Peak Body Mens Hair Regrowth Treatment

Product NDC
83121-001
11-digit product format
831210001
Labeler code
83121
Product ID
83121-001_eea139e1-95b7-dd04-e053-2995a90a1965
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil 5%
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Securemedical, Inc.
Application
ANDA076239
Marketing category
ANDA
Marketing start
2022-11-29
Marketing end
0000-00-00
Substance
MINOXIDIL
Active strength
5 g/100mL
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83121-001-012024-01-30C16284748780-11030e365-5ce0-111a-e063-dadaa90a10e2Peak Body Minoxidil 5% Hair Regrowth treatment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83121-001-01Peak Body Mens Hair Regrowth Treatment3 in 1 BOXSOLUTION31
83121-001-01Peak Body Mens Hair Regrowth Treatment60 mL in 1 BOTTLESOLUTION601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83121-001PEAK BODY MENS HAIR REGROWTH TREATMENT (MINOXIDIL 5%) SOLUTION [SECUREMEDICAL, INC.]1Legacy NDC, 2 package rows20221130_eea139e1-95b6-dd04-e053-2995a90a1965.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311724minoxidil 5 % Topical SolutionPSNeea139e1-95b6-dd04-e053-2995a90a19651
311724minoxidil 50 MG/ML Topical SolutionSCDeea139e1-95b6-dd04-e053-2995a90a19651
311724minoxidil 3 GM per 60 ML Topical SolutionSYeea139e1-95b6-dd04-e053-2995a90a19651
311724minoxidil 5 % Topical SolutionSYeea139e1-95b6-dd04-e053-2995a90a19651
311724minoxidil 5 GM per 100 ML Topical SolutionSYeea139e1-95b6-dd04-e053-2995a90a19651

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83121-001-01831210001013 BOTTLE in 1 BOX (83121-001-01) > 60 mL in 1 BOTTLE3 bottle2022-11-290000-00-00NoNoCurrent