Keeps

Product NDC
71713-095
11-digit product format
717130095
Labeler code
71713
Product ID
71713-095_6195d34f-48d8-8190-e053-2a91aa0a8638
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil 5%
Dosage form
LIQUID
Route
TOPICAL
Labeler
Thirty Madison Inc
Application
ANDA074588
Marketing category
ANDA
Marketing start
2017-11-15
Marketing end
0000-00-00
Substance
MINOXIDIL
Active strength
50 mg/mL
NDC exclude flag
E
Listing certified through
2018-12-31
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 productproduct71713-095IInactivated by FDA2026-08-03
excluded packagepackage71713-09571713-095-10IInactivated by FDA2026-08-03

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 NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71713-095-10IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71713-095-10IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71713-095-10IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71713-095-10IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71713-095-10IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71713-095-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71713-095-10IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71713-095-10IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71713-095-10IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71713-095-10IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71713-095-10IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71713-095-10IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage71713-095-10IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71713-095-10IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71713-095-10IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage71713-095-10IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage71713-095-10IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage71713-095-10IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage71713-095-10IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage71713-095-10IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage71713-095-10IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage71713-095-10EExcluded after deficient or non-compliant submission was not corrected110d247fa046…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
A074588-001MINOXIDIL (FOR MEN)MINOXIDIL2%SOLUTION / TOPICAL1996-04-05

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 UTC2026-02A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-0587673890dc5c…
2021-03-12 10:30 UTC2021-03A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-053f01610625f2…
2019-09-15 20:21 UTC2019-09A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05b00525d2431f…
2019-07-19 19:46 UTC2019-07A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-053f0d92c62455…
2023-05-13 08:27 UTC2023-05A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05053a50430f4f…
2023-01-26 05:58 UTC2023-01A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71713-095-102020-01-31C16284748780-19d75b9d0-179e-f424-e053-dadaa90a57ce5edbb188-5df6-8b87-e053-2991aa0a34f7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71713-095-10Keeps3 in 1 BOXLIQUID32
71713-095-10Keeps60 mL in 1 BOTTLE, PLASTICLIQUID602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71713-095KEEPS (MINOXIDIL 5%) LIQUID [THIRTY MADISON INC]2Legacy NDC, 2 package rows20171231_5edbb188-5df6-8b87-e053-2991aa0a34f7.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MinoxidilMINOXIDILWalgreensb55198cb-40d8-432b-bdd5-2ecefa35d3202025-05-21WarningsExact identifier
application applno (ANDA): 074588
application number: ANDA074588

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311724minoxidil 5 % Topical SolutionPSN5edbb188-5df6-8b87-e053-2991aa0a34f72
311724minoxidil 50 MG/ML Topical SolutionSCD5edbb188-5df6-8b87-e053-2991aa0a34f72
311724minoxidil 3 GM per 60 ML Topical SolutionSY5edbb188-5df6-8b87-e053-2991aa0a34f72
311724minoxidil 5 % Topical SolutionSY5edbb188-5df6-8b87-e053-2991aa0a34f72
311724minoxidil 5 GM per 100 ML Topical SolutionSY5edbb188-5df6-8b87-e053-2991aa0a34f72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
71713-095-10717130095103 in 1 BOXHistorical