Home NDC 69282-002 Nioxin Hair Regrowth Treatment Extra Strength for Men
Product NDC 69282-002
11-digit product format 692820002
Labeler code 69282
Product ID 69282-002_ef5957f9-d8c8-4373-e053-2995a90a0793
Type HUMAN OTC DRUG
Nonproprietary name Minoxidil
Dosage form SOLUTION
Route TOPICAL
Labeler The Wella Corporation
Application ANDA075598
Marketing category ANDA
Marketing start 2014-11-01
Marketing end 0000-00-00
Substance MINOXIDIL
Active strength 5 g/100mL
Pharmacologic classes Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 33 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 69282-002-18 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 69282-002-60 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 69282-002-18 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 69282-002-60 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 69282-002-18 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 69282-002-60 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 69282-002-18 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 69282-002-60 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 69282-002-18 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 69282-002-60 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 69282-002-18 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 69282-002-60 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 69282-002-18 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 69282-002-60 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 69282-002-18 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 69282-002-60 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 69282-002-18 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 69282-002-60 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 69282-002-18 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 69282-002-60 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 69282-002-18 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 69282-002-60 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
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 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) MINOXIDIL 5% SOLUTION / TOPICAL 2001-06-13
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 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 cb3db0bc1861…
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# 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 · 20 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 69282-002-18 69282000218 3 BOTTLE, DROPPER in 1 CARTON (69282-002-18) > 60 mL in 1 BOTTLE, DROPPER 2014-11-01 0000-00-00 No No Current 69282-002-60 69282000260 1 BOTTLE, DROPPER in 1 CARTON (69282-002-60) > 60 mL in 1 BOTTLE, DROPPER 2014-11-01 0000-00-00 No No Current