FDA.reportPublic FDA data

Gly-Oxide

Product NDC
63029-500
11-digit product format
630290500
Labeler code
63029
Product ID
63029-500_4c198ce8-ecfe-4ea1-99b7-fcc65f6346b8
Type
HUMAN OTC DRUG
Nonproprietary name
Carbamide Peroxide
Dosage form
LIQUID
Route
ORAL
Labeler
Medtech Products Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-06-01
Substance
CARBAMIDE PEROXIDE
Active strength
100 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
Gly-Oxide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBAMIDE PEROXIDE100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
31PZ2VAU81Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
582808Internal RxNorm lookup
1048144Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
086a0b82-e947-41c9-89e7-ba06483960c9Available 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
63029-500-01Gly-Oxide15 mL in 1 BOTTLELIQUID157
63029-500-01Gly-Oxide1 in 1 CARTONLIQUID17
63029-500-02Gly-Oxide1 in 1 CARTONLIQUID17
63029-500-02Gly-Oxide60 mL in 1 BOTTLELIQUID607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63029-500-01ML - Milliliter63029-50072518b1d-ed1c-4cff-9d58-fb4d6f0b19e212015-06-09
63029-500-02ML - Milliliter63029-500c14abdc4-5469-4ed1-b6c3-f1bb27eb6c9912015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBAMIDE PEROXIDEACTIVE INGREDIENT31PZ2VAU81GLY-OXIDE (CARBAMIDE PEROXIDE) LIQUID [MEDTECH PRODUCTS INC.]2
CARBAMIDE PEROXIDEACTIVE MOIETY31PZ2VAU81GLY-OXIDE (CARBAMIDE PEROXIDE) LIQUID [MEDTECH PRODUCTS INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPGLY-OXIDE (CARBAMIDE PEROXIDE) LIQUID [MEDTECH PRODUCTS INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXGLY-OXIDE (CARBAMIDE PEROXIDE) LIQUID [MEDTECH PRODUCTS INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GLY-OXIDE (CARBAMIDE PEROXIDE) LIQUID [MEDTECH PRODUCTS INC.]2
SODIUM LAUROYL SARCOSINATEINACTIVE INGREDIENT632GS99618GLY-OXIDE (CARBAMIDE PEROXIDE) LIQUID [MEDTECH PRODUCTS INC.]2
SODIUM STANNATEINACTIVE INGREDIENTNJ7C1V83KGGLY-OXIDE (CARBAMIDE PEROXIDE) LIQUID [MEDTECH PRODUCTS INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RGLY-OXIDE (CARBAMIDE PEROXIDE) LIQUID [MEDTECH PRODUCTS INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63029-500GLY-OXIDE (CARBAMIDE PEROXIDE) LIQUID [MEDTECH PRODUCTS INC.]7Current NDC, Legacy NDC, 4 package rows20241101_086a0b82-e947-41c9-89e7-ba06483960c9.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 · 782 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
ORCA Pain Reliever Putty with MentholMENTHOLORCA Products, LLC188cb01a-3d0f-43d9-983e-6475c0c5b06e2023-11-10WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC33fbdbc7-e10d-4181-926f-9b591b5b07e32023-11-08WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC0d2c8c0c-4c72-4400-b3b5-ed578fa351672023-11-08WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDEDegasa, S.A. de C.V.45ac0275-4c68-3897-e054-00144ff8d46c2023-11-05WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
582808carbamide peroxide 10 % Mucous Membrane Topical SolutionPSN086a0b82-e947-41c9-89e7-ba06483960c97
1048144Gly-Oxide Oral Cleanser 10 % Mucous Membrane Topical SolutionPSN086a0b82-e947-41c9-89e7-ba06483960c97
1048144carbamide peroxide 100 MG/ML Mucous Membrane Topical Solution [Gly-Oxide]SBD086a0b82-e947-41c9-89e7-ba06483960c97
582808carbamide peroxide 100 MG/ML Mucous Membrane Topical SolutionSCD086a0b82-e947-41c9-89e7-ba06483960c97
582808carbamide peroxide 10 % Mucous Membrane Topical SolutionSY086a0b82-e947-41c9-89e7-ba06483960c97
1048144Gly-Oxide 100 MG/ML Mucous Membrane Topical SolutionSY086a0b82-e947-41c9-89e7-ba06483960c97
1048144Glyoxide 10 % Mucous Membrane Topical SolutionSY086a0b82-e947-41c9-89e7-ba06483960c97

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63029-500-01630290500011 BOTTLE in 1 CARTON (63029-500-01) / 15 mL in 1 BOTTLE1 bottle2012-06-010000-00-00NoNoCurrent
63029-500-02630290500021 BOTTLE in 1 CARTON (63029-500-02) / 60 mL in 1 BOTTLE1 bottle2012-06-010000-00-00NoNoCurrent