FDA.reportPublic FDA data

REMIXDIL HAIR REGROWTH TREATMENT FOR WOMEN

Product NDC
83004-009
11-digit product format
830040009
Labeler code
83004
Product ID
83004-009_2efdf23e-eff7-ee51-e063-6394a90ad074
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil 2%
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Rida LLC
Application
ANDA078176
Marketing category
ANDA
Marketing start
2023-11-22
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

Additional Listing Data#

Finished product
Yes
Brand name base
REMIXDIL HAIR REGROWTH TREATMENT FOR WOMEN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOXIDIL2 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5965120SH1
Rxcui311723

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83004-009-012025-02-25C16284748780-12cef2736-79aa-d83d-e063-dadaa90ab31f0d027e41-8acb-43c0-b9e4-4d3208dc7b37
83004-009-012025-01-30C16284748780-12cef2736-79aa-d83d-e063-dadaa90ab31f0d027e41-8acb-43c0-b9e4-4d3208dc7b37

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83004-009-01REMIXDIL HAIR REGROWTH TREATMENT FOR WOMEN4 in 1 BOXSOLUTION43
83004-009-01REMIXDIL HAIR REGROWTH TREATMENT FOR WOMEN60 mL in 1 BOTTLESOLUTION603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83004-009REMIXDIL HAIR REGROWTH TREATMENT FOR WOMEN (MINOXIDIL 2%) SOLUTION [RIDA LLC]3Current NDC, 2 package rows20250227_0d027e41-8acb-43c0-b9e4-4d3208dc7b37.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311723minoxidil 2 % Topical SolutionPSN0d027e41-8acb-43c0-b9e4-4d3208dc7b373
311723minoxidil 20 MG/ML Topical SolutionSCD0d027e41-8acb-43c0-b9e4-4d3208dc7b373
311723minoxidil 2 % Topical SolutionSY0d027e41-8acb-43c0-b9e4-4d3208dc7b373
311723minoxidil 2 GM per 100 ML Topical SolutionSY0d027e41-8acb-43c0-b9e4-4d3208dc7b373

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83004-009-01830040009014 BOTTLE in 1 BOX (83004-009-01) / 60 mL in 1 BOTTLE4 bottle2023-11-22NoNoHistorical