Mens Kirkland

Product NDC
63981-111
11-digit product format
639810111
Labeler code
63981
Product ID
63981-111_fc4ad05c-3d62-4450-8fad-95f1d4ffdc29
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Costco Wholesale Corporation
Application
NDA020834
Marketing category
NDA
Marketing start
2010-07-16
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 productproduct63981-111IInactivated by FDA2026-08-17
excluded packagepackage63981-11163981-111-01IInactivated by FDA2026-08-17

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 packagepackage63981-111-01IInactivated 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 packagepackage63981-111-01IInactivated 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 packagepackage63981-111-01IInactivated 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 packagepackage63981-111-01IInactivated 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 packagepackage63981-111-01IInactivated 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 packagepackage63981-111-01IInactivated 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 packagepackage63981-111-01IInactivated 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 packagepackage63981-111-01IInactivated 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 packagepackage63981-111-01IInactivated 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 packagepackage63981-111-01IInactivated 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 packagepackage63981-111-01IInactivated 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 packagepackage63981-111-01IInactivated 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 packagepackage63981-111-01IInactivated 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 packagepackage63981-111-01IInactivated 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 packagepackage63981-111-01IInactivated 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 packagepackage63981-111-01IInactivated 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 packagepackage63981-111-01IInactivated 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 packagepackage63981-111-01IInactivated 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 packagepackage63981-111-01IInactivated 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 packagepackage63981-111-01IInactivated 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 packagepackage63981-111-01IInactivated 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 packagepackage63981-111-01EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)MINOXIDIL5%SOLUTION / TOPICALRLD, RS1997-11-14

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-1487673890dc5c…
2021-03-12 10:30 UTC2021-03N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-143f01610625f2…
2019-09-15 20:21 UTC2019-09N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-14b00525d2431f…
2019-07-19 19:46 UTC2019-07N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-143f0d92c62455…
2023-05-13 08:27 UTC2023-05N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-14053a50430f4f…
2023-01-26 05:58 UTC2023-01N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-14e64feba35796…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63981-111-012020-01-31C16284748780-19d75b9d0-3034-f424-e053-dadaa90a57ceMen's Kirkland Extra Strength 5% Unscented Solution Carton

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63981-111-01Mens Kirkland Extra Strength12 in 1 TRAYSOLUTION121
63981-111-01Mens Kirkland Extra Strength2 in 1 PACKAGE, COMBINATIONSOLUTION21

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63981-111MENS KIRKLAND (MINOXIDIL) SOLUTION [COSTCO WHOLESALE CORPORATION]1Legacy NDC, 2 package rows20100921_ee71efe1-2505-4e9e-b1aa-ae8b6463596b.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
Mens Rogaine Extra Strength UnscentedMINOXIDILKenvue Brands LLCccaecec5-5348-4b24-9190-5464c50f6d802024-09-06WarningsExact identifier
application applno (NDA): 020834
application number: NDA020834

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311724minoxidil 5 % Topical SolutionPSNee71efe1-2505-4e9e-b1aa-ae8b6463596b1
311724minoxidil 50 MG/ML Topical SolutionSCDee71efe1-2505-4e9e-b1aa-ae8b6463596b1
311724minoxidil 3 GM per 60 ML Topical SolutionSYee71efe1-2505-4e9e-b1aa-ae8b6463596b1
311724minoxidil 5 % Topical SolutionSYee71efe1-2505-4e9e-b1aa-ae8b6463596b1
311724minoxidil 5 GM per 100 ML Topical SolutionSYee71efe1-2505-4e9e-b1aa-ae8b6463596b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63981-111-016398101110112 in 1 TRAYHistorical