Santo Remedio Mens Hair Regrowth Treatment Minoxidil Topical Solution Extra Strength Unscented

Product NDC
81352-560
11-digit product format
813520560
Labeler code
81352
Product ID
81352-560_2a2d74a0-c971-eeb1-e063-6394a90a9acd
Type
HUMAN OTC DRUG
Nonproprietary name
MINOXIDIL
Dosage form
SOLUTION
Route
TOPICAL
Labeler
SANTO REMEDIO LLC
Application
ANDA078176
Marketing category
ANDA
Marketing start
2024-11-08
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

Additional Listing Data#

Finished product
Yes
Brand name base
Santo Remedio Mens Hair Regrowth Treatment Minoxidil Topical Solution Extra Strength Unscented
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOXIDIL50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5965120SH1
Rxcui311724

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81352-560-00Santo Remedio Mens Hair Regrowth Treatment Minoxidil Topical Solution Extra Strength Unscented1 in 1 BOXSOLUTION11
81352-560-00Santo Remedio Mens Hair Regrowth Treatment Minoxidil Topical Solution Extra Strength Unscented60 mL in 1 BOTTLE, DROPPERSOLUTION601
81352-560-03Santo Remedio Mens Hair Regrowth Treatment Minoxidil Topical Solution Extra Strength Unscented3 in 1 BOXSOLUTION31
81352-560-03Santo Remedio Mens Hair Regrowth Treatment Minoxidil Topical Solution Extra Strength Unscented60 mL in 1 BOTTLE, DROPPERSOLUTION601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81352-560SANTO REMEDIO MENS HAIR REGROWTH TREATMENT MINOXIDIL TOPICAL SOLUTION EXTRA STRENGTH UNSCENTED (MINOXIDIL) SOLUTION [SANTO REMEDIO LLC]1Current NDC, 4 package rows20241228_2a2d814f-d716-6e60-e063-6294a90aeb97.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311724minoxidil 5 % Topical SolutionPSN2a2d814f-d716-6e60-e063-6294a90aeb971
311724minoxidil 50 MG/ML Topical SolutionSCD2a2d814f-d716-6e60-e063-6294a90aeb971
311724minoxidil 3 GM per 60 ML Topical SolutionSY2a2d814f-d716-6e60-e063-6294a90aeb971
311724minoxidil 5 % Topical SolutionSY2a2d814f-d716-6e60-e063-6294a90aeb971
311724minoxidil 5 GM per 100 ML Topical SolutionSY2a2d814f-d716-6e60-e063-6294a90aeb971

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
81352-560-00813520560001 BOTTLE, DROPPER in 1 BOX (81352-560-00) / 60 mL in 1 BOTTLE, DROPPER2024-11-08NoNoHistorical
81352-560-03813520560033 BOTTLE, DROPPER in 1 BOX (81352-560-03) / 60 mL in 1 BOTTLE, DROPPER2024-11-08NoNoHistorical