FDA.reportPublic FDA data

GuruNanda Oxyfusion

Product NDC
70708-010
11-digit product format
707080010
Labeler code
70708
Product ID
70708-010_43567bbc-b07d-b605-e063-6294a90aad78
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrogen Peroxide
Dosage form
MOUTHWASH
Route
ORAL
Labeler
GURUNANDA, LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-01
Substance
HYDROGEN PEROXIDE
Active strength
15 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
GuruNanda Oxyfusion
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROGEN PEROXIDE15 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBBX060AN9V
Rxcui358975

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70708-010-16GuruNanda Oxyfusion473 mL in 1 BOTTLEMOUTHWASH4734
70708-010-33GuruNanda Oxyfusion999 mL in 1 BOTTLEMOUTHWASH9994

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
358975hydrogen peroxide 1.5 % MouthwashPSN3be317b9-a5d8-b198-e063-6394a90af9854
358975hydrogen peroxide 15 MG/ML MouthwashSCD3be317b9-a5d8-b198-e063-6394a90af9854
358975hydrogen peroxide 1.5 % MouthwashSY3be317b9-a5d8-b198-e063-6394a90af9854

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70708-010-1670708001016473 mL in 1 BOTTLE (70708-010-16) 473 ml2025-08-01NoNoCurrent
70708-010-3370708001033999 mL in 1 BOTTLE (70708-010-33) 999 ml2025-09-01NoNoCurrent