Clarinex

Product NDC
0085-1334
11-digit product format
000851334
Labeler code
0085
Product ID
0085-1334_22ffac95-2fe0-47f7-96c4-1d16f396cb5e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desloratadine
Dosage form
SOLUTION
Route
ORAL
Labeler
Merck Sharp & Dohme Corp.
Application
NDA021300
Marketing category
NDA
Marketing start
2004-09-01
Marketing end
0000-00-00
Substance
DESLORATADINE
Active strength
1 mg/mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0085-1334DDiscontinued by firm2026-08-17
excluded packagepackage0085-13340085-1334-01DDiscontinued by firm2026-08-17
excluded packagepackage0085-13340085-1334-02DDiscontinued 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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0085-1334-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0085-1334-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0085-1334-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0085-1334-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0085-1334-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0085-1334-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0085-1334-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0085-1334-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0085-1334-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0085-1334-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0085-1334-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0085-1334-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0085-1334-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0085-1334-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0085-1334-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0085-1334-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0085-1334-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0085-1334-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0085-1334-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0085-1334-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0085-1334-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0085-1334-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0085-1334-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0085-1334-02557ba5c1ecfa…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
N021300-001CLARINEXDESLORATADINE0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2004-09-01

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N021300-001CLARINEX0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2004-09-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021300-001CLARINEX0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2004-09-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021300-001CLARINEX0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2004-09-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021300-001CLARINEX0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2004-09-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021300-001CLARINEX0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2004-09-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021300-001CLARINEX0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2004-09-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021300-001CLARINEX0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2004-09-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021300-001CLARINEX0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2004-09-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021300-001CLARINEX0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2004-09-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021300-001CLARINEX0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2004-09-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021300-001CLARINEX0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2004-09-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021300-001CLARINEX0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2004-09-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021300-001CLARINEX0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2004-09-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021300-001CLARINEX0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2004-09-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021300-001CLARINEX0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2004-09-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021300-001CLARINEX0.5MG/MLSOLUTION / ORALRLD2004-09-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021300-001CLARINEX0.5MG/MLSOLUTION / ORALRLD2004-09-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021300-001CLARINEX0.5MG/MLSOLUTION / ORALRLD2004-09-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021300-001CLARINEX0.5MG/MLSOLUTION / ORALAARLD, RS2004-09-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021300-001CLARINEX0.5MG/MLSOLUTION / ORALRLD2004-09-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021300-001CLARINEX0.5MG/MLSOLUTION / ORALRLD2004-09-01782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021300-001CLARINEX0.5MG/MLSOLUTION / ORALRLD2004-09-0187673890dc5c…
2021-03-12 10:30 UTC2021-03N021300-001CLARINEX0.5MG/MLSOLUTION / ORALRLD2004-09-015aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021300-001CLARINEX0.5MG/MLSOLUTION / ORALAARLD, RS2004-09-018869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021300-001CLARINEX0.5MG/MLSOLUTION / ORALAARLD, RS2004-09-01c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021300-001CLARINEX0.5MG/MLSOLUTION / ORALAARLD, RS2004-09-013f01610625f2…
2019-09-15 20:21 UTC2019-09N021300-001CLARINEX0.5MG/MLSOLUTION / ORALAARLD, RS2004-09-01b00525d2431f…
2019-07-19 19:46 UTC2019-07N021300-001CLARINEX0.5MG/MLSOLUTION / ORALAARLD, RS2004-09-01ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021300-001CLARINEX0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2004-09-016a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021300-001CLARINEX0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2004-09-011c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021300-001CLARINEX0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2004-09-01ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021300-001CLARINEX0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2004-09-01a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021300-001CLARINEX0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2004-09-019b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021300-001CLARINEX0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2004-09-01a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021300-001CLARINEX0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2004-09-013f0d92c62455…
2023-05-13 08:27 UTC2023-05N021300-001CLARINEX0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2004-09-01053a50430f4f…
2023-01-26 05:58 UTC2023-01N021300-001CLARINEX0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2004-09-013bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021300-001CLARINEX0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2004-09-013a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021300-001CLARINEX0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2004-09-01f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021300-001CLARINEX0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2004-09-01e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12N021300-001AA174a2ff9319b5…
2020-12-22 03:56 UTC2020-12N021300-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021300-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021300-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09N021300-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07N021300-001AA1ea99ee380514…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0085-1334-01ML - Milliliter0085-1334af790547-4604-4d0b-8e35-aaa612a1806712012-07-24

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