Home NDC 68391-302 berkley and jensen minoxidil
Product NDC 68391-302
11-digit product format 683910302
Labeler code 68391
Product ID 68391-302_564e9005-27b3-4caa-ab1d-eaf4817b35c2
Type HUMAN OTC DRUG
Nonproprietary name minoxidil
Dosage form SOLUTION
Route TOPICAL
Labeler BJWC
Application ANDA075598
Marketing category ANDA
Marketing start 2022-07-23
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 2024-12-31
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 68391-302 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68391-302 68391-302-40 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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…
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68391-302 BERKLEY AND JENSEN MINOXIDIL (MINOXIDIL) SOLUTION [BJWC] 2 Legacy NDC 20230112_aae37a8a-52b2-4792-9b87-d350cd8516f2.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 · 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 68391-302-40 68391030240 6 BOTTLE, DROPPER in 1 CARTON (68391-302-40) > 60 mL in 1 BOTTLE, DROPPER 2022-07-23 0000-00-00 No No Current