Minoxidil

Product NDC
0363-9973
11-digit product format
003639973
Labeler code
0363
Product ID
0363-9973_d0118cc5-f74a-4241-b0cb-8087db002f93
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Walgreens
Application
ANDA075518
Marketing category
ANDA
Marketing start
2022-10-14
Substance
MINOXIDIL
Active strength
50 mg/mL
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 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)MINOXIDIL5%SOLUTION / TOPICAL2000-11-17

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-173f01610625f2…
2019-09-15 20:21 UTC2019-09A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Minoxidil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOXIDIL50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5965120SH1Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311724Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a08edb99-3e45-4d3c-a0f8-c74bd291057aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-9973-06Minoxidil3 in 1 CARTONSOLUTION33
0363-9973-06Minoxidil60 mL in 1 BOTTLE, DROPPERSOLUTION603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9973MINOXIDIL SOLUTION [WALGREENS]3Current NDC, Legacy NDC, 2 package rows20250130_a08edb99-3e45-4d3c-a0f8-c74bd291057a.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hair Regrowth Treatment Extra Strength for MenMINOXIDILSeiseidou America, Inc.1bcb9934-861c-405a-948a-3e4cdd13246d2025-10-08WarningsExact identifier
application applno (ANDA): 075518
application number: ANDA075518
MinoxidilMINOXIDILWalgreensa08edb99-3e45-4d3c-a0f8-c74bd291057a2025-01-28WarningsExact identifier
application applno (ANDA): 075518
application number: ANDA075518
ndc (product): 0363-9973
MinoxidilMINOXIDILWalgreens97d4d3ce-316c-4d58-b4dc-28d662b0fb4a2023-10-11WarningsExact identifier
application applno (ANDA): 075518
application number: ANDA075518

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311724minoxidil 5 % Topical SolutionPSNa08edb99-3e45-4d3c-a0f8-c74bd291057a3
311724minoxidil 50 MG/ML Topical SolutionSCDa08edb99-3e45-4d3c-a0f8-c74bd291057a3
311724minoxidil 3 GM per 60 ML Topical SolutionSYa08edb99-3e45-4d3c-a0f8-c74bd291057a3
311724minoxidil 5 % Topical SolutionSYa08edb99-3e45-4d3c-a0f8-c74bd291057a3
311724minoxidil 5 GM per 100 ML Topical SolutionSYa08edb99-3e45-4d3c-a0f8-c74bd291057a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-9973-06003639973063 BOTTLE, DROPPER in 1 CARTON (0363-9973-06) / 60 mL in 1 BOTTLE, DROPPER2022-10-140000-00-00NoNoCurrent