Home NDC 63981-380 Kirkland Signature Minoxidil
Product NDC 63981-380
11-digit product format 639810380
Labeler code 63981
Product ID 63981-380_4368eea4-afbd-4fb3-96d6-7a3ca92abb97
Type HUMAN OTC DRUG
Nonproprietary name Minoxidil
Dosage form SOLUTION
Route TOPICAL
Labeler Costco Wholesale Company
Application ANDA075598
Marketing category ANDA
Marketing start 2013-08-25
Marketing end 0000-00-00
Substance MINOXIDIL
Active strength 5 g/100mL
Pharmacologic classes Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) MINOXIDIL 5% SOLUTION / TOPICAL 2001-06-13
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 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 f41ea6bd6efb…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63981-380 KIRKLAND SIGNATURE MINOXIDIL (MINOXIDIL) SOLUTION [COSTCO WHOLESALE COMPANY] 5 Legacy NDC 20221209_69b4602f-05cc-41d8-9dad-3ec434001328.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 2 · 22 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63981-380-40 63981038040 6 BOTTLE in 1 CARTON (63981-380-40) > 60 mL in 1 BOTTLE (63981-380-16) 6 bottle 2013-08-25 0000-00-00 No No Current