Aurora Fresh Burst

Product NDC
63148-560
11-digit product format
631480560
Labeler code
63148
Product ID
63148-560_8fd01b90-7898-451b-a3f7-aa6c8c85e476
Type
HUMAN OTC DRUG
Nonproprietary name
Eucalyptol, Menthol, Methyl Salicylate, Thymol
Dosage form
MOUTHWASH
Route
BUCCAL
Labeler
Apollo Health and Beauty Care
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2016-06-13
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
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63148-560-502024-01-30C16284748780-11030e365-1054-111a-e063-dadaa90a10e2DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63148-560-50Aurora Fresh Burst1500 mL in 1 BOTTLE, PLASTICMOUTHWASH15001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63148-560AURORA FRESH BURST (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [APOLLO HEALTH AND BEAUTY CARE]1Legacy NDC, 1 package rows20160615_ffb10843-e1f5-4efd-a88f-5e1378591d15.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 % MouthwashPSNffb10843-e1f5-4efd-a88f-5e1378591d151
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCDffb10843-e1f5-4efd-a88f-5e1378591d151
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSYffb10843-e1f5-4efd-a88f-5e1378591d151

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63148-560-50631480560501500 mL in 1 BOTTLE, PLASTIC (63148-560-50) 1500 ml2016-06-130000-00-00NoNoCurrent