Home NDC 69489-711 Exelderm
Product NDC 69489-711
11-digit product format 694890711
Labeler code 69489
Product ID 69489-711_f03361cb-005c-4d0c-bc27-033484f02624
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sulconazole Nitrate
Dosage form CREAM
Route TOPICAL
Labeler Journey Medical Corporation
Application NDA018737
Marketing category NDA
Marketing start 2019-06-07
Substance SULCONAZOLE NITRATE
Active strength 10 mg/g
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 N018737-001 EXELDERM SULCONAZOLE NITRATE 1% CREAM / TOPICAL RLD, RS 1989-02-28
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 Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N018737-001 EXELDERM 1% CREAM / TOPICAL RLD, RS 1989-02-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018737-001 EXELDERM 1% CREAM / TOPICAL RLD, RS 1989-02-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018737-001 EXELDERM 1% CREAM / TOPICAL RLD, RS 1989-02-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018737-001 EXELDERM 1% CREAM / TOPICAL RLD, RS 1989-02-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018737-001 EXELDERM 1% CREAM / TOPICAL RLD, RS 1989-02-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018737-001 EXELDERM 1% CREAM / TOPICAL RLD, RS 1989-02-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018737-001 EXELDERM 1% CREAM / TOPICAL RLD, RS 1989-02-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018737-001 EXELDERM 1% CREAM / TOPICAL RLD, RS 1989-02-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018737-001 EXELDERM 1% CREAM / TOPICAL RLD, RS 1989-02-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018737-001 EXELDERM 1% CREAM / TOPICAL RLD, RS 1989-02-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018737-001 EXELDERM 1% CREAM / TOPICAL RLD, RS 1989-02-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018737-001 EXELDERM 1% CREAM / TOPICAL RLD, RS 1989-02-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018737-001 EXELDERM 1% CREAM / TOPICAL RLD, RS 1989-02-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018737-001 EXELDERM 1% CREAM / TOPICAL RLD, RS 1989-02-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018737-001 EXELDERM 1% CREAM / TOPICAL RLD, RS 1989-02-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018737-001 EXELDERM 1% CREAM / TOPICAL RLD, RS 1989-02-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018737-001 EXELDERM 1% CREAM / TOPICAL RLD, RS 1989-02-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018737-001 EXELDERM 1% CREAM / TOPICAL RLD, RS 1989-02-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018737-001 EXELDERM 1% CREAM / TOPICAL RLD, RS 1989-02-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N018737-001 EXELDERM 1% CREAM / TOPICAL RLD, RS 1989-02-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N018737-001 EXELDERM 1% CREAM / TOPICAL RLD, RS 1989-02-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N018737-001 EXELDERM 1% CREAM / TOPICAL RLD, RS 1989-02-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N018737-001 EXELDERM 1% CREAM / TOPICAL RLD, RS 1989-02-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N018737-001 EXELDERM 1% CREAM / TOPICAL RLD, RS 1989-02-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N018737-001 EXELDERM 1% CREAM / TOPICAL RLD, RS 1989-02-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N018737-001 EXELDERM 1% CREAM / TOPICAL RLD, RS 1989-02-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N018737-001 EXELDERM 1% CREAM / TOPICAL RLD, RS 1989-02-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N018737-001 EXELDERM 1% CREAM / TOPICAL RLD, RS 1989-02-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N018737-001 EXELDERM 1% CREAM / TOPICAL RLD, RS 1989-02-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N018737-001 EXELDERM 1% CREAM / TOPICAL RLD, RS 1989-02-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N018737-001 EXELDERM 1% CREAM / TOPICAL RLD, RS 1989-02-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N018737-001 EXELDERM 1% CREAM / TOPICAL RLD, RS 1989-02-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N018737-001 EXELDERM 1% CREAM / TOPICAL RLD, RS 1989-02-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N018737-001 EXELDERM 1% CREAM / TOPICAL RLD, RS 1989-02-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N018737-001 EXELDERM 1% CREAM / TOPICAL RLD, RS 1989-02-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N018737-001 EXELDERM 1% CREAM / TOPICAL RLD, RS 1989-02-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N018737-001 EXELDERM 1% CREAM / TOPICAL RLD, RS 1989-02-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N018737-001 EXELDERM 1% CREAM / TOPICAL RLD, RS 1989-02-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N018737-001 EXELDERM 1% CREAM / TOPICAL RLD, RS 1989-02-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N018737-001 EXELDERM 1% CREAM / TOPICAL RLD, RS 1989-02-28 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Exelderm
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SULCONAZOLE NITRATE 10 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1T89100D5U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 106366 Internal RxNorm lookup 208117 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69489-711-60 Exelderm 60 g in 1 TUBE CREAM 60 2 69489-711-60 Exelderm 1 in 1 CARTON CREAM 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69489-711 EXELDERM (SULCONAZOLE NITRATE) CREAM [JOURNEY MEDICAL CORPORATION] 2 Current NDC, Legacy NDC, 2 package rows 20220721_1d822e06-f37e-4984-8365-efd4c4451478.zip
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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69489-711-60 69489071160 1 TUBE in 1 CARTON (69489-711-60) / 60 g in 1 TUBE 1 tube 2019-06-07 0000-00-00 No No Current