GROWELL Womens Hair Regrowth Treatment 2 Minoxidil

Product NDC
84329-466
Requested package NDC
84329-466-00
11-digit product format
843290466
Labeler code
84329
Product ID
84329-466_189129cb-e2fa-59f0-e063-6394a90a33b2
Type
HUMAN OTC DRUG
Nonproprietary name
MINOXIDIL
Dosage form
LIQUID
Route
TOPICAL
Labeler
APIRA SCIENCE, INC.
Application
ANDA078176
Marketing category
ANDA
Marketing start
2024-03-04
Substance
MINOXIDIL
Active strength
20 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 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
A078176-001THEROXIDILMINOXIDIL2%SOLUTION / TOPICAL2007-11-09

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 UTC2026-02A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-0987673890dc5c…
2021-03-12 10:30 UTC2021-03A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-098869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-093f01610625f2…
2019-09-15 20:21 UTC2019-09A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09b00525d2431f…
2019-07-19 19:46 UTC2019-07A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-093f0d92c62455…
2023-05-13 08:27 UTC2023-05A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09053a50430f4f…
2023-01-26 05:58 UTC2023-01A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-093a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
GROWELL Womens Hair Regrowth Treatment 2 Minoxidil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOXIDIL20 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
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
8b81a5e5-315e-4b7d-8ffd-623382294d8aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84329-466-00GROWELL Womens Hair Regrowth Treatment 2 Minoxidil1 in 1 BOXLIQUID11
84329-466-00GROWELL Womens Hair Regrowth Treatment 2 Minoxidil60 mL in 1 BOTTLE, DROPPERLIQUID601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84329-466GROWELL WOMENS HAIR REGROWTH TREATMENT 2 MINOXIDIL (MINOXIDIL) LIQUID [APIRA SCIENCE, INC.]1Current NDC, 2 package rows20240517_8b81a5e5-315e-4b7d-8ffd-623382294d8a.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 · 18 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Foligain Professional Series Extra Strength for Women Minoxidil Topical Hair Regrowth TreatmentMINOXIDILWR Group, Inc.a765cc59-ab59-4e49-ba28-926a2e0a78b12026-05-13WarningsExact identifier
application applno (ANDA): 078176
application number: ANDA078176
MDhair hair regrowth treatment for womenMINOXIDIL 2%MDalgorithms, Incc3ba93d7-e826-f6ac-e053-2a95a90a79512026-04-24WarningsExact identifier
application applno (ANDA): 078176
application number: ANDA078176
Minoxidil Topical Solution USP, 2%MINOXIDIL 2%Carol's Daughter, LLC4d659f8f-b721-cf3b-e063-6394a90a50f62026-03-19WarningsExact identifier
application applno (ANDA): 078176
application number: ANDA078176
Fete Health Hair Regrowth Treatment for WomenMINOXIDILHonest Pharma LLC93f7a89b-65f1-4a58-af75-2eeb0e47a8f82026-02-11WarningsExact identifier
application applno (ANDA): 078176
application number: ANDA078176
Womens MinoGrow Hair Regrowth Treatment MinoxidilMINOXIDILMinogro Products, LLC890c2acf-0c08-4c45-b29f-928b6155ca002026-02-03WarningsExact identifier
application applno (ANDA): 078176
application number: ANDA078176
Happy Head Womens Hair Regrowth TreatmentMINOXIDILHappy Head, Inc1e447c66-a8c9-42a4-94e9-b8739543834e2025-09-24WarningsExact identifier
application applno (ANDA): 078176
application number: ANDA078176
Gemachlich ZuHause Hair Growth Foam (Women)HAIR GROWTH FOAM (WOMEN)Guangdong Quadrant Ecological Technology Co., Ltd.3af47ccf-dde0-4f8a-e063-6294a90a28d82025-07-27WarningsExact identifier
application applno (ANDA): 078176
application number: ANDA078176
REMIXDIL HAIR REGROWTH TREATMENT FOR WOMENMINOXIDIL 2%Rida LLC0d027e41-8acb-43c0-b9e4-4d3208dc7b372025-02-25WarningsExact identifier
application applno (ANDA): 078176
application number: ANDA078176
Santo Remedio Mens Hair Regrowth Treatment Minoxidil Topical Solution Extra Strength UnscentedMINOXIDILSANTO REMEDIO LLC2a2d814f-d716-6e60-e063-6294a90aeb972024-12-26WarningsExact identifier
application applno (ANDA): 078176
application number: ANDA078176
Santo Remedio Womens Hair Regrowth Treatment Minoxidil UnscentedMINOXIDILSANTO REMEDIO LLCcfc7adf1-627b-41e1-b51a-cdcd8a14e7962024-12-18WarningsExact identifier
application applno (ANDA): 078176
application number: ANDA078176
The Root Of Goodness Healthy Growth Hair Regrowth System For Women 3 Step SystemMINOXIDILInvest Strong, LLC2e19bf51-1769-4bc1-9232-9aa4b8df58472024-12-05WarningsExact identifier
application applno (ANDA): 078176
application number: ANDA078176
eSalon Hair Regrowth Treatment Womens MinoxidilMINOXIDILESALON.COM, LLCc3951cc3-83c1-4d9d-8fbe-db6f1fb3986c2024-11-05WarningsExact identifier
application applno (ANDA): 078176
application number: ANDA078176
KERANIQUE Hair Regrowth Treatment For WomenMINOXIDILPROFECTUS BEAUTY, LLC8d580c01-a13d-81f8-e053-2a95a90a74262024-08-22WarningsExact identifier
application applno (ANDA): 078176
application number: ANDA078176
Keranique 2% Hair Regrowth Treatment for WomenMINOXIDILPROFECTUS BEAUTY, LLCc781447a-10f1-70e3-e053-2995a90a40f82024-08-22WarningsExact identifier
application applno (ANDA): 078176
application number: ANDA078176
GROWELL Womens Hair Regrowth Treatment 2 MinoxidilMINOXIDILAPIRA SCIENCE, INC.8b81a5e5-315e-4b7d-8ffd-623382294d8a2024-05-16WarningsExact identifier
application applno (ANDA): 078176
application number: ANDA078176
ndc (package): 84329-466-00
ndc (product): 84329-466
ndc11 (package): 84329046600
BOSLEY Minoxidil Topical Solution 2 for WomenMINOXIDILScientific Hair Research, LLC4fe1602f-797a-4469-b82c-3ade8a9c7fec2024-02-21WarningsExact identifier
application applno (ANDA): 078176
application number: ANDA078176
BOSLEY Woman 2 Minoxidil Topical SolutionMINOXIDILScientific Hair Research, LLCa70d0bd4-ac02-4a55-b9e7-c20dfe830f082023-12-18WarningsExact identifier
application applno (ANDA): 078176
application number: ANDA078176
Womens Minoxidil Hair Growth SystemMINOXIDILTopiderm, Inc.6cd3532a-1c1d-44bb-9f7e-c9dc085e2f962021-04-23WarningsExact identifier
application applno (ANDA): 078176
application number: ANDA078176

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311723minoxidil 2 % Topical SolutionPSN8b81a5e5-315e-4b7d-8ffd-623382294d8a1
311723minoxidil 20 MG/ML Topical SolutionSCD8b81a5e5-315e-4b7d-8ffd-623382294d8a1
311723minoxidil 2 % Topical SolutionSY8b81a5e5-315e-4b7d-8ffd-623382294d8a1
311723minoxidil 2 GM per 100 ML Topical SolutionSY8b81a5e5-315e-4b7d-8ffd-623382294d8a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
84329-466-00843290466001 BOTTLE, DROPPER in 1 BOX (84329-466-00) / 60 mL in 1 BOTTLE, DROPPER2024-03-04NoNoCurrent