FDA.reportPublic FDA data

Peroxyl Mouth Sore Mild Mint

Product NDC
0126-0083
11-digit product format
001260083
Labeler code
0126
Product ID
0126-0083_0df671b6-d668-41ee-935d-838a62924b58
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrogen Peroxide
Dosage form
RINSE
Route
BUCCAL
Labeler
Colgate Oral Pharmaceuticals Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-01-01
Substance
HYDROGEN PEROXIDE
Active strength
15 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0126-00830126-0083-31DDiscontinued by firm2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…

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
Peroxyl Mouth Sore Mild Mint
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROGEN PEROXIDE15 mg/mL

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
358975Internal RxNorm lookup
1727009Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b1e1b7c9-dea7-4d64-b6a8-5343f4176359Available on FDA.report

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
0126-0083-16Peroxyl Mouth Sore Mild Mint500 mL in 1 BOTTLE, PLASTICRINSE50018
0126-0083-22Peroxyl Mouth Sore Mild Mint1000 mL in 1 BOTTLERINSE100018
0126-0083-31Peroxyl Mouth Sore Mild Mint946 mL in 1 BOTTLERINSE94618
0126-0083-70Peroxyl Mouth Sore Mild Mint10 mL in 1 POUCHRINSE1018
0126-0083-70Peroxyl Mouth Sore Mild Mint50 in 1 CARTONRINSE5018
0126-0083-99Peroxyl Mouth Sore Mild Mint250 mL in 1 BOTTLE, PLASTICRINSE25018
0126-0083-70PEROXYL MOUTH SORE MILD MINT50 in 1 CARTONRINSE501
0126-0083-70PEROXYL MOUTH SORE MILD MINT10 mL in 1 POUCHRINSE101

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Hydrogen PeroxideACTIVE INGREDIENTBBX060AN9VPEROXYL MOUTH SORE MILD MINT (HYDROGEN PEROXIDE) RINSE [COLGATE ORAL PHARMACEUTICALS, INC.]1
Hydrogen PeroxideACTIVE MOIETYBBX060AN9VPEROXYL MOUTH SORE MILD MINT (HYDROGEN PEROXIDE) RINSE [COLGATE ORAL PHARMACEUTICALS, INC.]1
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDPEROXYL MOUTH SORE MILD MINT (HYDROGEN PEROXIDE) RINSE [COLGATE ORAL PHARMACEUTICALS, INC.]1
Poloxamer 338INACTIVE INGREDIENTF75JV2T505PEROXYL MOUTH SORE MILD MINT (HYDROGEN PEROXIDE) RINSE [COLGATE ORAL PHARMACEUTICALS, INC.]1
Polysorbate 20INACTIVE INGREDIENT7T1F30V5YHPEROXYL MOUTH SORE MILD MINT (HYDROGEN PEROXIDE) RINSE [COLGATE ORAL PHARMACEUTICALS, INC.]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3PEROXYL MOUTH SORE MILD MINT (HYDROGEN PEROXIDE) RINSE [COLGATE ORAL PHARMACEUTICALS, INC.]1
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TYPEROXYL MOUTH SORE MILD MINT (HYDROGEN PEROXIDE) RINSE [COLGATE ORAL PHARMACEUTICALS, INC.]1
SorbitolINACTIVE INGREDIENT506T60A25RPEROXYL MOUTH SORE MILD MINT (HYDROGEN PEROXIDE) RINSE [COLGATE ORAL PHARMACEUTICALS, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RPEROXYL MOUTH SORE MILD MINT (HYDROGEN PEROXIDE) RINSE [COLGATE ORAL PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0126-0083PEROXYL MOUTH SORE MILD MINT (HYDROGEN PEROXIDE) RINSE [COLGATE ORAL PHARMACEUTICALS INC.]18Current NDC, Legacy NDC, 6 package rows20241127_b1e1b7c9-dea7-4d64-b6a8-5343f4176359.zip
0126-0083PEROXYL MOUTH SORE MILD MINT (HYDROGEN PEROXIDE) RINSE [COLGATE ORAL PHARMACEUTICALS, INC.]1Current NDC, Legacy NDC, 2 package rows20151218_818575ec-5136-4d4f-a0d4-51a7770499be.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 38 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Moon Charcoal Whitening AnticavitySODIUM FLUORIDEMoon Oral Care, LLC0c55f7b3-fea1-58f3-e063-6394a90a3bde2023-12-12WarningsExact identifier
application number: M022
ORCA Complete Menthol Pain RelieverMENTHOLORCA Products, LLC99990e27-d66b-4d61-97f2-6a76066eb8b82023-12-08WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc0070858b-e02e-431f-a7c2-313fef01791b2023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Incd1802f08-80cb-41dd-b34d-9c576b101ddb2023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc80182c43-100f-4b15-a07e-819599ab95622023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Incc19e6426-8f1e-47b3-a3a6-551a5bec6cd92023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc1f8431bb-f33c-4fd8-9472-9b59ffb5f18e2023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc1163d248-d648-443e-bed0-ccb7fd26ba632023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc88caabe2-a096-44d0-98d3-afad1935c0122023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Incc1b02a2f-db1f-44f0-a74a-d02c085c5bd72023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc39081585-fe6a-4ba1-93f8-d92d26fe75bc2023-12-07WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.d7c69357-795c-03d8-e053-2a95a90a03a62023-12-06WarningsExact identifier
application number: M022
Dr. Sheffield Sensitive CareSENSITIVE TOOTH PASTESheffield Pharmaceuticals LLC702a0dec-64cf-4834-8d80-f3d4f0c08a3a2023-11-30WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCf3bf106c-5320-ced2-e053-2a95a90a71ac2023-11-29WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC0b517321-25ed-2676-e063-6294a90ab4c92023-11-29WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC0b51b67c-03ac-5730-e063-6394a90a50602023-11-29WarningsExact identifier
application number: M022
Pearl WhitePOTASSIUM NITRATE, SODIUM FLUORIDEBeyond International Inc.51c79544-9536-5863-e054-00144ff8d46c2023-11-28WarningsExact identifier
application number: M022
UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDEPOTASSIUM NITRATE AND SODIUM FLUORIDEUniversal Distribution Center LLCfcf59439-7e06-4129-a89f-cdeecdf8d4882023-11-17WarningsExact identifier
application number: M022
PerioRestoreHYDROGEN PEROXIDEDEN-MAT HOLDINGS, LLC.97a07c36-1af8-a636-e053-2a95a90ad6db2023-11-13WarningsExact identifier
application number: M022
Wild Horse 777 OralPHENOLWild Horse 777, Inc.b0b517bb-969f-0c65-e053-2995a90a48b12023-11-10WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
358975hydrogen peroxide 1.5 % MouthwashPSNb1e1b7c9-dea7-4d64-b6a8-5343f417635918
1727009Peroxyl 1.5 % MouthwashPSNb1e1b7c9-dea7-4d64-b6a8-5343f417635918
1727009hydrogen peroxide 15 MG/ML Mouthwash [Peroxyl]SBDb1e1b7c9-dea7-4d64-b6a8-5343f417635918
358975hydrogen peroxide 15 MG/ML MouthwashSCDb1e1b7c9-dea7-4d64-b6a8-5343f417635918
358975hydrogen peroxide 1.5 % MouthwashSYb1e1b7c9-dea7-4d64-b6a8-5343f417635918
1727009Peroxyl 1.5 % MouthwashSYb1e1b7c9-dea7-4d64-b6a8-5343f417635918
1727009Peroxyl 15 MG/ML MouthwashSYb1e1b7c9-dea7-4d64-b6a8-5343f417635918
358975hydrogen peroxide 1.5 % MouthwashPSN818575ec-5136-4d4f-a0d4-51a7770499be1
1727009Peroxyl 1.5 % MouthwashPSN818575ec-5136-4d4f-a0d4-51a7770499be1
1727009hydrogen peroxide 15 MG/ML Mouthwash [Peroxyl]SBD818575ec-5136-4d4f-a0d4-51a7770499be1
358975hydrogen peroxide 15 MG/ML MouthwashSCD818575ec-5136-4d4f-a0d4-51a7770499be1
358975hydrogen peroxide 1.5 % MouthwashSY818575ec-5136-4d4f-a0d4-51a7770499be1
1727009Peroxyl 1.5 % MouthwashSY818575ec-5136-4d4f-a0d4-51a7770499be1
1727009Peroxyl 15 MG/ML MouthwashSY818575ec-5136-4d4f-a0d4-51a7770499be1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0126-0083-1600126008316500 mL in 1 BOTTLE, PLASTIC (0126-0083-16) 500 ml2009-01-010000-00-00NoNoCurrent
0126-0083-22001260083221000 mL in 1 BOTTLE (0126-0083-22) 1000 ml2020-08-310000-00-00NoNoCurrent
0126-0083-3100126008331946 mL in 1 BOTTLE (0126-0083-31) 946 ml2020-08-290000-00-00NoNoCurrent
0126-0083-700012600837050 POUCH in 1 CARTON (0126-0083-70) / 10 mL in 1 POUCH50 pouch2017-03-150000-00-00NoNoCurrent
0126-0083-9900126008399250 mL in 1 BOTTLE, PLASTIC (0126-0083-99) 250 ml2015-01-010000-00-00NoNoCurrent