Toppik Womens Hair Regrowth Treatment

Product NDC
61355-569
11-digit product format
613550569
Labeler code
61355
Product ID
61355-569_b4e44dcb-765c-40dc-87be-4c7bc3bfbd09
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Spencer Forrest, Inc.
Application
ANDA078176
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
MINOXIDIL
Active strength
20 mg/mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61355-569IInactivated by FDA2026-08-11
excluded packagepackage61355-56961355-569-60IInactivated by FDA2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61355-569-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61355-569-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61355-569-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61355-569-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61355-569-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61355-569-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61355-569-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61355-569-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61355-569-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61355-569-60ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61355-569-60367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61355-569-60557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61355-569-608af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61355-569-60834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61355-569-601332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage61355-569-60fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage61355-569-6086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage61355-569-60bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage61355-569-608dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage61355-569-60e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage61355-569-609bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage61355-569-60110d247fa046…a55b01930146…

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…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61355-569-602019-11-27C16284748780-19855e2a2-3639-60a7-e053-dbdaa90a05bdToppik Women's Hair Regrowth Treatment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61355-569-60Toppik Womens Hair Regrowth Treatment1 in 1 CANISTERSOLUTION11
61355-569-60Toppik Womens Hair Regrowth Treatment60 mL in 1 BOTTLE, SPRAYSOLUTION601

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61355-569TOPPIK WOMENS HAIR REGROWTH TREATMENT (MINOXIDIL) SOLUTION [SPENCER FORREST, INC.]1Legacy NDC, 2 package rows20140522_27a98d58-d8f1-4059-a250-6757e0c84bc0.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
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
1537947minoxidil 2 % Topical SprayPSN27a98d58-d8f1-4059-a250-6757e0c84bc01
1537947minoxidil 20 MG/ML Topical SpraySCD27a98d58-d8f1-4059-a250-6757e0c84bc01
1537947minoxidil 2 % Topical SpraySY27a98d58-d8f1-4059-a250-6757e0c84bc01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61355-569-60613550569601 in 1 CANISTERHistorical