Home NDC 69489-212 ZILXI
Product NDC 69489-212
11-digit product format 694890212
Labeler code 69489
Product ID 69489-212_e5d4b4fa-1951-4fa8-9677-acb97b10c087
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Minocycline
Dosage form AEROSOL, FOAM
Route TOPICAL
Labeler Journey Medical Corporation
Application NDA213690
Marketing category NDA
Marketing start 2022-10-01
Substance MINOCYCLINE HYDROCHLORIDE
Active strength 15 mg/g
Pharmacologic classes Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 N213690-001 ZILXI MINOCYCLINE HYDROCHLORIDE EQ 1.5% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2020-05-28
Orange Book patents# Current patent rows page 1 of 1 · 9 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213690-001 10213512 2030-10-01 U-1631 Drug product 2020-06-22 N213690-001 10265404 2030-10-01 Drug product 2020-06-22 N213690-001 10322186 2030-10-01 U-1631 2020-06-22 N213690-001 10946101 2030-10-01 U-1631 2021-03-22 N213690-001 12138311 2030-10-01 U-1631 2024-12-11 N213690-001 8865139 2030-10-01 U-1631 Drug product 2020-06-22 N213690-001 8945516 2030-10-01 Drug product 2020-06-22 N213690-001 8992896 2030-10-01 U-1631 Drug product 2020-06-22 N213690-001 9675700 2030-10-01 U-1631 Drug product 2020-06-22
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.
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 N213690-001 ZILXI EQ 1.5% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2020-05-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213690-001 ZILXI EQ 1.5% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2020-05-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213690-001 ZILXI EQ 1.5% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2020-05-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213690-001 ZILXI EQ 1.5% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2020-05-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213690-001 ZILXI EQ 1.5% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2020-05-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213690-001 ZILXI EQ 1.5% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2020-05-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213690-001 ZILXI EQ 1.5% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2020-05-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213690-001 ZILXI EQ 1.5% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2020-05-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213690-001 ZILXI EQ 1.5% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2020-05-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213690-001 ZILXI EQ 1.5% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2020-05-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213690-001 ZILXI EQ 1.5% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2020-05-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213690-001 ZILXI EQ 1.5% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2020-05-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213690-001 ZILXI EQ 1.5% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2020-05-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213690-001 ZILXI EQ 1.5% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2020-05-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213690-001 ZILXI EQ 1.5% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2020-05-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213690-001 ZILXI EQ 1.5% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2020-05-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213690-001 ZILXI EQ 1.5% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2020-05-28 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213690-001 ZILXI EQ 1.5% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2020-05-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213690-001 ZILXI EQ 1.5% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2020-05-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213690-001 ZILXI EQ 1.5% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2020-05-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N213690-001 ZILXI EQ 1.5% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2020-05-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N213690-001 ZILXI EQ 1.5% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2020-05-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N213690-001 ZILXI EQ 1.5% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2020-05-28 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213690-001 ZILXI EQ 1.5% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2020-05-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N213690-001 ZILXI EQ 1.5% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2020-05-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N213690-001 ZILXI EQ 1.5% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2020-05-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N213690-001 ZILXI EQ 1.5% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2020-05-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N213690-001 ZILXI EQ 1.5% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2020-05-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N213690-001 ZILXI EQ 1.5% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2020-05-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N213690-001 ZILXI EQ 1.5% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2020-05-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N213690-001 ZILXI EQ 1.5% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2020-05-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N213690-001 ZILXI EQ 1.5% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2020-05-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N213690-001 ZILXI EQ 1.5% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2020-05-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N213690-001 ZILXI EQ 1.5% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2020-05-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N213690-001 ZILXI EQ 1.5% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2020-05-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N213690-001 ZILXI EQ 1.5% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2020-05-28 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213690-001 ZILXI EQ 1.5% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2020-05-28 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 8 · 301 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N213690-001 10213512 2030-10-01 U-1631 Drug product 2020-06-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213690-001 10265404 2030-10-01 Drug product 2020-06-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213690-001 10322186 2030-10-01 U-1631 2020-06-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213690-001 10946101 2030-10-01 U-1631 2021-03-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213690-001 12138311 2030-10-01 U-1631 2024-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213690-001 8865139 2030-10-01 U-1631 Drug product 2020-06-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213690-001 8945516 2030-10-01 Drug product 2020-06-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213690-001 8992896 2030-10-01 U-1631 Drug product 2020-06-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213690-001 9675700 2030-10-01 U-1631 Drug product 2020-06-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213690-001 10213512 2030-10-01 U-1631 Drug product 2020-06-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213690-001 10265404 2030-10-01 Drug product 2020-06-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213690-001 10322186 2030-10-01 U-1631 2020-06-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213690-001 10946101 2030-10-01 U-1631 2021-03-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213690-001 12138311 2030-10-01 U-1631 2024-12-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213690-001 8865139 2030-10-01 U-1631 Drug product 2020-06-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213690-001 8945516 2030-10-01 Drug product 2020-06-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213690-001 8992896 2030-10-01 U-1631 Drug product 2020-06-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213690-001 9675700 2030-10-01 U-1631 Drug product 2020-06-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213690-001 10213512 2030-10-01 U-1631 Drug product 2020-06-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213690-001 10265404 2030-10-01 Drug product 2020-06-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213690-001 10322186 2030-10-01 U-1631 2020-06-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213690-001 10946101 2030-10-01 U-1631 2021-03-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213690-001 12138311 2030-10-01 U-1631 2024-12-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213690-001 8865139 2030-10-01 U-1631 Drug product 2020-06-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213690-001 8945516 2030-10-01 Drug product 2020-06-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213690-001 8992896 2030-10-01 U-1631 Drug product 2020-06-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213690-001 9675700 2030-10-01 U-1631 Drug product 2020-06-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213690-001 10213512 2030-10-01 U-1631 Drug product 2020-06-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213690-001 10265404 2030-10-01 Drug product 2020-06-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213690-001 10322186 2030-10-01 U-1631 2020-06-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213690-001 10946101 2030-10-01 U-1631 2021-03-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213690-001 12138311 2030-10-01 U-1631 2024-12-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213690-001 8865139 2030-10-01 U-1631 Drug product 2020-06-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213690-001 8945516 2030-10-01 Drug product 2020-06-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213690-001 8992896 2030-10-01 U-1631 Drug product 2020-06-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213690-001 9675700 2030-10-01 U-1631 Drug product 2020-06-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213690-001 10213512 2030-10-01 U-1631 Drug product 2020-06-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213690-001 10265404 2030-10-01 Drug product 2020-06-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213690-001 10322186 2030-10-01 U-1631 2020-06-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213690-001 10946101 2030-10-01 U-1631 2021-03-22 b8a1b40f171c…
Additional Listing Data#
Finished product Yes
Brand name base ZILXI
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MINOCYCLINE HYDROCHLORIDE 15 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0020414E5U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2375333 Internal RxNorm lookup 2375338 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69489-212 ZILXI (MINOCYCLINE) AEROSOL, FOAM [JOURNEY MEDICAL CORPORATION] 3 Current NDC, Legacy NDC, 6 package rows 20240210_cbffa96e-2446-43cf-ba5e-38c645302afd.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ZILXI MINOCYCLINE Journey Medical Corporation cbffa96e-2446-43cf-ba5e-38c645302afd 2024-02-09 Warnings, Adverse reactions Exact identifier application applno (NDA): 213690 application number: NDA213690 ndc (product): 69489-212
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 69489-212-03 69489021203 1 CAN in 1 CARTON (69489-212-03) / 3 g in 1 CAN 1 can 2023-11-01 Yes No Current 69489-212-07 69489021207 1 CAN in 1 CARTON (69489-212-07) > 7 g in 1 CAN 1 can 2022-10-01 0000-00-00 Yes No Current 69489-212-30 69489021230 1 CAN in 1 CARTON (69489-212-30) / 30 g in 1 CAN 1 can 2023-06-01 No No Current