydrous citric acid	INACTIVE INGREDIENT	XF417D3PSL	CLARINEX (DESLORATADINE) TABLET, FILM COATED CLARINEX (DESLORATADINE) SOLUTION [MERCK SHARP & DOHME CORP.]	14
calcium phosphate, dibasic, dihydrate	INACTIVE INGREDIENT	O7TSZ97GEP	CLARINEX (DESLORATADINE) TABLET, FILM COATED CLARINEX (DESLORATADINE) SOLUTION [MERCK SHARP & DOHME CORP.]	14
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	CLARINEX (DESLORATADINE) TABLET, FILM COATED CLARINEX (DESLORATADINE) SOLUTION [MERCK SHARP & DOHME CORP.]	14
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	CLARINEX (DESLORATADINE) TABLET, FILM COATED CLARINEX (DESLORATADINE) SOLUTION [MERCK SHARP & DOHME CORP.]	14
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	CLARINEX (DESLORATADINE) TABLET, FILM COATED CLARINEX (DESLORATADINE) SOLUTION [MERCK SHARP & DOHME CORP.]	14
FD&C Blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	CLARINEX (DESLORATADINE) TABLET, FILM COATED CLARINEX (DESLORATADINE) SOLUTION [MERCK SHARP & DOHME CORP.]	14
FD&C Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	CLARINEX (DESLORATADINE) TABLET, FILM COATED CLARINEX (DESLORATADINE) SOLUTION [MERCK SHARP & DOHME CORP.]	14
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	CLARINEX (DESLORATADINE) TABLET, FILM COATED CLARINEX (DESLORATADINE) SOLUTION [MERCK SHARP & DOHME CORP.]	14
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	CLARINEX (DESLORATADINE) TABLET, FILM COATED CLARINEX (DESLORATADINE) SOLUTION [MERCK SHARP & DOHME CORP.]	14
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	CLARINEX (DESLORATADINE) TABLET, FILM COATED CLARINEX (DESLORATADINE) SOLUTION [MERCK SHARP & DOHME CORP.]	14
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	CLARINEX (DESLORATADINE) TABLET, FILM COATED CLARINEX (DESLORATADINE) SOLUTION [MERCK SHARP & DOHME CORP.]	14
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	CLARINEX (DESLORATADINE) TABLET, FILM COATED CLARINEX (DESLORATADINE) SOLUTION [MERCK SHARP & DOHME CORP.]	14
sorbitol	INACTIVE INGREDIENT	506T60A25R	CLARINEX (DESLORATADINE) TABLET, FILM COATED CLARINEX (DESLORATADINE) SOLUTION [MERCK SHARP & DOHME CORP.]	14
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	CLARINEX (DESLORATADINE) TABLET, FILM COATED CLARINEX (DESLORATADINE) SOLUTION [MERCK SHARP & DOHME CORP.]	14
talc	INACTIVE INGREDIENT	7SEV7J4R1U	CLARINEX (DESLORATADINE) TABLET, FILM COATED CLARINEX (DESLORATADINE) SOLUTION [MERCK SHARP & DOHME CORP.]	14
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	CLARINEX (DESLORATADINE) TABLET, FILM COATED CLARINEX (DESLORATADINE) SOLUTION [MERCK SHARP & DOHME CORP.]	14
trisodium citrate dihydrate	INACTIVE INGREDIENT	B22547B95K	CLARINEX (DESLORATADINE) TABLET, FILM COATED CLARINEX (DESLORATADINE) SOLUTION [MERCK SHARP & DOHME CORP.]	14
water	INACTIVE INGREDIENT	059QF0KO0R	CLARINEX (DESLORATADINE) TABLET, FILM COATED CLARINEX (DESLORATADINE) SOLUTION [MERCK SHARP & DOHME CORP.]	14
white wax	INACTIVE INGREDIENT	7G1J5DA97F	CLARINEX (DESLORATADINE) TABLET, FILM COATED CLARINEX (DESLORATADINE) SOLUTION [MERCK SHARP & DOHME CORP.]	14
Desloratadine	ACTIVE INGREDIENT	FVF865388R	CLARINEX (DESLORATADINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
DESLORATADINE	ACTIVE INGREDIENT	FVF865388R	CLARINEX (DESLORATIDINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
Desloratadine	ACTIVE MOIETY	FVF865388R	CLARINEX (DESLORATADINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
DESLORATADINE	ACTIVE MOIETY	FVF865388R	CLARINEX (DESLORATIDINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	CLARINEX (DESLORATADINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	CLARINEX (DESLORATIDINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CLARINEX (DESLORATADINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CLARINEX (DESLORATIDINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
dibasic calcium phosphate dihydrate	INACTIVE INGREDIENT	O7TSZ97GEP	CLARINEX (DESLORATADINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	CLARINEX (DESLORATIDINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CLARINEX (DESLORATIDINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CLARINEX (DESLORATADINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CLARINEX (DESLORATADINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CLARINEX (DESLORATIDINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CLARINEX (DESLORATIDINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	CLARINEX (DESLORATADINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
polyethylene glycol	INACTIVE INGREDIENT	3WJQ0SDW1A	CLARINEX (DESLORATADINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	CLARINEX (DESLORATIDINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CLARINEX (DESLORATADINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CLARINEX (DESLORATIDINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CLARINEX (DESLORATIDINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	CLARINEX (DESLORATADINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CLARINEX (DESLORATIDINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	CLARINEX (DESLORATADINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
WHITE WAX	INACTIVE INGREDIENT	7G1J5DA97F	CLARINEX (DESLORATIDINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
WHITE WAX	INACTIVE INGREDIENT	7G1J5DA97F	CLARINEX (DESLORATADINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	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	DESLORATADINE	Organon LLC	c671342e-69a2-4ca5-abc2-8166ed4240d4	2025-05-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021165 application number: NDA021165

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
FVF865388R	DESLORATADINE	100643-71-8	DESLORATADINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
352086	CLARINEX 5 MG Oral Tablet	PSN	a7b5d043-da63-499c-b8bd-adf9295a6975	7
349420	desloratadine 5 MG Oral Tablet	PSN	a7b5d043-da63-499c-b8bd-adf9295a6975	7
352086	desloratadine 5 MG Oral Tablet [Clarinex]	SBD	a7b5d043-da63-499c-b8bd-adf9295a6975	7
349420	desloratadine 5 MG Oral Tablet	SCD	a7b5d043-da63-499c-b8bd-adf9295a6975	7
352086	Clarinex 5 MG Oral Tablet	SY	a7b5d043-da63-499c-b8bd-adf9295a6975	7
352086	CLARINEX 5 MG Oral Tablet	PSN	4b546121-ef6b-458c-ae0c-ce5bba3dc9a3	1
352086	CLARINEX 5 MG Oral Tablet	PSN	b7b0b1a0-2ab3-4697-bee4-0cd7fd5088b9	1
349420	desloratadine 5 MG Oral Tablet	PSN	4b546121-ef6b-458c-ae0c-ce5bba3dc9a3	1
349420	desloratadine 5 MG Oral Tablet	PSN	b7b0b1a0-2ab3-4697-bee4-0cd7fd5088b9	1
352086	desloratadine 5 MG Oral Tablet [Clarinex]	SBD	4b546121-ef6b-458c-ae0c-ce5bba3dc9a3	1
352086	desloratadine 5 MG Oral Tablet [Clarinex]	SBD	b7b0b1a0-2ab3-4697-bee4-0cd7fd5088b9	1
349420	desloratadine 5 MG Oral Tablet	SCD	4b546121-ef6b-458c-ae0c-ce5bba3dc9a3	1
349420	desloratadine 5 MG Oral Tablet	SCD	b7b0b1a0-2ab3-4697-bee4-0cd7fd5088b9	1
352086	Clarinex 5 MG Oral Tablet	SY	4b546121-ef6b-458c-ae0c-ce5bba3dc9a3	1
352086	Clarinex 5 MG Oral Tablet	SY	b7b0b1a0-2ab3-4697-bee4-0cd7fd5088b9	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0085-1264-01	00085126401	100 TABLET, FILM COATED in 1 BOTTLE (0085-1264-01)	2001-12-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clarinex	A-S Medication Solutions	2021-02-16	HUMAN PRESCRIPTION DRUG LABEL	7
Clarinex	Merck Sharp & Dohme Corp.	2021-01-27	HUMAN PRESCRIPTION DRUG LABEL	23
Clarinex - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2010-12-14	HUMAN PRESCRIPTION DRUG LABEL	1
CLARINEX ® (desloratadine) ® TABLETS	Rebel Distributors Corp	2010-09-23	HUMAN PRESCRIPTION DRUG LABEL	1