Royal dandruff Dry Scalp Care

Product NDC
50438-300
11-digit product format
504380300
Labeler code
50438
Product ID
50438-300_f132d80e-721f-4219-963e-43764aaa88bf
Type
HUMAN OTC DRUG
Nonproprietary name
PYRITHIONE ZINC
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Filo America
Application
part358H
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-09-17
Marketing end
0000-00-00
Substance
PYRITHIONE ZINC
Active strength
1 g/100mL
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50438-300-012020-01-31C16284748780-19d75b9cf-d481-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50438-300-01Royal dandruff Dry Scalp Care350 mL in 1 BOTTLESHAMPOO3501

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PYRITHIONE ZINCACTIVE INGREDIENTR953O2RHZ5ROYAL DANDRUFF DRY SCALP CARE (PYRITHIONE ZINC) SHAMPOO [FILO AMERICA]1
PYRITHIONE ZINCACTIVE MOIETYR953O2RHZ5ROYAL DANDRUFF DRY SCALP CARE (PYRITHIONE ZINC) SHAMPOO [FILO AMERICA]1
ammonium chlorideINACTIVE INGREDIENT01Q9PC255DROYAL DANDRUFF DRY SCALP CARE (PYRITHIONE ZINC) SHAMPOO [FILO AMERICA]1
CARBOMER COPOLYMER TYPE AINACTIVE INGREDIENT71DD5V995LROYAL DANDRUFF DRY SCALP CARE (PYRITHIONE ZINC) SHAMPOO [FILO AMERICA]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPROYAL DANDRUFF DRY SCALP CARE (PYRITHIONE ZINC) SHAMPOO [FILO AMERICA]1
cocamidopropyl betaineINACTIVE INGREDIENT5OCF3O11KXROYAL DANDRUFF DRY SCALP CARE (PYRITHIONE ZINC) SHAMPOO [FILO AMERICA]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KROYAL DANDRUFF DRY SCALP CARE (PYRITHIONE ZINC) SHAMPOO [FILO AMERICA]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDROYAL DANDRUFF DRY SCALP CARE (PYRITHIONE ZINC) SHAMPOO [FILO AMERICA]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MROYAL DANDRUFF DRY SCALP CARE (PYRITHIONE ZINC) SHAMPOO [FILO AMERICA]1
glycol stearateINACTIVE INGREDIENT0324G66D0EROYAL DANDRUFF DRY SCALP CARE (PYRITHIONE ZINC) SHAMPOO [FILO AMERICA]1
methylchloroisothiazolinoneINACTIVE INGREDIENTDEL7T5QRPNROYAL DANDRUFF DRY SCALP CARE (PYRITHIONE ZINC) SHAMPOO [FILO AMERICA]1
methylisothiazolinoneINACTIVE INGREDIENT229D0E1QFAROYAL DANDRUFF DRY SCALP CARE (PYRITHIONE ZINC) SHAMPOO [FILO AMERICA]1
waterINACTIVE INGREDIENT059QF0KO0RROYAL DANDRUFF DRY SCALP CARE (PYRITHIONE ZINC) SHAMPOO [FILO AMERICA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50438-300ROYAL DANDRUFF DRY SCALP CARE (PYRITHIONE ZINC) SHAMPOO [FILO AMERICA]1Legacy NDC, 1 package rows20130917_73ea659a-e1c3-4f0e-aa7e-e4c8342e06a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
209884zinc pyrithione 1 % Medicated ShampooPSN73ea659a-e1c3-4f0e-aa7e-e4c8342e06a31
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD73ea659a-e1c3-4f0e-aa7e-e4c8342e06a31
209884zinc pyrithione 1 % Medicated ConditionerSY73ea659a-e1c3-4f0e-aa7e-e4c8342e06a31
209884zinc pyrithione 1 % Medicated ShampooSY73ea659a-e1c3-4f0e-aa7e-e4c8342e06a31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
50438-300-0150438030001350 mL in 1 BOTTLE350 mlHistorical