Home NDC 0363-0032 hair regrowth treatment
Product NDC 0363-0032
11-digit product format 003630032
Labeler code 0363
Product ID 0363-0032_b95a197f-f5b0-45a5-b084-8ccb4202912a
Type HUMAN OTC DRUG
Nonproprietary name minoxidil
Dosage form SOLUTION
Route TOPICAL
Labeler Walgreen Company
Application ANDA075598
Marketing category ANDA
Marketing start 2020-06-01
Substance MINOXIDIL
Active strength 5 g/100mL
Pharmacologic classes Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 44 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 2026-10-15 13:18:30 2026-09 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 c2088c7a36db…2026-09-14 22:38:34 2026-08 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 caaa826d4ba7…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…
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 hair regrowth treatment
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MINOXIDIL 5 g/100mL
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 311724 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 0363-0032-16 hair regrowth treatment 60 mL in 1 BOTTLE SOLUTION 60 5 0363-0032-16 hair regrowth treatment 1 in 1 CARTON SOLUTION 1 5 0363-0032-30 hair regrowth treatment 60 mL in 1 BOTTLE SOLUTION 60 5 0363-0032-30 hair regrowth treatment 3 in 1 CARTON SOLUTION 3 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0363-0032 HAIR REGROWTH TREATMENT (MINOXIDIL) SOLUTION [WALGREEN COMPANY] 4 Current NDC, Legacy NDC, 4 package rows 20220622_fb2a8bfe-7eae-4a78-a610-58c9e80adf72.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 0363-0032-16 00363003216 1 BOTTLE in 1 CARTON (0363-0032-16) / 60 mL in 1 BOTTLE 1 bottle 2020-06-01 0000-00-00 No No Current 0363-0032-30 00363003230 3 BOTTLE in 1 CARTON (0363-0032-30) / 60 mL in 1 BOTTLE 3 bottle 2020-06-01 0000-00-00 No No Current