kirkland signature minoxidil

Product NDC
63981-032
11-digit product format
639810032
Labeler code
63981
Product ID
63981-032_aa567142-cc73-47ef-bbd9-b212cfbe30d4
Type
HUMAN OTC DRUG
Nonproprietary name
minoxidil
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Costco Wholesale Company
Application
ANDA075598
Marketing category
ANDA
Marketing start
2021-05-13
Substance
MINOXIDIL
Active strength
5 g/100mL
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 44.

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
A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)MINOXIDIL5%SOLUTION / TOPICAL2001-06-13

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13c2088c7a36db…
2026-09-14 22:38:342026-08A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-1384e616aacf4f…
2026-08-18 06:07:402026-07A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-1387673890dc5c…
2021-03-12 10:30 UTC2021-03A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-133f01610625f2…
2019-09-15 20:21 UTC2019-09A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13b00525d2431f…
2019-07-19 19:46 UTC2019-07A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-133f0d92c62455…
2023-05-13 08:27 UTC2023-05A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13053a50430f4f…
2023-01-26 05:58 UTC2023-01A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-133a93d1ddd44b…

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
kirkland signature minoxidil
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOXIDIL5 g/100mL

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
311724Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ec4b79fd-f68b-4f8d-a173-983835bc82ebAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63981-032-16kirkland signature minoxidil60 mL in 1 BOTTLE, DROPPERSOLUTION603
63981-032-40kirkland signature minoxidil6 in 1 CARTONSOLUTION63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63981-032KIRKLAND SIGNATURE MINOXIDIL (MINOXIDIL) SOLUTION [COSTCO WHOLESALE COMPANY]3Current NDC, Legacy NDC, 2 package rows20250206_ec4b79fd-f68b-4f8d-a173-983835bc82eb.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
Leader MinoxidilMINOXIDILCardinal Health 110, LLC. dba Leaderfbb17735-6c1f-44d6-865b-feec83a66b692024-03-04WarningsExact identifier
application applno (ANDA): 075598
application number: ANDA075598
equate hair regrowth treatmentMINOXIDILWal-Mart Stores Inc98f780ad-dc07-4d37-a05d-fc7b45b0c4742021-09-29WarningsExact identifier
application applno (ANDA): 075598
application number: ANDA075598

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311724minoxidil 5 % Topical SolutionPSNec4b79fd-f68b-4f8d-a173-983835bc82eb3
311724minoxidil 50 MG/ML Topical SolutionSCDec4b79fd-f68b-4f8d-a173-983835bc82eb3
311724minoxidil 3 GM per 60 ML Topical SolutionSYec4b79fd-f68b-4f8d-a173-983835bc82eb3
311724minoxidil 5 % Topical SolutionSYec4b79fd-f68b-4f8d-a173-983835bc82eb3
311724minoxidil 5 GM per 100 ML Topical SolutionSYec4b79fd-f68b-4f8d-a173-983835bc82eb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63981-032-166398100321660 mL in 1 BOTTLE, DROPPER60 mlHistorical
63981-032-40639810032406 BOTTLE, DROPPER in 1 CARTON (63981-032-40) / 60 mL in 1 BOTTLE, DROPPER (63981-032-16) 2021-05-130000-00-00NoNoCurrent