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
Ingredient	Strength
CARBAMIDE PEROXIDE	100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
31PZ2VAU81	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
086a0b82-e947-41c9-89e7-ba06483960c9	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5eb9f24b-9328-475e-af0a-18021935eb6a	Product name	1	20180220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63029-500-01	Gly-Oxide	15 mL in 1 BOTTLE	LIQUID	15	7
63029-500-01	Gly-Oxide	1 in 1 CARTON	LIQUID	1	7
63029-500-02	Gly-Oxide	1 in 1 CARTON	LIQUID	1	7
63029-500-02	Gly-Oxide	60 mL in 1 BOTTLE	LIQUID	60	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63029-500-01	ML - Milliliter	63029-500	72518b1d-ed1c-4cff-9d58-fb4d6f0b19e2	1	2015-06-09
63029-500-02	ML - Milliliter	63029-500	c14abdc4-5469-4ed1-b6c3-f1bb27eb6c99	1	2015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CARBAMIDE PEROXIDE	ACTIVE INGREDIENT	31PZ2VAU81	GLY-OXIDE (CARBAMIDE PEROXIDE) LIQUID [MEDTECH PRODUCTS INC.]	2
CARBAMIDE PEROXIDE	ACTIVE MOIETY	31PZ2VAU81	GLY-OXIDE (CARBAMIDE PEROXIDE) LIQUID [MEDTECH PRODUCTS INC.]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	GLY-OXIDE (CARBAMIDE PEROXIDE) LIQUID [MEDTECH PRODUCTS INC.]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	GLY-OXIDE (CARBAMIDE PEROXIDE) LIQUID [MEDTECH PRODUCTS INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	GLY-OXIDE (CARBAMIDE PEROXIDE) LIQUID [MEDTECH PRODUCTS INC.]	2
SODIUM LAUROYL SARCOSINATE	INACTIVE INGREDIENT	632GS99618	GLY-OXIDE (CARBAMIDE PEROXIDE) LIQUID [MEDTECH PRODUCTS INC.]	2
SODIUM STANNATE	INACTIVE INGREDIENT	NJ7C1V83KG	GLY-OXIDE (CARBAMIDE PEROXIDE) LIQUID [MEDTECH PRODUCTS INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	GLY-OXIDE (CARBAMIDE PEROXIDE) LIQUID [MEDTECH PRODUCTS INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63029-500	GLY-OXIDE (CARBAMIDE PEROXIDE) LIQUID [MEDTECH PRODUCTS INC.]	7	Current NDC, Legacy NDC, 4 package rows	20241101_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 34 of 40 · 782 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Orajel 2X Medicated Gel	ORAL PAIN RELIEVER	Church & Dwight Co., Inc.	262be295-4eaf-3136-e063-6294a90a7dcc	2024-11-05	Warnings	Exact identifier application number: M022
BIOTENE Fresh Mint Original	SODIUM FLUORIDE	Haleon US Holdings LLC	1101c17f-c848-4cd5-a7cd-679b59dbe1bf	2024-11-05	Warnings	Exact identifier application number: M022
biotene	SODIUM MONOFLUOROPHOSPHATE	Haleon US Holdings LLC	a47a6502-efb2-4072-9562-cbe293531c2b	2024-11-04	Warnings	Exact identifier application number: M022
Amosan Oral Wound Cleanser Cherry	SODIUM PERBORATE MONOHYDRATE	Vintage Brands Limited	a0e145c8-6b08-40be-ae4f-5678c4a78b1e	2024-10-30	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	043bfbc3-c33b-78b7-e063-6294a90a1a5a	2024-10-29	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	043bfbc3-c33a-78b7-e063-6294a90a1a5a	2024-10-29	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	043a3cb4-f560-0ffd-e063-6394a90a2ff6	2024-10-29	Warnings	Exact identifier application number: M022
Amosan Oral Wound Cleanser Mint	SODIUM PERBORATE MONOHYDRATE	Vintage Brands Limited	be57ca56-834f-4170-a407-f193484d8b0a	2024-10-29	Warnings	Exact identifier application number: M022
SENSODYNE PRONAMEL Intensive Enamel Repair Clean Mint	SODIUM FLUORIDE	Haleon US Holdings LLC	817c0dad-d109-428e-adb5-3354604acc94	2024-10-28	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	1f3d68f6-afd6-42e7-b3e5-210228c8e7de	2024-10-28	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals LLC	0dd15227-6603-42ac-9a5f-f2dc49e0382a	2024-10-28	Warnings, Adverse reactions	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	0605d5d6-82bd-415e-b5cb-e273f934a4a7	2024-10-28	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic Liquid	BENZOCAINE	Beutlich Pharmaceuticals, LLC	f70fa3fc-cd65-4a80-9efd-129e98fd3998	2024-10-28	Warnings	Exact identifier application number: M022
Sore Throat Relief Menthol	PHENOL	Chain Drug Consortium	af661ef0-cdc3-4146-8ae5-59795aa49650	2024-10-28	Warnings	Exact identifier application number: M022
Sore Throat Relief Cherry Flavor	PHENOL	Chain Drug Consortium	a9cf9829-4b70-44fa-9719-240b65c06724	2024-10-28	Warnings	Exact identifier application number: M022
Ear Wax Removal Aid Drops	CARBAMIDE PEROXIDE	PHARMACY VALUE ALLIANCE, LLC	85ae80c1-2bc2-4c90-9559-63510d03e739	2024-10-28	Warnings	Exact identifier application number: M022
Chloraspetic	MENTHOL AND BENZOCAINE	Prestige Brands Holdings, Inc.	2b1808b2-2574-4ab8-a762-5733251848ce	2024-10-25	Warnings	Exact identifier application number: M022
Chloraseptic Warming Sore Throat	PHENOL	Prestige Brands Holdings, Inc.	a197fab2-70ce-4a6c-9add-29d7368a75c5	2024-10-25	Warnings	Exact identifier application number: M022
Gly-Oxide	CARBAMIDE PEROXIDE	Medtech Products Inc.	086a0b82-e947-41c9-89e7-ba06483960c9	2024-10-25	Warnings	Exact identifier application number: M022 ndc (product): 63029-500
CHLORASEPTIC	MENTHOL AND BENZOCAINE	Prestige Brands Holdings, Inc.	d500f423-b9f2-4d98-8f2a-8bab7c05737c	2024-10-25	Warnings	Exact identifier application number: M022

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
31PZ2VAU81	CARBAMIDE PEROXIDE	124-43-6	CARBAMIDE PEROXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
582808	carbamide peroxide 10 % Mucous Membrane Topical Solution	PSN	086a0b82-e947-41c9-89e7-ba06483960c9	7
1048144	Gly-Oxide Oral Cleanser 10 % Mucous Membrane Topical Solution	PSN	086a0b82-e947-41c9-89e7-ba06483960c9	7
1048144	carbamide peroxide 100 MG/ML Mucous Membrane Topical Solution [Gly-Oxide]	SBD	086a0b82-e947-41c9-89e7-ba06483960c9	7
582808	carbamide peroxide 100 MG/ML Mucous Membrane Topical Solution	SCD	086a0b82-e947-41c9-89e7-ba06483960c9	7
582808	carbamide peroxide 10 % Mucous Membrane Topical Solution	SY	086a0b82-e947-41c9-89e7-ba06483960c9	7
1048144	Gly-Oxide 100 MG/ML Mucous Membrane Topical Solution	SY	086a0b82-e947-41c9-89e7-ba06483960c9	7
1048144	Glyoxide 10 % Mucous Membrane Topical Solution	SY	086a0b82-e947-41c9-89e7-ba06483960c9	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63029-500-01	63029050001	1 BOTTLE in 1 CARTON (63029-500-01) / 15 mL in 1 BOTTLE	1 bottle	2012-06-01	0000-00-00	No	No	Current
63029-500-02	63029050002	1 BOTTLE in 1 CARTON (63029-500-02) / 60 mL in 1 BOTTLE	1 bottle	2012-06-01	0000-00-00	No	No	Current