Home NDC 25280-007 Loesch Hair Regrowth Formula
Product NDC 25280-007
11-digit product format 252800007
Labeler code 25280
Product ID 25280-007_450ff49f-aebe-f82f-e063-6394a90a4ed5
Type HUMAN OTC DRUG
Nonproprietary name minoxidil
Dosage form SOLUTION
Route TOPICAL
Labeler Loesch Laboratory Consultant, INC.
Application ANDA075357
Marketing category ANDA
Marketing start 2014-08-11
Substance MINOXIDIL
Active strength 2 g/100mL
Pharmacologic classes Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 Dataset Scope Product NDC Package NDC Code Status Reporting period Source date excluded product product 25280-007 E Excluded after deficient or non-compliant submission was not corrected 2026-08-17 excluded package package 25280-007 25280-007-42 E Excluded after deficient or non-compliant submission was not corrected 2026-08-17
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 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 25280-007-42 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 25280-007-42 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 25280-007-42 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 25280-007-42 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 25280-007-42 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 25280-007-42 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 25280-007-42 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 25280-007-42 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 25280-007-42 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075357-001 MINOXIDIL (FOR MEN) MINOXIDIL 2% SOLUTION / TOPICAL 1999-07-30 A075357-002 MINOXIDIL (FOR WOMEN) MINOXIDIL 2% SOLUTION / TOPICAL 1999-07-30
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 3 · 84 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 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 bb7c543d1eb4…
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 25280-007-42 Loesch Hair Regrowth FormulaUnscented Topical Solution Regular-Strength for Men and Women 1 in 1 PACKAGE SOLUTION 1 6 25280-007-42 Loesch Hair Regrowth FormulaUnscented Topical Solution Regular-Strength for Men and Women 60 mL in 1 BOTTLE, WITH APPLICATOR SOLUTION 60 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 25280-007 LOESCH HAIR REGROWTH FORMULA UNSCENTED TOPICAL SOLUTION REGULAR-STRENGTH FOR MEN AND WOMEN (MINOXIDIL) SOLUTION [LOESCH LABORATORY CONSULTANT, INC.] 5 Current NDC, Legacy NDC, 2 package rows 20191127_b9ff7a22-74be-4968-a260-576c7348dfb1.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 · 18 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 25280-007-42 25280000742 1 BOTTLE, WITH APPLICATOR in 1 PACKAGE (25280-007-42) / 60 mL in 1 BOTTLE, WITH APPLICATOR 2014-08-11 0000-00-00 No No Current