Home NDC 57483-542 Regoxidine
Product NDC 57483-542
11-digit product format 574830542
Labeler code 57483
Product ID 57483-542_c311118f-5db6-4d28-a94b-5415ea14bbde
Type HUMAN OTC DRUG
Nonproprietary name Minoxidil
Dosage form SOLUTION
Route TOPICAL
Labeler Innovus Pharmaceuticals Inc.
Application ANDA078176
Marketing category ANDA
Marketing start 2021-04-19
Marketing end 0000-00-00
Substance MINOXIDIL
Active strength 2 g/100mL
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A078176-001 THEROXIDIL MINOXIDIL 2% SOLUTION / TOPICAL 2007-11-09
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 · 41 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 2026-02-19 14:30 UTC 2026-02 A078176-001 THEROXIDIL 2% SOLUTION / TOPICAL 2007-11-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078176-001 THEROXIDIL 2% SOLUTION / TOPICAL 2007-11-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078176-001 THEROXIDIL 2% SOLUTION / TOPICAL 2007-11-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078176-001 THEROXIDIL 2% SOLUTION / TOPICAL 2007-11-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078176-001 THEROXIDIL 2% SOLUTION / TOPICAL 2007-11-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078176-001 THEROXIDIL 2% SOLUTION / TOPICAL 2007-11-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078176-001 THEROXIDIL 2% SOLUTION / TOPICAL 2007-11-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078176-001 THEROXIDIL 2% SOLUTION / TOPICAL 2007-11-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078176-001 THEROXIDIL 2% SOLUTION / TOPICAL 2007-11-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078176-001 THEROXIDIL 2% SOLUTION / TOPICAL 2007-11-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078176-001 THEROXIDIL 2% SOLUTION / TOPICAL 2007-11-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078176-001 THEROXIDIL 2% SOLUTION / TOPICAL 2007-11-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078176-001 THEROXIDIL 2% SOLUTION / TOPICAL 2007-11-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078176-001 THEROXIDIL 2% SOLUTION / TOPICAL 2007-11-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078176-001 THEROXIDIL 2% SOLUTION / TOPICAL 2007-11-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078176-001 THEROXIDIL 2% SOLUTION / TOPICAL 2007-11-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078176-001 THEROXIDIL 2% SOLUTION / TOPICAL 2007-11-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078176-001 THEROXIDIL 2% SOLUTION / TOPICAL 2007-11-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078176-001 THEROXIDIL 2% SOLUTION / TOPICAL 2007-11-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078176-001 THEROXIDIL 2% SOLUTION / TOPICAL 2007-11-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078176-001 THEROXIDIL 2% SOLUTION / TOPICAL 2007-11-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078176-001 THEROXIDIL 2% SOLUTION / TOPICAL 2007-11-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078176-001 THEROXIDIL 2% SOLUTION / TOPICAL 2007-11-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078176-001 THEROXIDIL 2% SOLUTION / TOPICAL 2007-11-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078176-001 THEROXIDIL 2% SOLUTION / TOPICAL 2007-11-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078176-001 THEROXIDIL 2% SOLUTION / TOPICAL 2007-11-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078176-001 THEROXIDIL 2% SOLUTION / TOPICAL 2007-11-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078176-001 THEROXIDIL 2% SOLUTION / TOPICAL 2007-11-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078176-001 THEROXIDIL 2% SOLUTION / TOPICAL 2007-11-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078176-001 THEROXIDIL 2% SOLUTION / TOPICAL 2007-11-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078176-001 THEROXIDIL 2% SOLUTION / TOPICAL 2007-11-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078176-001 THEROXIDIL 2% SOLUTION / TOPICAL 2007-11-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078176-001 THEROXIDIL 2% SOLUTION / TOPICAL 2007-11-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078176-001 THEROXIDIL 2% SOLUTION / TOPICAL 2007-11-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078176-001 THEROXIDIL 2% SOLUTION / TOPICAL 2007-11-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078176-001 THEROXIDIL 2% SOLUTION / TOPICAL 2007-11-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078176-001 THEROXIDIL 2% SOLUTION / TOPICAL 2007-11-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078176-001 THEROXIDIL 2% SOLUTION / TOPICAL 2007-11-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078176-001 THEROXIDIL 2% SOLUTION / TOPICAL 2007-11-09 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078176-001 THEROXIDIL 2% SOLUTION / TOPICAL 2007-11-09 cb3db0bc1861…
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57483-542-03 Regoxidine 60 mL in 1 BOTTLE SOLUTION 60 5 57483-542-03 Regoxidine 3 in 1 CARTON SOLUTION 3 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57483-542 REGOXIDINE (MINOXIDIL) SOLUTION [INNOVUS PHARMACEUTICALS INC.] 5 Legacy NDC, 2 package rows 20241230_5842b4b7-674c-42f5-88ce-1ac629303bd4.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Foligain Professional Series Extra Strength for Women Minoxidil Topical Hair Regrowth Treatment MINOXIDIL WR Group, Inc. a765cc59-ab59-4e49-ba28-926a2e0a78b1 2026-05-13 Warnings Exact identifier application applno (ANDA): 078176 application number: ANDA078176 MDhair hair regrowth treatment for women MINOXIDIL 2% MDalgorithms, Inc c3ba93d7-e826-f6ac-e053-2a95a90a7951 2026-04-24 Warnings Exact identifier application applno (ANDA): 078176 application number: ANDA078176 Minoxidil Topical Solution USP, 2% MINOXIDIL 2% Carol's Daughter, LLC 4d659f8f-b721-cf3b-e063-6394a90a50f6 2026-03-19 Warnings Exact identifier application applno (ANDA): 078176 application number: ANDA078176 Fete Health Hair Regrowth Treatment for Women MINOXIDIL Honest Pharma LLC 93f7a89b-65f1-4a58-af75-2eeb0e47a8f8 2026-02-11 Warnings Exact identifier application applno (ANDA): 078176 application number: ANDA078176 Womens MinoGrow Hair Regrowth Treatment Minoxidil MINOXIDIL Minogro Products, LLC 890c2acf-0c08-4c45-b29f-928b6155ca00 2026-02-03 Warnings Exact identifier application applno (ANDA): 078176 application number: ANDA078176 Happy Head Womens Hair Regrowth Treatment MINOXIDIL Happy Head, Inc 1e447c66-a8c9-42a4-94e9-b8739543834e 2025-09-24 Warnings Exact identifier application applno (ANDA): 078176 application number: ANDA078176 Gemachlich ZuHause Hair Growth Foam (Women) HAIR GROWTH FOAM (WOMEN) Guangdong Quadrant Ecological Technology Co., Ltd. 3af47ccf-dde0-4f8a-e063-6294a90a28d8 2025-07-27 Warnings Exact identifier application applno (ANDA): 078176 application number: ANDA078176 REMIXDIL HAIR REGROWTH TREATMENT FOR WOMEN MINOXIDIL 2% Rida LLC 0d027e41-8acb-43c0-b9e4-4d3208dc7b37 2025-02-25 Warnings Exact identifier application applno (ANDA): 078176 application number: ANDA078176 Santo Remedio Mens Hair Regrowth Treatment Minoxidil Topical Solution Extra Strength Unscented MINOXIDIL SANTO REMEDIO LLC 2a2d814f-d716-6e60-e063-6294a90aeb97 2024-12-26 Warnings Exact identifier application applno (ANDA): 078176 application number: ANDA078176 Santo Remedio Womens Hair Regrowth Treatment Minoxidil Unscented MINOXIDIL SANTO REMEDIO LLC cfc7adf1-627b-41e1-b51a-cdcd8a14e796 2024-12-18 Warnings Exact identifier application applno (ANDA): 078176 application number: ANDA078176 The Root Of Goodness Healthy Growth Hair Regrowth System For Women 3 Step System MINOXIDIL Invest Strong, LLC 2e19bf51-1769-4bc1-9232-9aa4b8df5847 2024-12-05 Warnings Exact identifier application applno (ANDA): 078176 application number: ANDA078176 eSalon Hair Regrowth Treatment Womens Minoxidil MINOXIDIL ESALON.COM, LLC c3951cc3-83c1-4d9d-8fbe-db6f1fb3986c 2024-11-05 Warnings Exact identifier application applno (ANDA): 078176 application number: ANDA078176 KERANIQUE Hair Regrowth Treatment For Women MINOXIDIL PROFECTUS BEAUTY, LLC 8d580c01-a13d-81f8-e053-2a95a90a7426 2024-08-22 Warnings Exact identifier application applno (ANDA): 078176 application number: ANDA078176 Keranique 2% Hair Regrowth Treatment for Women MINOXIDIL PROFECTUS BEAUTY, LLC c781447a-10f1-70e3-e053-2995a90a40f8 2024-08-22 Warnings Exact identifier application applno (ANDA): 078176 application number: ANDA078176 GROWELL Womens Hair Regrowth Treatment 2 Minoxidil MINOXIDIL APIRA SCIENCE, INC. 8b81a5e5-315e-4b7d-8ffd-623382294d8a 2024-05-16 Warnings Exact identifier application applno (ANDA): 078176 application number: ANDA078176 BOSLEY Minoxidil Topical Solution 2 for Women MINOXIDIL Scientific Hair Research, LLC 4fe1602f-797a-4469-b82c-3ade8a9c7fec 2024-02-21 Warnings Exact identifier application applno (ANDA): 078176 application number: ANDA078176 BOSLEY Woman 2 Minoxidil Topical Solution MINOXIDIL Scientific Hair Research, LLC a70d0bd4-ac02-4a55-b9e7-c20dfe830f08 2023-12-18 Warnings Exact identifier application applno (ANDA): 078176 application number: ANDA078176 Womens Minoxidil Hair Growth System MINOXIDIL Topiderm, Inc. 6cd3532a-1c1d-44bb-9f7e-c9dc085e2f96 2021-04-23 Warnings Exact identifier application applno (ANDA): 078176 application number: ANDA078176
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 57483-542-03 57483054203 3 BOTTLE in 1 CARTON (57483-542-03) > 60 mL in 1 BOTTLE 3 bottle 2021-04-19 0000-00-00 No No Current