Royal Mouthwash Fresh and Clean Original Mint

Product NDC
50438-304
11-digit product format
504380304
Labeler code
50438
Product ID
50438-304_1dd6b65e-11df-4ec2-93af-70888a53b1b1
Type
HUMAN OTC DRUG
Nonproprietary name
EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL
Dosage form
LIQUID
Route
ORAL
Labeler
Filo America
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-09-17
Marketing end
0000-00-00
Substance
EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL
Active strength
1 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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
50438-304-012020-01-31C16284748780-19d75b9d1-0756-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50438-304-01Royal Mouthwash Fresh and Clean Original Mint1000 mL in 1 BOTTLE, PLASTICLIQUID10001

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EUCALYPTOLACTIVE INGREDIENTRV6J6604TKROYAL MOUTHWASH FRESH AND CLEAN ORIGINAL MINT (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [FILO AMERICA]1
MENTHOLACTIVE INGREDIENTL7T10EIP3AROYAL MOUTHWASH FRESH AND CLEAN ORIGINAL MINT (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [FILO AMERICA]1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YROYAL MOUTHWASH FRESH AND CLEAN ORIGINAL MINT (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [FILO AMERICA]1
THYMOLACTIVE INGREDIENT3J50XA376EROYAL MOUTHWASH FRESH AND CLEAN ORIGINAL MINT (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [FILO AMERICA]1
EUCALYPTOLACTIVE MOIETYRV6J6604TKROYAL MOUTHWASH FRESH AND CLEAN ORIGINAL MINT (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [FILO AMERICA]1
MENTHOLACTIVE MOIETYL7T10EIP3AROYAL MOUTHWASH FRESH AND CLEAN ORIGINAL MINT (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [FILO AMERICA]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZROYAL MOUTHWASH FRESH AND CLEAN ORIGINAL MINT (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [FILO AMERICA]1
THYMOLACTIVE MOIETY3J50XA376EROYAL MOUTHWASH FRESH AND CLEAN ORIGINAL MINT (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [FILO AMERICA]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MROYAL MOUTHWASH FRESH AND CLEAN ORIGINAL MINT (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [FILO AMERICA]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMROYAL MOUTHWASH FRESH AND CLEAN ORIGINAL MINT (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [FILO AMERICA]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDROYAL MOUTHWASH FRESH AND CLEAN ORIGINAL MINT (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [FILO AMERICA]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MROYAL MOUTHWASH FRESH AND CLEAN ORIGINAL MINT (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [FILO AMERICA]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ROYAL MOUTHWASH FRESH AND CLEAN ORIGINAL MINT (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [FILO AMERICA]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYROYAL MOUTHWASH FRESH AND CLEAN ORIGINAL MINT (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [FILO AMERICA]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUROYAL MOUTHWASH FRESH AND CLEAN ORIGINAL MINT (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [FILO AMERICA]1
SORBITOLINACTIVE INGREDIENT506T60A25RROYAL MOUTHWASH FRESH AND CLEAN ORIGINAL MINT (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [FILO AMERICA]1
WATERINACTIVE INGREDIENT059QF0KO0RROYAL MOUTHWASH FRESH AND CLEAN ORIGINAL MINT (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [FILO AMERICA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50438-304ROYAL MOUTHWASH FRESH AND CLEAN ORIGINAL MINT (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [FILO AMERICA]1Legacy NDC, 1 package rows20130917_3830dc3a-98f7-4b56-b3ae-281bb24e2e1f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashPSN3830dc3a-98f7-4b56-b3ae-281bb24e2e1f1
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD3830dc3a-98f7-4b56-b3ae-281bb24e2e1f1
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY3830dc3a-98f7-4b56-b3ae-281bb24e2e1f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
50438-304-01504380304011000 mL in 1 BOTTLE, PLASTIC1000 mlHistorical