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#

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 16 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GuruNanda OxyfusionHYDROGEN PEROXIDEGURUNANDA, LLC3be317b9-a5d8-b198-e063-6394a90af9852025-11-11WarningsExact identifier
application number: M022
GuruNanda Oral Pain ReliefMENTHOLGURUNANDA, LLC3b8f3562-0e46-bea4-e063-6294a90adb712025-11-11WarningsExact identifier
application number: M022
TopCare Cherry FlavorPHENOLTOPCO ASSOCIATES, LLC5d3f0610-deb4-4180-ae19-2c65ed2f368b2025-11-10WarningsExact identifier
application number: M022
Topcare Sore Throat Menthol FlavorPHENOLTOPCO ASSOCIATES LLCfb1f2c11-2508-4985-bae5-7d547bd6aa232025-11-10WarningsExact identifier
application number: M022
Zilactin-BBENZOCAINEASCENT CONSUMER PRODUCTS, INC42eeb3d4-bac6-4e29-e063-6294a90a644d2025-11-06WarningsExact identifier
application number: M022
Zilactin Early Relief Cold SoreBENZYL ALCOHOLASCENT CONSUMER PRODUCTS, INC42ef8bfa-c4d9-01cf-e063-6394a90ac88a2025-11-06WarningsExact identifier
application number: M022
HurriCaine Topical Anesthetic GelBENZOCAINEBeutlich Pharmaceuticals, LLC106b6115-d043-4050-80c6-1d82456dea022025-11-06WarningsExact identifier
application number: M022
HurriCaine Topical Anesthetic GelBENZOCAINEBeutlich Pharmaceuticals, LLC4c278122-2643-46bf-9e44-11985210a16e2025-11-06WarningsExact identifier
application number: M022
HurriCaine Topical Anesthetic LiquidBENZOCAINEBeutlich Pharmaceuticals, LLCfee9969d-ad1a-4f44-9741-a0a44c9e11282025-11-06WarningsExact identifier
application number: M022
Ear Wax Removal Aid DropsCARBAMIDE PEROXIDETarget Corporation0ddf9945-147d-4b25-98a6-4e9f12a4656f2025-11-05WarningsExact identifier
application number: M022
Alpha-Caine Topical AnestheticBENZOCAINEDental Technologies, Inc.e6a312e5-17ac-46f0-8723-4e40eeecd69f2025-11-04WarningsExact identifier
application number: M022
PEROXY SHIELD MOUTH SORE1.5% HYDROGEN PEROXIDEDental Technologies, Inc.a72e433b-1b7d-4a0c-e053-2995a90a30c42025-11-04WarningsExact identifier
application number: M022
Alpha-Caine Topical AnestheticBENZOCAINEDental Technologies, Inc.ae628766-25b7-4b4f-abb8-a43faf2f44b92025-11-04WarningsExact identifier
application number: M022
Alpha-Caine Topical AnestheticBENZOCAINEDental Technologies, Inc.719743f9-21fc-4568-b879-acdfa46394642025-11-04WarningsExact identifier
application number: M022
Alpha-Caine Topical AnestheticBENZOCAINEDental Technologies, Inc.ff0695a1-1d7d-4b51-97fd-689e56d914fe2025-11-04WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLFamily Dollar (FAMILY WELLNESS)f7edf75c-cdba-4dde-bfc5-a04af34759d32025-11-03WarningsExact identifier
application number: M022
7 Select Oral Pain Maximum Strength ReliefBENZOCAINE7-ELEVEN, INC.f170a570-1c50-4b9a-be16-9b01bf5eaa742025-10-31WarningsExact identifier
application number: M022
Oral Pain ReliefBENZOCAINE AND BENZALKONIUM CHLORIDEUniversal Distribution Center LLC18520f9b-4d35-1e9c-e063-6294a90aaa392025-10-30WarningsExact identifier
application number: M022
Iodent Oral AnalgesicBENZOCAINEUnited Exchange Corp.63902125-f8dc-0ada-e053-2991aa0a7ce52025-10-30WarningsExact identifier
application number: M022
Ear Wax Removal Aid DropsCARBAMIDE PEROXIDEBETTER LIVING BRANDS, LLC3bded237-4d2c-4b38-bedc-267fdc3741942025-10-29WarningsExact 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