Hair Growth Serum Roll-ON

Product NDC
85524-2625
11-digit product format
855242625
Labeler code
85524
Product ID
85524-2625_506c0a1b-b462-d535-e063-6294a90a4d20
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil
Dosage form
LIQUID
Route
TOPICAL
Labeler
FlexiGo Inc
Application
ANDA075438
Marketing category
ANDA
Marketing start
2026-04-03
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 1.

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
A075438-001MINOXIDIL EXTRA STRENGTH (FOR MEN)MINOXIDIL5%SOLUTION / TOPICAL2003-02-27

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075438-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2003-02-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075438-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2003-02-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A075438-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2003-02-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075438-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2003-02-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075438-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2003-02-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075438-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2003-02-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075438-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2003-02-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075438-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2003-02-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075438-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2003-02-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075438-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2003-02-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075438-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2003-02-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075438-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2003-02-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075438-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2003-02-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075438-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2003-02-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075438-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2003-02-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075438-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2003-02-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075438-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2003-02-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075438-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2003-02-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075438-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2003-02-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075438-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2003-02-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075438-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2003-02-2787673890dc5c…
2021-03-12 10:30 UTC2021-03A075438-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2003-02-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075438-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2003-02-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075438-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2003-02-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075438-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2003-02-273f01610625f2…
2019-09-15 20:21 UTC2019-09A075438-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2003-02-27b00525d2431f…
2019-07-19 19:46 UTC2019-07A075438-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2003-02-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075438-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2003-02-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075438-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2003-02-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075438-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2003-02-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075438-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2003-02-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075438-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2003-02-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075438-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2003-02-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075438-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2003-02-273f0d92c62455…
2023-05-13 08:27 UTC2023-05A075438-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2003-02-27053a50430f4f…
2023-01-26 05:58 UTC2023-01A075438-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2003-02-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075438-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2003-02-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075438-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2003-02-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075438-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2003-02-27e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075438-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2003-02-27cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Hair Growth Serum Roll-ON
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOXIDIL5 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
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
506c0a1b-b461-d535-e063-6294a90a4d20Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85524-2625-1Hair Growth Serum Roll-ON30 mL in 1 BOTTLELIQUID301
85524-2625-2Hair Growth Serum Roll-ON1 in 1 BOXLIQUID11

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
Hair Growth Serum Roll-ONMINOXIDILFlexiGo Inc506c0a1b-b461-d535-e063-6294a90a4d202026-04-27WarningsExact identifier
application applno (ANDA): 075438
application number: ANDA075438
ndc (product): 85524-2625

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311724minoxidil 5 % Topical SolutionPSN506c0a1b-b461-d535-e063-6294a90a4d201
311724minoxidil 50 MG/ML Topical SolutionSCD506c0a1b-b461-d535-e063-6294a90a4d201
311724minoxidil 3 GM per 60 ML Topical SolutionSY506c0a1b-b461-d535-e063-6294a90a4d201
311724minoxidil 5 % Topical SolutionSY506c0a1b-b461-d535-e063-6294a90a4d201
311724minoxidil 5 GM per 100 ML Topical SolutionSY506c0a1b-b461-d535-e063-6294a90a4d201

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85524-2625-18552426250130 mL in 1 BOTTLE30 mlHistorical
85524-2625-2855242625021 BOTTLE in 1 BOX (85524-2625-2) / 30 mL in 1 BOTTLE (85524-2625-1) 1 bottle2026-04-03YesNoCurrent