Prevention Mouth Sore Rinse

Product NDC
69951-004
11-digit product format
699510004
Labeler code
69951
Product ID
69951-004_2eae7404-0d19-0c00-e063-6294a90a9929
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrogen peroxide
Dosage form
LIQUID
Route
TOPICAL
Labeler
Prevention Health Sciences, Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-01
Substance
HYDROGEN PEROXIDE
Active strength
1.4 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Prevention Mouth Sore Rinse
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROGEN PEROXIDE1.4 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
BBX060AN9VInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2705805Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2eae61e4-1800-5fa6-e063-6394a90a9583Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69951-004-16Prevention Mouth Sore Rinse473 mL in 1 BOTTLE, PLASTICLIQUID4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69951-004PREVENTION MOUTH SORE RINSE (HYDROGEN PEROXIDE) LIQUID [PREVENTION HEALTH SCIENCES, INC.]1Current NDC, 1 package rows20250228_2eae61e4-1800-5fa6-e063-6394a90a9583.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 25 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Candee Caine Topical AnestheticBENZOCAINEAmerican Medical & Hospital Supply Co., Inc.0192ccf9-1715-4e23-a6bf-8bd838cd8b0d2025-01-09WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINEAmerican Medical & Hospital Supply Co., Inc.edcb8451-6fa7-4bc2-95f6-2a0806f7f3da2025-01-09WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINEAmerican Medical & Hospital Supply Co., Inc.576660ed-203a-4842-9d39-c5be10daf9762025-01-09WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINEAmerican Medical & Hospital Supply Co., Inc.1796b3ec-833a-4cf1-ba50-bc4da827f84f2025-01-09WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINEAmerican Medical & Hospital Supply Co., Inc.d923fa75-f556-45e3-9f52-39a62e89984b2025-01-09WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINEAmerican Medical & Hospital Supply Co., Inc.cd3ede8c-2c77-4d81-8dff-8198025a21562025-01-09WarningsExact identifier
application number: M022
KAYLAANZERO WASTE REFILL FOR TOOTHPASTEKaylaan LLCcb7f5f9b-4192-15e6-e053-2995a90a64572025-01-09WarningsExact identifier
application number: M022
KAYLAANZERO WASTE REFILL FOR TOOTHPASTEKaylaan LLC2b494372-de59-e462-e063-6294a90a08da2025-01-09WarningsExact identifier
application number: M022
Dental City Topical AnestheticBENZOCAINEICP Inc DBA Dental Citya225d515-430d-4e34-846c-0bfec3e741092025-01-09WarningsExact identifier
application number: M022
Dental City Topical AnestheticBENZOCAINEICP Inc DBA Dental City372f99c9-4ad3-4631-b8c8-2a34c47343cc2025-01-09WarningsExact identifier
application number: M022
Dental City Topical AnestheticBENZOCAINEICP Inc DBA Dental Citye554b5b2-cf91-464a-a930-3e1087f12c8d2025-01-09WarningsExact identifier
application number: M022
Dental City Topical AnestheticBENZOCAINEICP Inc DBA Dental City98da331c-76c2-49fe-b687-6bfba4ae2e752025-01-09WarningsExact identifier
application number: M022
Dental City Topical AnestheticBENZOCAINEICP Inc DBA Dental Cityd2195efa-597d-4ba9-a9b0-8df0d8f493112025-01-09WarningsExact identifier
application number: M022
Dental City Topical AnestheticBENZOCAINEICP Inc DBA Dental Cityfba82d55-94db-4432-b532-603fe57202be2025-01-09WarningsExact identifier
application number: M022
Dental City Topical AnestheticBENZOCAINEICP Inc DBA Dental City9ed0fe31-e5f2-4d6d-8686-1286c66598472025-01-09WarningsExact identifier
application number: M022
Dental City Topical AnestheticBENZOCAINEICP Inc DBA Dental Cityd5f42c30-343c-4e1d-950c-89bbd361fd272025-01-09WarningsExact identifier
application number: M022
Dental City Topical AnestheticBENZOCAINEICP Inc DBA Dental City7dce407f-bbe4-4a27-97ff-be33fd4474612025-01-09WarningsExact identifier
application number: M022
KAYLAANZERO WASTE REFILL FOR TOOTHPASTEKaylaan LLCcb7f28f3-a908-47a9-e053-2995a90a6cbd2025-01-09WarningsExact identifier
application number: M022
GPS Topical AnestheticBENZOCAINEGroup Practice Solutions, Inc.921bdb76-f6d3-4e0a-a0ac-277dcc4e8d282025-01-09WarningsExact identifier
application number: M022
GPS Topical AnestheticBENZOCAINEGroup Practice Solutions, Inc.a80cfd29-8314-4639-a811-afd5fdb630b02025-01-09WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2705805hydrogen peroxide 1.4 % MouthwashPSN2eae61e4-1800-5fa6-e063-6394a90a95831
2705805hydrogen peroxide 14 MG/ML MouthwashSCD2eae61e4-1800-5fa6-e063-6394a90a95831
2705805hydrogen peroxide 1.4 % MouthwashSY2eae61e4-1800-5fa6-e063-6394a90a95831

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69951-004-1669951000416473 mL in 1 BOTTLE, PLASTIC (69951-004-16) 473 ml2025-01-01NoNoCurrent