Home NDC 68391-294 berkley and jensen minoxidil
Product NDC 68391-294
11-digit product format 683910294
Labeler code 68391
Product ID 68391-294_7945de8e-6c67-4dfb-9711-630a84a04871
Type HUMAN OTC DRUG
Nonproprietary name Minoxidil
Dosage form AEROSOL, FOAM
Route TOPICAL
Labeler BJWC
Application ANDA091344
Marketing category ANDA
Marketing start 2018-11-01
Substance MINOXIDIL
Active strength 5 g/100g
Pharmacologic classes Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
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 43 .
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 · 43 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 2026-09-14 22:38:34 2026-08 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 84e616aacf4f…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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base berkley and jensen minoxidil
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MINOXIDIL 5 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5965120SH1 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 645146 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68391-294-04 berkley and jensen minoxidil 4 in 1 CARTON AEROSOL, FOAM 4 5 68391-294-04 berkley and jensen minoxidil 60 g in 1 CAN AEROSOL, FOAM 60 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68391-294 BERKLEY AND JENSEN MINOXIDIL (MINOXIDIL) AEROSOL, FOAM [BJWC] 5 Current NDC, Legacy NDC, 2 package rows 20250430_6cfa4553-1d0a-41eb-9059-83b8fac6ddd0.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 2 of 2 · 22 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 68391-294-04 68391029404 4 CAN in 1 CARTON (68391-294-04) / 60 g in 1 CAN 4 can 2018-11-01 0000-00-00 No No Current