Daniel Alain Extra Strength Hair Regrowth Treatment for Men

Product NDC
82545-002
11-digit product format
825450002
Labeler code
82545
Product ID
82545-002_d738eb33-5aeb-66bf-e053-2995a90a5e11
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil 5%
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Daniel Alain, Inc
Application
ANDA076239
Marketing category
ANDA
Marketing start
2022-02-04
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
82545-002-012024-01-30C16284748780-11030e365-0424-111a-e063-dadaa90a10e2Daniel Alain Men's Extra Strength 5% Minoxidil Topical Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82545-002-01Daniel Alain Extra Strength Hair Regrowth Treatment for Men60 mL in 1 BOTTLESOLUTION601
82545-002-01Daniel Alain Extra Strength Hair Regrowth Treatment for Men1 in 1 BOXSOLUTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82545-002DANIEL ALAIN EXTRA STRENGTH HAIR REGROWTH TREATMENT FOR MEN (MINOXIDIL 5%) SOLUTION [DANIEL ALAIN, INC]1Legacy NDC, 2 package rows20220205_d738eb33-5aea-66bf-e053-2995a90a5e11.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311724minoxidil 5 % Topical SolutionPSNd738eb33-5aea-66bf-e053-2995a90a5e111
311724minoxidil 50 MG/ML Topical SolutionSCDd738eb33-5aea-66bf-e053-2995a90a5e111
311724minoxidil 3 GM per 60 ML Topical SolutionSYd738eb33-5aea-66bf-e053-2995a90a5e111
311724minoxidil 5 % Topical SolutionSYd738eb33-5aea-66bf-e053-2995a90a5e111
311724minoxidil 5 GM per 100 ML Topical SolutionSYd738eb33-5aea-66bf-e053-2995a90a5e111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82545-002-01825450002011 BOTTLE in 1 BOX (82545-002-01) > 60 mL in 1 BOTTLE1 bottle2022-02-040000-00-00NoNoCurrent