Minoxidil

Product NDC
0363-9970
11-digit product format
003639970
Labeler code
0363
Product ID
0363-9970_846eed96-0264-4212-9e53-227b8a12b28c
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Walgreens
Application
ANDA074588
Marketing category
ANDA
Marketing start
2022-10-14
Substance
MINOXIDIL
Active strength
2 g/100mL
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
A074588-001MINOXIDIL (FOR MEN)MINOXIDIL2%SOLUTION / TOPICAL1996-04-05

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 06:07:402026-07A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-0587673890dc5c…
2021-03-12 10:30 UTC2021-03A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-053f01610625f2…
2019-09-15 20:21 UTC2019-09A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05b00525d2431f…
2019-07-19 19:46 UTC2019-07A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-053f0d92c62455…
2023-05-13 08:27 UTC2023-05A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05053a50430f4f…
2023-01-26 05:58 UTC2023-01A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05e64feba35796…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOXIDIL2 g/100mL

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
311723Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b55198cb-40d8-432b-bdd5-2ecefa35d320Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-9970-02Minoxidil60 mL in 1 BOTTLE, DROPPERSOLUTION604
0363-9970-02Minoxidil1 in 1 CARTONSOLUTION14
0363-9970-06Minoxidil60 mL in 1 BOTTLE, DROPPERSOLUTION604
0363-9970-06Minoxidil3 in 1 CARTONSOLUTION34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9970MINOXIDIL SOLUTION [WALGREENS]4Current NDC, Legacy NDC, 4 package rows20250523_b55198cb-40d8-432b-bdd5-2ecefa35d320.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MinoxidilMINOXIDILWalgreensb55198cb-40d8-432b-bdd5-2ecefa35d3202025-05-21WarningsExact identifier
application applno (ANDA): 074588
application number: ANDA074588
ndc (product): 0363-9970

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311723minoxidil 2 % Topical SolutionPSNb55198cb-40d8-432b-bdd5-2ecefa35d3204
311723minoxidil 20 MG/ML Topical SolutionSCDb55198cb-40d8-432b-bdd5-2ecefa35d3204
311723minoxidil 2 % Topical SolutionSYb55198cb-40d8-432b-bdd5-2ecefa35d3204
311723minoxidil 2 GM per 100 ML Topical SolutionSYb55198cb-40d8-432b-bdd5-2ecefa35d3204

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-9970-02003639970021 BOTTLE, DROPPER in 1 CARTON (0363-9970-02) / 60 mL in 1 BOTTLE, DROPPER2022-10-140000-00-00NoNoCurrent
0363-9970-06003639970063 BOTTLE, DROPPER in 1 CARTON (0363-9970-06) / 60 mL in 1 BOTTLE, DROPPER2022-10-14NoNoCurrent