FDA.reportPublic FDA data

Control Dandruff Therapy

Product NDC
50718-0021
11-digit product format
507180021
Labeler code
50718
Product ID
50718-0021_6820d2bc-1aaf-4bca-ae9a-d1509d8f4232
Type
HUMAN OTC DRUG
Nonproprietary name
dandruff therapy shampoo
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Kamedis
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-01-01
Substance
PYRITHIONE ZINC
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Control Dandruff Therapy
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRITHIONE ZINC10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR953O2RHZ5
Rxcui209884

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50718-0021-12024-02-13C16284748780-11030e364-fd4e-111a-e063-dadaa90a10e2Control - Dandruff Therapy Shampoo
50718-0021-12024-01-30C16284748780-11030e364-fd4e-111a-e063-dadaa90a10e2Control - Dandruff Therapy Shampoo

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50718-0021-1Control Dandruff Therapy200 mL in 1 BOTTLESHAMPOO2005
50718-0021-1Control Dandruff Therapy1 in 1 CARTONSHAMPOO15
50718-0021-2Control Dandruff Therapy500 mL in 1 BOTTLESHAMPOO5005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50718-0021CONTROL DANDRUFF THERAPY (DANDRUFF THERAPY SHAMPOO) SHAMPOO [KAMEDIS]5Current NDC, Legacy NDC, 3 package rows20240213_2a5fc8ae-1d98-496c-a6ca-922897e3ab47.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
209884zinc pyrithione 1 % Medicated ShampooPSN2a5fc8ae-1d98-496c-a6ca-922897e3ab475
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD2a5fc8ae-1d98-496c-a6ca-922897e3ab475
209884zinc pyrithione 1 % Medicated ConditionerSY2a5fc8ae-1d98-496c-a6ca-922897e3ab475
209884zinc pyrithione 1 % Medicated ShampooSY2a5fc8ae-1d98-496c-a6ca-922897e3ab475

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50718-0021-1507180021011 BOTTLE in 1 CARTON (50718-0021-1) / 200 mL in 1 BOTTLE1 bottle2018-01-010000-00-00NoNoCurrent
50718-0021-250718002102500 mL in 1 BOTTLE (50718-0021-2) 500 ml2024-01-01NoNoHistorical