Home NDC 63940-385 Core Values Minoxidil
Product NDC 63940-385
11-digit product format 639400385
Labeler code 63940
Product ID 63940-385_12146a69-9bc7-4d13-91d6-63fe1010a177
Type HUMAN OTC DRUG
Nonproprietary name Minoxidil
Dosage form AEROSOL, FOAM
Route TOPICAL
Labeler Harmon Stores Inc.
Application ANDA091344
Marketing category ANDA
Marketing start 2017-05-17
Marketing end 0000-00-00
Substance MINOXIDIL
Active strength 5 g/100g
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 63940-385-03 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 63940-385-03 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 63940-385-03 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 63940-385-03 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 63940-385-03 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 63940-385-03 cdf11ea48f46…ba0047e9e063…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A091344-001 MINOXIDIL MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28
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 · 42 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 2026-08-18 06:07:40 2026-07 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 e64feba35796…
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 2 · 21 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63940-385-03 63940038503 3 CAN in 1 CARTON (63940-385-03) > 60 g in 1 CAN 3 can 2017-05-17 0000-00-00 No No Current