Clarinex

Product NDC
0085-1264
Requested package NDC
0085-1264-01
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0085-12640085-1264-01DDiscontinued by firm2026-08-17

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021165-001CLARINEXDESLORATADINE5MGTABLET / ORALABRLD, RS2001-12-21

Therapeutic equivalence codes#

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

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

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N021165-001CLARINEX5MGTABLET / ORALABRLD, RS2001-12-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021165-001CLARINEX5MGTABLET / ORALABRLD, RS2001-12-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021165-001CLARINEX5MGTABLET / ORALABRLD, RS2001-12-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021165-001CLARINEX5MGTABLET / ORALABRLD, RS2001-12-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021165-001CLARINEX5MGTABLET / ORALABRLD, RS2001-12-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021165-001CLARINEX5MGTABLET / ORALABRLD, RS2001-12-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021165-001CLARINEX5MGTABLET / ORALABRLD, RS2001-12-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021165-001CLARINEX5MGTABLET / ORALABRLD, RS2001-12-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021165-001CLARINEX5MGTABLET / ORALABRLD, RS2001-12-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021165-001CLARINEX5MGTABLET / ORALABRLD, RS2001-12-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021165-001CLARINEX5MGTABLET / ORALABRLD, RS2001-12-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021165-001CLARINEX5MGTABLET / ORALABRLD, RS2001-12-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021165-001CLARINEX5MGTABLET / ORALABRLD, RS2001-12-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021165-001CLARINEX5MGTABLET / ORALABRLD, RS2001-12-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021165-001CLARINEX5MGTABLET / ORALABRLD, RS2001-12-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021165-001CLARINEX5MGTABLET / ORALABRLD, RS2001-12-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021165-001CLARINEX5MGTABLET / ORALABRLD, RS2001-12-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021165-001CLARINEX5MGTABLET / ORALABRLD, RS2001-12-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021165-001CLARINEX5MGTABLET / ORALABRLD, RS2001-12-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021165-001CLARINEX5MGTABLET / ORALABRLD, RS2001-12-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021165-001CLARINEX5MGTABLET / ORALABRLD, RS2001-12-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021165-001CLARINEX5MGTABLET / ORALABRLD, RS2001-12-2187673890dc5c…
2021-03-12 10:30 UTC2021-03N021165-001CLARINEX5MGTABLET / ORALABRLD, RS2001-12-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021165-001CLARINEX5MGTABLET / ORALABRLD, RS2001-12-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021165-001CLARINEX5MGTABLET / ORALABRLD, RS2001-12-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021165-001CLARINEX5MGTABLET / ORALABRLD, RS2001-12-213f01610625f2…
2019-09-15 20:21 UTC2019-09N021165-001CLARINEX5MGTABLET / ORALABRLD, RS2001-12-21b00525d2431f…
2019-07-19 19:46 UTC2019-07N021165-001CLARINEX5MGTABLET / ORALABRLD, RS2001-12-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021165-001CLARINEX5MGTABLET / ORALABRLD, RS2001-12-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021165-001CLARINEX5MGTABLET / ORALABRLD, RS2001-12-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021165-001CLARINEX5MGTABLET / ORALABRLD, RS2001-12-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021165-001CLARINEX5MGTABLET / ORALABRLD, RS2001-12-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021165-001CLARINEX5MGTABLET / ORALABRLD, RS2001-12-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021165-001CLARINEX5MGTABLET / ORALABRLD, RS2001-12-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021165-001CLARINEX5MGTABLET / ORALABRLD, RS2001-12-213f0d92c62455…
2023-05-13 08:27 UTC2023-05N021165-001CLARINEX5MGTABLET / ORALABRLD, RS2001-12-21053a50430f4f…
2023-01-26 05:58 UTC2023-01N021165-001CLARINEX5MGTABLET / ORALABRLD, RS2001-12-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021165-001CLARINEX5MGTABLET / ORALABRLD, RS2001-12-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021165-001CLARINEX5MGTABLET / ORALABRLD, RS2001-12-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021165-001CLARINEX5MGTABLET / ORALABRLD, RS2001-12-21e64feba35796…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N021165-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021165-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021165-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021165-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021165-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021165-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021165-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021165-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021165-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021165-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021165-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021165-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021165-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021165-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021165-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021165-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021165-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021165-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021165-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021165-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021165-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021165-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N021165-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021165-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021165-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021165-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N021165-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N021165-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021165-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021165-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021165-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021165-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021165-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021165-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021165-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N021165-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N021165-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021165-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021165-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021165-001AB1e64feba35796…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021165-00161002742019-07-0774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021165-00174052232019-07-07U-88674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021165-0016100274*PED2020-01-07Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021165-0017405223*PED2020-01-07Pediatric extension74a2ff9319b5…
2020-12-22 03:56 UTC2020-12N021165-0016100274*PED2020-01-07Pediatric extension8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021165-0017405223*PED2020-01-07Pediatric extension8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021165-0016100274*PED2020-01-07Pediatric extensionc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021165-0017405223*PED2020-01-07Pediatric extensionc0c555d07b60…
2019-12-14 00:12 UTC2019-12N021165-00161002742019-07-073f01610625f2…
2019-12-14 00:12 UTC2019-12N021165-00174052232019-07-07U-8863f01610625f2…
2019-12-14 00:12 UTC2019-12N021165-0016100274*PED2020-01-07Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N021165-0017405223*PED2020-01-07Pediatric extension3f01610625f2…
2019-09-15 20:21 UTC2019-09N021165-00161002742019-07-07b00525d2431f…
2019-09-15 20:21 UTC2019-09N021165-00174052232019-07-07U-886b00525d2431f…
2019-09-15 20:21 UTC2019-09N021165-0016100274*PED2020-01-07Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N021165-0017405223*PED2020-01-07Pediatric extensionb00525d2431f…
2019-07-19 19:46 UTC2019-07N021165-00161002742019-07-07ea99ee380514…
2019-07-19 19:46 UTC2019-07N021165-00174052232019-07-07U-886ea99ee380514…
2019-07-19 19:46 UTC2019-07N021165-0016100274*PED2020-01-07Pediatric extensionea99ee380514…
2019-07-19 19:46 UTC2019-07N021165-0017405223*PED2020-01-07Pediatric extensionea99ee380514…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
01632a31-f1c5-44ea-aa59-efded68c0797Product name120150716
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
c6d3c427-3d3d-6bcf-7aa8-536d42cf1fd8Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0085-1264-01EA - Each0085-1264a52a2601-c79a-434d-bde1-5c09cea2a47112012-07-24
0085-1264-02EA - Each0085-126445468c58-f299-4135-83ef-18e6ba926b4b12012-07-24
0085-1264-03EA - Each0085-126430cfda1d-549b-438e-8225-2ce37a77850912012-07-24
0085-1264-04EA - Each0085-126406a454bb-7e67-4dd6-9099-6cb655adc72012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DesloratadineACTIVE INGREDIENTFVF865388RCLARINEX (DESLORATADINE) TABLET, FILM COATED CLARINEX (DESLORATADINE) SOLUTION [MERCK SHARP & DOHME CORP.]14
DesloratadineACTIVE MOIETYFVF865388RCLARINEX (DESLORATADINE) TABLET, FILM COATED CLARINEX (DESLORATADINE) SOLUTION [MERCK SHARP & DOHME CORP.]14
Aluminum OxideINACTIVE INGREDIENTLMI26O6933CLARINEX (DESLORATADINE) TABLET, FILM COATED CLARINEX (DESLORATADINE) SOLUTION [MERCK SHARP & DOHME CORP.]14
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLCLARINEX (DESLORATADINE) TABLET, FILM COATED CLARINEX (DESLORATADINE) SOLUTION [MERCK SHARP & DOHME CORP.]14
calcium phosphate, dibasic, dihydrateINACTIVE INGREDIENTO7TSZ97GEPCLARINEX (DESLORATADINE) TABLET, FILM COATED CLARINEX (DESLORATADINE) SOLUTION [MERCK SHARP & DOHME CORP.]14
carnauba waxINACTIVE INGREDIENTR12CBM0EIZCLARINEX (DESLORATADINE) TABLET, FILM COATED CLARINEX (DESLORATADINE) SOLUTION [MERCK SHARP & DOHME CORP.]14
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UCLARINEX (DESLORATADINE) TABLET, FILM COATED CLARINEX (DESLORATADINE) SOLUTION [MERCK SHARP & DOHME CORP.]14
edetate disodiumINACTIVE INGREDIENT7FLD91C86KCLARINEX (DESLORATADINE) TABLET, FILM COATED CLARINEX (DESLORATADINE) SOLUTION [MERCK SHARP & DOHME CORP.]14
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKCLARINEX (DESLORATADINE) TABLET, FILM COATED CLARINEX (DESLORATADINE) SOLUTION [MERCK SHARP & DOHME CORP.]14
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8CLARINEX (DESLORATADINE) TABLET, FILM COATED CLARINEX (DESLORATADINE) SOLUTION [MERCK SHARP & DOHME CORP.]14
hypromellosesINACTIVE INGREDIENT3NXW29V3WOCLARINEX (DESLORATADINE) TABLET, FILM COATED CLARINEX (DESLORATADINE) SOLUTION [MERCK SHARP & DOHME CORP.]14
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XCLARINEX (DESLORATADINE) TABLET, FILM COATED CLARINEX (DESLORATADINE) SOLUTION [MERCK SHARP & DOHME CORP.]14
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ACLARINEX (DESLORATADINE) TABLET, FILM COATED CLARINEX (DESLORATADINE) SOLUTION [MERCK SHARP & DOHME CORP.]14
propylene glycolINACTIVE INGREDIENT6DC9Q167V3CLARINEX (DESLORATADINE) TABLET, FILM COATED CLARINEX (DESLORATADINE) SOLUTION [MERCK SHARP & DOHME CORP.]14
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUCLARINEX (DESLORATADINE) TABLET, FILM COATED CLARINEX (DESLORATADINE) SOLUTION [MERCK SHARP & DOHME CORP.]14
sorbitolINACTIVE INGREDIENT506T60A25RCLARINEX (DESLORATADINE) TABLET, FILM COATED CLARINEX (DESLORATADINE) SOLUTION [MERCK SHARP & DOHME CORP.]14
starch, cornINACTIVE INGREDIENTO8232NY3SJCLARINEX (DESLORATADINE) TABLET, FILM COATED CLARINEX (DESLORATADINE) SOLUTION [MERCK SHARP & DOHME CORP.]14
talcINACTIVE INGREDIENT7SEV7J4R1UCLARINEX (DESLORATADINE) TABLET, FILM COATED CLARINEX (DESLORATADINE) SOLUTION [MERCK SHARP & DOHME CORP.]14
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCLARINEX (DESLORATADINE) TABLET, FILM COATED CLARINEX (DESLORATADINE) SOLUTION [MERCK SHARP & DOHME CORP.]14
trisodium citrate dihydrateINACTIVE INGREDIENTB22547B95KCLARINEX (DESLORATADINE) TABLET, FILM COATED CLARINEX (DESLORATADINE) SOLUTION [MERCK SHARP & DOHME CORP.]14
waterINACTIVE INGREDIENT059QF0KO0RCLARINEX (DESLORATADINE) TABLET, FILM COATED CLARINEX (DESLORATADINE) SOLUTION [MERCK SHARP & DOHME CORP.]14
white waxINACTIVE INGREDIENT7G1J5DA97FCLARINEX (DESLORATADINE) TABLET, FILM COATED CLARINEX (DESLORATADINE) SOLUTION [MERCK SHARP & DOHME CORP.]14
DesloratadineACTIVE INGREDIENTFVF865388RCLARINEX (DESLORATADINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
DESLORATADINEACTIVE INGREDIENTFVF865388RCLARINEX (DESLORATIDINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
DesloratadineACTIVE MOIETYFVF865388RCLARINEX (DESLORATADINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
DESLORATADINEACTIVE MOIETYFVF865388RCLARINEX (DESLORATIDINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZCLARINEX (DESLORATADINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZCLARINEX (DESLORATIDINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLARINEX (DESLORATADINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLARINEX (DESLORATIDINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
dibasic calcium phosphate dihydrateINACTIVE INGREDIENTO7TSZ97GEPCLARINEX (DESLORATADINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPCLARINEX (DESLORATIDINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCLARINEX (DESLORATIDINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCLARINEX (DESLORATADINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCLARINEX (DESLORATADINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCLARINEX (DESLORATIDINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLARINEX (DESLORATIDINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XCLARINEX (DESLORATADINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
polyethylene glycolINACTIVE INGREDIENT3WJQ0SDW1ACLARINEX (DESLORATADINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ACLARINEX (DESLORATIDINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLARINEX (DESLORATADINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLARINEX (DESLORATIDINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCLARINEX (DESLORATIDINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
talcINACTIVE INGREDIENT7SEV7J4R1UCLARINEX (DESLORATADINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLARINEX (DESLORATIDINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCLARINEX (DESLORATADINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FCLARINEX (DESLORATIDINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FCLARINEX (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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClarinexDESLORATADINEOrganon LLCc671342e-69a2-4ca5-abc2-8166ed4240d42025-05-17Warnings, Adverse reactionsExact identifier
application applno (NDA): 021165
application number: NDA021165

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
352086CLARINEX 5 MG Oral TabletPSNa7b5d043-da63-499c-b8bd-adf9295a69757
349420desloratadine 5 MG Oral TabletPSNa7b5d043-da63-499c-b8bd-adf9295a69757
352086desloratadine 5 MG Oral Tablet [Clarinex]SBDa7b5d043-da63-499c-b8bd-adf9295a69757
349420desloratadine 5 MG Oral TabletSCDa7b5d043-da63-499c-b8bd-adf9295a69757
352086Clarinex 5 MG Oral TabletSYa7b5d043-da63-499c-b8bd-adf9295a69757
352086CLARINEX 5 MG Oral TabletPSN4b546121-ef6b-458c-ae0c-ce5bba3dc9a31
352086CLARINEX 5 MG Oral TabletPSNb7b0b1a0-2ab3-4697-bee4-0cd7fd5088b91
349420desloratadine 5 MG Oral TabletPSN4b546121-ef6b-458c-ae0c-ce5bba3dc9a31
349420desloratadine 5 MG Oral TabletPSNb7b0b1a0-2ab3-4697-bee4-0cd7fd5088b91
352086desloratadine 5 MG Oral Tablet [Clarinex]SBD4b546121-ef6b-458c-ae0c-ce5bba3dc9a31
352086desloratadine 5 MG Oral Tablet [Clarinex]SBDb7b0b1a0-2ab3-4697-bee4-0cd7fd5088b91
349420desloratadine 5 MG Oral TabletSCD4b546121-ef6b-458c-ae0c-ce5bba3dc9a31
349420desloratadine 5 MG Oral TabletSCDb7b0b1a0-2ab3-4697-bee4-0cd7fd5088b91
352086Clarinex 5 MG Oral TabletSY4b546121-ef6b-458c-ae0c-ce5bba3dc9a31
352086Clarinex 5 MG Oral TabletSYb7b0b1a0-2ab3-4697-bee4-0cd7fd5088b91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0085-1264-0100085126401100 TABLET, FILM COATED in 1 BOTTLE (0085-1264-01) 2001-12-210000-00-00NoNoCurrent