hair regrowth treatment

Product NDC
41250-294
Requested package NDC
41250-294-01
11-digit product format
412500294
Labeler code
41250
Product ID
41250-294_b7b476d6-4ca1-4717-95be-ba057b3aa5fa
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
Meijer Distribution Inc
Application
ANDA091344
Marketing category
ANDA
Marketing start
2012-03-19
Substance
MINOXIDIL
Active strength
5 g/100g
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 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
hair regrowth treatment
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOXIDIL5 g/100g

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
a8a2b3c1-ecda-4fc9-b3fd-bb94cfee6e80Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-294-01hair regrowth treatment1 in 1 CARTONAEROSOL, FOAM18
41250-294-01hair regrowth treatment60 g in 1 CANAEROSOL, FOAM608
41250-294-03hair regrowth treatment3 in 1 CARTONAEROSOL, FOAM38
41250-294-03hair regrowth treatment60 g in 1 CANAEROSOL, FOAM608
41250-294-04hair regrowth treatment4 in 1 CARTONAEROSOL, FOAM48
41250-294-04hair regrowth treatment60 g in 1 CANAEROSOL, FOAM608

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MINOXIDILACTIVE INGREDIENT5965120SH1HAIR REGROWTH TREATMENT (MINOXIDIL) AEROSOL, FOAM [MEIJER DISTRIBUTION INC]2
MINOXIDILACTIVE MOIETY5965120SH1HAIR REGROWTH TREATMENT (MINOXIDIL) AEROSOL, FOAM [MEIJER DISTRIBUTION INC]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MHAIR REGROWTH TREATMENT (MINOXIDIL) AEROSOL, FOAM [MEIJER DISTRIBUTION INC]2
BUTANEINACTIVE INGREDIENT6LV4FOR43RHAIR REGROWTH TREATMENT (MINOXIDIL) AEROSOL, FOAM [MEIJER DISTRIBUTION INC]2
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KHAIR REGROWTH TREATMENT (MINOXIDIL) AEROSOL, FOAM [MEIJER DISTRIBUTION INC]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNHAIR REGROWTH TREATMENT (MINOXIDIL) AEROSOL, FOAM [MEIJER DISTRIBUTION INC]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPHAIR REGROWTH TREATMENT (MINOXIDIL) AEROSOL, FOAM [MEIJER DISTRIBUTION INC]2
ISOBUTANEINACTIVE INGREDIENTBXR49TP611HAIR REGROWTH TREATMENT (MINOXIDIL) AEROSOL, FOAM [MEIJER DISTRIBUTION INC]2
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATHAIR REGROWTH TREATMENT (MINOXIDIL) AEROSOL, FOAM [MEIJER DISTRIBUTION INC]2
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MHAIR REGROWTH TREATMENT (MINOXIDIL) AEROSOL, FOAM [MEIJER DISTRIBUTION INC]2
PROPANEINACTIVE INGREDIENTT75W9911L6HAIR REGROWTH TREATMENT (MINOXIDIL) AEROSOL, FOAM [MEIJER DISTRIBUTION INC]2
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YHAIR REGROWTH TREATMENT (MINOXIDIL) AEROSOL, FOAM [MEIJER DISTRIBUTION INC]2
WATERINACTIVE INGREDIENT059QF0KO0RHAIR REGROWTH TREATMENT (MINOXIDIL) AEROSOL, FOAM [MEIJER DISTRIBUTION INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-294HAIR REGROWTH TREATMENT (MINOXIDIL) AEROSOL, FOAM [MEIJER DISTRIBUTION INC]7Current NDC, Legacy NDC, 6 package rows20220629_a8a2b3c1-ecda-4fc9-b3fd-bb94cfee6e80.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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 FoamPSNa8a2b3c1-ecda-4fc9-b3fd-bb94cfee6e808
645146minoxidil 50 MG/ML Topical FoamSCDa8a2b3c1-ecda-4fc9-b3fd-bb94cfee6e808
645146minoxidil 5 % Topical FoamSYa8a2b3c1-ecda-4fc9-b3fd-bb94cfee6e808

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-294-01412500294011 CAN in 1 CARTON (41250-294-01) / 60 g in 1 CAN1 can2012-03-210000-00-00NoNoCurrent