Home NDC 0085-1334 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 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.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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date N021300-001 CLARINEX DESLORATADINE 0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2004-09-01
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 · 43 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 2026-09-14 22:38:34 2026-08 N021300-001 CLARINEX 0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2004-09-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021300-001 CLARINEX 0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2004-09-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021300-001 CLARINEX 0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2004-09-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021300-001 CLARINEX 0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2004-09-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021300-001 CLARINEX 0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2004-09-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021300-001 CLARINEX 0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2004-09-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021300-001 CLARINEX 0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2004-09-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021300-001 CLARINEX 0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2004-09-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021300-001 CLARINEX 0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2004-09-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021300-001 CLARINEX 0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2004-09-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021300-001 CLARINEX 0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2004-09-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021300-001 CLARINEX 0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2004-09-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021300-001 CLARINEX 0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2004-09-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021300-001 CLARINEX 0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2004-09-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021300-001 CLARINEX 0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2004-09-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021300-001 CLARINEX 0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2004-09-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021300-001 CLARINEX 0.5MG/ML SOLUTION / ORAL RLD 2004-09-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021300-001 CLARINEX 0.5MG/ML SOLUTION / ORAL RLD 2004-09-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021300-001 CLARINEX 0.5MG/ML SOLUTION / ORAL RLD 2004-09-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021300-001 CLARINEX 0.5MG/ML SOLUTION / ORAL AA RLD, RS 2004-09-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021300-001 CLARINEX 0.5MG/ML SOLUTION / ORAL RLD 2004-09-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021300-001 CLARINEX 0.5MG/ML SOLUTION / ORAL RLD 2004-09-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021300-001 CLARINEX 0.5MG/ML SOLUTION / ORAL RLD 2004-09-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021300-001 CLARINEX 0.5MG/ML SOLUTION / ORAL RLD 2004-09-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021300-001 CLARINEX 0.5MG/ML SOLUTION / ORAL AA RLD, RS 2004-09-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021300-001 CLARINEX 0.5MG/ML SOLUTION / ORAL AA RLD, RS 2004-09-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021300-001 CLARINEX 0.5MG/ML SOLUTION / ORAL AA RLD, RS 2004-09-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021300-001 CLARINEX 0.5MG/ML SOLUTION / ORAL AA RLD, RS 2004-09-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021300-001 CLARINEX 0.5MG/ML SOLUTION / ORAL AA RLD, RS 2004-09-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021300-001 CLARINEX 0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2004-09-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021300-001 CLARINEX 0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2004-09-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021300-001 CLARINEX 0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2004-09-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021300-001 CLARINEX 0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2004-09-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021300-001 CLARINEX 0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2004-09-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021300-001 CLARINEX 0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2004-09-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021300-001 CLARINEX 0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2004-09-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021300-001 CLARINEX 0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2004-09-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021300-001 CLARINEX 0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2004-09-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021300-001 CLARINEX 0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2004-09-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021300-001 CLARINEX 0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2004-09-01 f41ea6bd6efb…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded 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