minoxidil

Product NDC
0113-5129
11-digit product format
001135129
Labeler code
0113
Product ID
0113-5129_f0c2ab65-44cc-4f8f-80a9-f3b4f507670f
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
L. Perrigo Company
Application
ANDA091344
Marketing category
ANDA
Marketing start
2024-03-08
Substance
MINOXIDIL
Active strength
50 mg/g
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091344-001MINOXIDILMINOXIDIL5%AEROSOL, FOAM / TOPICAL2011-04-28

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A091344-001MINOXIDIL5%AEROSOL, FOAM / TOPICAL2011-04-2884e616aacf4f…
2026-08-18 06:07:402026-07A091344-001MINOXIDIL5%AEROSOL, FOAM / TOPICAL2011-04-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091344-001MINOXIDIL5%AEROSOL, FOAM / TOPICAL2011-04-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091344-001MINOXIDIL5%AEROSOL, FOAM / TOPICAL2011-04-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A091344-001MINOXIDIL5%AEROSOL, FOAM / TOPICAL2011-04-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091344-001MINOXIDIL5%AEROSOL, FOAM / TOPICAL2011-04-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091344-001MINOXIDIL5%AEROSOL, FOAM / TOPICAL2011-04-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091344-001MINOXIDIL5%AEROSOL, FOAM / TOPICAL2011-04-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091344-001MINOXIDIL5%AEROSOL, FOAM / TOPICAL2011-04-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091344-001MINOXIDIL5%AEROSOL, FOAM / TOPICAL2011-04-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091344-001MINOXIDIL5%AEROSOL, FOAM / TOPICAL2011-04-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091344-001MINOXIDIL5%AEROSOL, FOAM / TOPICAL2011-04-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091344-001MINOXIDIL5%AEROSOL, FOAM / TOPICAL2011-04-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091344-001MINOXIDIL5%AEROSOL, FOAM / TOPICAL2011-04-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091344-001MINOXIDIL5%AEROSOL, FOAM / TOPICAL2011-04-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091344-001MINOXIDIL5%AEROSOL, FOAM / TOPICAL2011-04-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091344-001MINOXIDIL5%AEROSOL, FOAM / TOPICAL2011-04-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091344-001MINOXIDIL5%AEROSOL, FOAM / TOPICAL2011-04-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091344-001MINOXIDIL5%AEROSOL, FOAM / TOPICAL2011-04-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091344-001MINOXIDIL5%AEROSOL, FOAM / TOPICAL2011-04-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091344-001MINOXIDIL5%AEROSOL, FOAM / TOPICAL2011-04-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091344-001MINOXIDIL5%AEROSOL, FOAM / TOPICAL2011-04-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091344-001MINOXIDIL5%AEROSOL, FOAM / TOPICAL2011-04-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A091344-001MINOXIDIL5%AEROSOL, FOAM / TOPICAL2011-04-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091344-001MINOXIDIL5%AEROSOL, FOAM / TOPICAL2011-04-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091344-001MINOXIDIL5%AEROSOL, FOAM / TOPICAL2011-04-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091344-001MINOXIDIL5%AEROSOL, FOAM / TOPICAL2011-04-283f01610625f2…
2019-09-15 20:21 UTC2019-09A091344-001MINOXIDIL5%AEROSOL, FOAM / TOPICAL2011-04-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A091344-001MINOXIDIL5%AEROSOL, FOAM / TOPICAL2011-04-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091344-001MINOXIDIL5%AEROSOL, FOAM / TOPICAL2011-04-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091344-001MINOXIDIL5%AEROSOL, FOAM / TOPICAL2011-04-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091344-001MINOXIDIL5%AEROSOL, FOAM / TOPICAL2011-04-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091344-001MINOXIDIL5%AEROSOL, FOAM / TOPICAL2011-04-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091344-001MINOXIDIL5%AEROSOL, FOAM / TOPICAL2011-04-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091344-001MINOXIDIL5%AEROSOL, FOAM / TOPICAL2011-04-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091344-001MINOXIDIL5%AEROSOL, FOAM / TOPICAL2011-04-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A091344-001MINOXIDIL5%AEROSOL, FOAM / TOPICAL2011-04-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A091344-001MINOXIDIL5%AEROSOL, FOAM / TOPICAL2011-04-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091344-001MINOXIDIL5%AEROSOL, FOAM / TOPICAL2011-04-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091344-001MINOXIDIL5%AEROSOL, FOAM / TOPICAL2011-04-28f41ea6bd6efb…

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
minoxidil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOXIDIL50 mg/g

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
645146Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ec91e5f2-f9c4-4a1d-a94c-3b7352339dabAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0113-5129-01minoxidil60 g in 1 CANAEROSOL, FOAM604
0113-5129-06minoxidil6 in 1 CARTONAEROSOL, FOAM64
0113-5129-06minoxidil60 g in 1 CANAEROSOL, FOAM604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-5129MINOXIDIL AEROSOL, FOAM [L. PERRIGO COMPANY]4Current NDC, 3 package rows20240522_ec91e5f2-f9c4-4a1d-a94c-3b7352339dab.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 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
hers hair regrowth treatmentMINOXIDILHims Inc77b917ec-65ea-4c7c-941e-fc37f598294b2022-04-18WarningsExact identifier
application applno (ANDA): 091344
application number: ANDA091344
equate hair regrowth treatmentMINOXIDILWal-Mart Stores Incb5327990-654f-4c1f-8cd4-95470f12d7672022-03-09WarningsExact identifier
application applno (ANDA): 091344
application number: ANDA091344
Good Sense Hair Regrowth TreatmentMINOXIDILL. Perrigo Company6f939158-eb96-4479-9a4a-f5a11aa882952021-09-13WarningsExact identifier
application applno (ANDA): 091344
application number: ANDA091344

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
645146minoxidil 5 % Topical FoamPSNec91e5f2-f9c4-4a1d-a94c-3b7352339dab4
645146minoxidil 50 MG/ML Topical FoamSCDec91e5f2-f9c4-4a1d-a94c-3b7352339dab4
645146minoxidil 5 % Topical FoamSYec91e5f2-f9c4-4a1d-a94c-3b7352339dab4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0113-5129-010011351290160 g in 1 CAN (0113-5129-01) 60 g2024-03-08NoNoCurrent
0113-5129-06001135129066 CAN in 1 CARTON (0113-5129-06) / 60 g in 1 CAN6 can2024-03-08NoNoCurrent