KOLORZ TOPICAL ANESTHETIC

Product NDC: 25047-751
11-digit product format: 250470751
Labeler code: 25047
Product ID: 25047-751_0cfa1933-ee1f-4b02-84e2-64c6e31fd29a
Type: HUMAN OTC DRUG
Nonproprietary name: Benzocaine
Dosage form: GEL
Route: DENTAL
Labeler: DMG AMERICA, LLC
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-09-06
Substance: BENZOCAINE
Active strength: 200 mg/g
Pharmacologic classes: Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
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: KOLORZ TOPICAL ANESTHETIC
Brand name suffix: TRIPLE MINT
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZOCAINE	200 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
U3RSY48JW5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
238910	Internal RxNorm lookup
856886	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
0f90b227-f938-4e1a-a79e-1967b1a0477e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
25047-751-01	KOLORZ TOPICAL ANESTHETICTRIPLE MINT	29.6 g in 1 BOTTLE	GEL	29.6		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
25047-751	KOLORZ TOPICAL ANESTHETIC TRIPLE MINT (BENZOCAINE) GEL KOLORZ TOPICAL ANESTHETIC CHERRY BURST (BENZOCAINE) GEL KOLORZ TOPICAL ANESTHETIC COTTON CANDY (BENZOCAINE) GEL KOLORZ TOPICAL ANESTHETIC BLUE RASBERRY (BENZOCAINE) GEL KOLORZ TOPICAL ANESTHETIC PINA COLADA (BENZOCAINE) GEL [DMG AMERICA, LLC]	3	Current NDC, Legacy NDC, 1 package rows	20241124_0f90b227-f938-4e1a-a79e-1967b1a0477e.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 8 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sore Mouth Cleanser	HYDROGEN PEROXIDE	Meijer, Inc.	c9c17224-9304-403a-b6a1-9c8bd94e3d94	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M022
AQUAFRESH CAVITY PROTECTION	SODIUM FLUORIDE	Haleon US Holdings LLC	5484999c-8e6f-430d-99a5-6893a2489467	2026-02-16	Warnings	Exact identifier application number: M022
AQUAFRESH EXTREME CLEAN WHITENING ACTION	SODIUM FLUORIDE	Haleon US Holdings LLC	aaff19d9-4ba5-462a-893b-7220feb25d6c	2026-02-16	Warnings	Exact identifier application number: M022
Oral Sore Antiseptic	HYDROGEN PEROXIDE, MENTHOL	Walgreen Co.	55807b18-42ed-45a7-845e-fcf7f5d70d04	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: m022
Sore Mouth Cleanser	HYDROGEN PEROXIDE	Walgreen Co.	33223589-4ff4-4e4e-96da-6fa2e4d0f187	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: M022
PERIOSCIENCES SENSITIVE AO Pro	POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE	PERIOSCIENCES LLC	acca8964-b575-468c-8b40-514dfbf50778	2026-02-09	Warnings	Exact identifier application number: M022
Oral Sore Antiseptic	HYDROGEN PEROXIDE, MENTHOL	Retail Business Services, LLC	d46546d0-c6df-431a-8ab0-bc5013c084d7	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M022
Hydrogen Peroxide 3 Percent	HYDROGEN PEROXIDE	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	e19228e9-6f87-456e-a222-f979a234d589	2026-02-06	Warnings	Exact identifier application number: M022
Listerine UltraClean Plus Whitening Protection Intense Antiseptic Antigingivitis/ Antiplaque Mouthwash	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Kenvue Brands LLC	49d28991-b68f-ba16-e063-6394a90a0b13	2026-02-02	Warnings	Exact identifier application number: M022
Sootheez Strawberry Lemonade	PECTIN	Primrose Candy Co.	49e2b303-1018-cd13-e063-6394a90ae300	2026-02-02	Warnings	Exact identifier application number: M022
Sootheez Berry Lemonade	PECTIN	Primrose Candy Co.	49cee56f-c45f-6c79-e063-6294a90a5f8f	2026-02-01	Warnings	Exact identifier application number: M022
Sore Mouth Cleanser	HYDROGEN PEROXIDE	Rite Aid Corporation	294418aa-640d-42be-ad07-de31da7a7ccc	2026-01-30	Warnings, Adverse reactions	Exact identifier application number: M022
Ora YoGu 4X Medicated Tooth and Gum Pain Reliever	MEDICATED TOOTH AND GUM PAIN RELIEVER	Kungpo Health Care & Herbal Center Inc	aa61ce6f-8336-4071-93b8-549fd22d1ae0	2026-01-22	Warnings	Exact identifier application number: M022
Colgate Sensitive Complete Protection	POTASSIUM NITRATE AND SODIUM FLUORIDE	Colgate-Palmolive Company	866067b9-3dce-492d-ae99-1b807ecd56ff	2026-01-22	Warnings	Exact identifier application number: M022
Family Wellness Pain Relief	BENZOCAINE 20%	FAMILY DOLLAR (Family Wellness)	92fa0693-fca5-4bf9-8fce-a2d7e9ca37ea	2026-01-21	Warnings	Exact identifier application number: M022
Crest Pro-Health All Day Clean Breath	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	48eaca4c-19c2-2dd2-e063-6394a90a3e08	2026-01-21	Warnings	Exact identifier application number: M022
Betadine Gargle	POVIDONE-IODINE	Atlantis Consumer Healthcare, Inc.	5f0a3377-1398-2603-c632-f0d214bb88ec	2026-01-21	Warnings	Exact identifier application number: M022
ORAL PAIN RELIEF	BENZOCAINE	Universal Distribution Center LLC	e276ba37-46fb-4ed9-9ee1-c08a2a89704a	2026-01-20	Warnings	Exact identifier application number: M022
Equate Orasol	20% BENZOCAINE	WAL-MART STORES INC.	08404780-8252-4484-b1c3-8970803f74f8	2026-01-19	Warnings	Exact identifier application number: M022
Equate Healthy Mouth	CPC 0.05% ANTIPLAQUE/ANTI-GINGIVITIS	Walmart, Inc.	1cc1f6fd-67d4-b314-e063-6294a90ab995	2026-01-19	Warnings	Exact identifier application number: M022

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U3RSY48JW5	BENZOCAINE	94-09-7	BENZOCAINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
238910	benzocaine 20 % Oral Gel	PSN	0f90b227-f938-4e1a-a79e-1967b1a0477e	3
856886	Kolorz Anesthetic 20 % Oral Gel	PSN	0f90b227-f938-4e1a-a79e-1967b1a0477e	3
856886	benzocaine 0.2 MG/MG Oral Gel [Kolorz Anesthetic]	SBD	0f90b227-f938-4e1a-a79e-1967b1a0477e	3
238910	benzocaine 0.2 MG/MG Oral Gel	SCD	0f90b227-f938-4e1a-a79e-1967b1a0477e	3
238910	benzocaine 20 % (180-220 MG per 1 GM) Oral Gel	SY	0f90b227-f938-4e1a-a79e-1967b1a0477e	3
856886	Kolorz Anesthetic 0.2 MG/MG Oral Gel	SY	0f90b227-f938-4e1a-a79e-1967b1a0477e	3
856886	Kolorz Anesthetic 20 % Oral Gel	SY	0f90b227-f938-4e1a-a79e-1967b1a0477e	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
25047-751-01	25047075101	29.6 g in 1 BOTTLE (25047-751-01)	29.6 g	2019-09-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
KOLORZ ® TOPICAL ANESTHETIC	DMG AMERICA, LLC \| Medical Products Laboratories, Inc.	2021-10-01	HUMAN OTC DRUG LABEL	3