Home NDC 69968-0089 Mens Rogaine Extra Strength Unscented
Product NDC 69968-0089
11-digit product format 699680089
Labeler code 69968
Product ID 69968-0089_216de286-271e-8d0c-e063-6294a90a2fec
Type HUMAN OTC DRUG
Nonproprietary name Minoxidil
Dosage form SOLUTION
Route TOPICAL
Labeler Kenvue Brands LLC
Application NDA020834
Marketing category NDA
Marketing start 2010-07-16
Substance MINOXIDIL
Active strength 50 mg/mL
Pharmacologic classes Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020834-001 ROGAINE EXTRA STRENGTH (FOR MEN) MINOXIDIL 5% SOLUTION / TOPICAL RLD, RS 1997-11-14
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N020834-001 ROGAINE EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL RLD, RS 1997-11-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020834-001 ROGAINE EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL RLD, RS 1997-11-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020834-001 ROGAINE EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL RLD, RS 1997-11-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020834-001 ROGAINE EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL RLD, RS 1997-11-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020834-001 ROGAINE EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL RLD, RS 1997-11-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020834-001 ROGAINE EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL RLD, RS 1997-11-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020834-001 ROGAINE EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL RLD, RS 1997-11-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020834-001 ROGAINE EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL RLD, RS 1997-11-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020834-001 ROGAINE EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL RLD, RS 1997-11-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020834-001 ROGAINE EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL RLD, RS 1997-11-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020834-001 ROGAINE EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL RLD, RS 1997-11-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020834-001 ROGAINE EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL RLD, RS 1997-11-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020834-001 ROGAINE EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL RLD, RS 1997-11-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020834-001 ROGAINE EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL RLD, RS 1997-11-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020834-001 ROGAINE EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL RLD, RS 1997-11-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020834-001 ROGAINE EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL RLD, RS 1997-11-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020834-001 ROGAINE EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL RLD, RS 1997-11-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020834-001 ROGAINE EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL RLD, RS 1997-11-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020834-001 ROGAINE EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL RLD, RS 1997-11-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020834-001 ROGAINE EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL RLD, RS 1997-11-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020834-001 ROGAINE EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL RLD, RS 1997-11-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020834-001 ROGAINE EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL RLD, RS 1997-11-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020834-001 ROGAINE EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL RLD, RS 1997-11-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020834-001 ROGAINE EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL RLD, RS 1997-11-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020834-001 ROGAINE EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL RLD, RS 1997-11-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020834-001 ROGAINE EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL RLD, RS 1997-11-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020834-001 ROGAINE EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL RLD, RS 1997-11-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020834-001 ROGAINE EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL RLD, RS 1997-11-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020834-001 ROGAINE EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL RLD, RS 1997-11-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020834-001 ROGAINE EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL RLD, RS 1997-11-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020834-001 ROGAINE EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL RLD, RS 1997-11-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020834-001 ROGAINE EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL RLD, RS 1997-11-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020834-001 ROGAINE EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL RLD, RS 1997-11-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020834-001 ROGAINE EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL RLD, RS 1997-11-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020834-001 ROGAINE EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL RLD, RS 1997-11-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020834-001 ROGAINE EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL RLD, RS 1997-11-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020834-001 ROGAINE EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL RLD, RS 1997-11-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020834-001 ROGAINE EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL RLD, RS 1997-11-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020834-001 ROGAINE EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL RLD, RS 1997-11-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020834-001 ROGAINE EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL RLD, RS 1997-11-14 e64feba35796…
Additional Listing Data#
Finished product Yes
Brand name base Mens Rogaine Extra Strength Unscented
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MINOXIDIL 50 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5965120SH1 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311724 Internal RxNorm lookup 809031 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69968-0089-1 Mens Rogaine Extra Strength Unscented 60 mL in 1 BOTTLE, PLASTIC SOLUTION 60 5 69968-0089-1 Mens Rogaine Extra Strength Unscented 1 in 1 CARTON SOLUTION 1 5 69968-0089-3 Mens Rogaine Extra Strength Unscented 3 in 1 CARTON SOLUTION 3 5 69968-0089-3 Mens Rogaine Extra Strength Unscented 60 mL in 1 BOTTLE, PLASTIC SOLUTION 60 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69968-0089 MENS ROGAINE EXTRA STRENGTH UNSCENTED (MINOXIDIL) SOLUTION [KENVUE BRANDS LLC] 5 Current NDC, Legacy NDC, 4 package rows 20241102_ccaecec5-5348-4b24-9190-5464c50f6d80.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 69968-0089-1 69968008901 1 BOTTLE, PLASTIC in 1 CARTON (69968-0089-1) / 60 mL in 1 BOTTLE, PLASTIC 2010-07-16 0000-00-00 No No Current 69968-0089-3 69968008903 3 BOTTLE, PLASTIC in 1 CARTON (69968-0089-3) / 60 mL in 1 BOTTLE, PLASTIC 2010-07-16 0000-00-00 No No Current