Gel-Kam Mint

Product NDC: 0126-0192
11-digit product format: 001260192
Labeler code: 0126
Product ID: 0126-0192_d11d1acf-71a3-433a-8845-31d9a40bdfbd
Type: HUMAN OTC DRUG
Nonproprietary name: Stannous Fluoride
Dosage form: GEL, DENTIFRICE
Route: DENTAL
Labeler: Colgate Oral Pharmaceuticals, Inc.
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1990-01-01
Substance: STANNOUS FLUORIDE
Active strength: 1 mg/g
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: Gel-Kam Mint
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
STANNOUS FLUORIDE	1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3FTR44B32Q	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
237847	Internal RxNorm lookup
750088	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
8c2c3c5c-ddef-4a4d-8bc3-5a98c577e74c	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0126-0192-93	Gel-Kam Mint	122 g in 1 TUBE	GEL, DENTIFRICE	122		13
0126-0192-93	Gel-Kam Mint	1 in 1 CARTON	GEL, DENTIFRICE	1		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0126-0192-93	GM - Gram	0126-0192	2f391b90-6296-499e-97e3-27ef5272ce95	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Stannous Fluoride	ACTIVE INGREDIENT	3FTR44B32Q	GEL-KAM MINT (STANNOUS FLUORIDE) GEL, DENTIFRICE GEL-KAM FRUIT AND BERRY (STANNOUS FLUORIDE) GEL, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.]	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	GEL-KAM MINT (STANNOUS FLUORIDE) GEL, DENTIFRICE GEL-KAM FRUIT AND BERRY (STANNOUS FLUORIDE) GEL, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.]	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	GEL-KAM MINT (STANNOUS FLUORIDE) GEL, DENTIFRICE GEL-KAM FRUIT AND BERRY (STANNOUS FLUORIDE) GEL, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.]	1
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)	INACTIVE INGREDIENT	S38J6RZN16	GEL-KAM MINT (STANNOUS FLUORIDE) GEL, DENTIFRICE GEL-KAM FRUIT AND BERRY (STANNOUS FLUORIDE) GEL, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0126-0192	GEL-KAM MINT (STANNOUS FLUORIDE) GEL, DENTIFRICE GEL-KAM FRUIT AND BERRY (STANNOUS FLUORIDE) GEL, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.]	13	Current NDC, Legacy NDC, 2 package rows	20240119_8c2c3c5c-ddef-4a4d-8bc3-5a98c577e74c.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 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CURODONT REPAIR FLUORIDE PLUS	SODIUM FLUORIDE	CREDENTIS AG	290c57b0-a562-0a51-e063-6294a90a0720	2025-06-23	Warnings	Exact identifier application number: M021
KarlnHans Fresh Breath Jasmine Mint	SODIUM MONOFLUOROPHOSPHATE	PIGEON CORPORATION	384863bd-b2cb-a46d-e063-6394a90a3ce2	2025-06-23	Warnings	Exact identifier application number: M021
KarlnHans Fresh Breath Double Mint	SODIUM MONOFLUOROPHOSPHATE	PIGEON CORPORATION	38487130-9508-a2c4-e063-6394a90aa323	2025-06-23	Warnings	Exact identifier application number: M021
Crest Kids SparkleFun Bubblegum	SODIUM FLUORIDE	Procter & Gamble Manufactura, S. de R.L. de C.V.	01f0e81a-03bf-e17f-e063-6394a90a7358	2025-06-12	Warnings	Exact identifier application number: M021
Freshen Up	SODIUM FLUORIDE, POTASSIUM NITRATE	MKJ BRANDS LLC	2ee626d1-6150-87db-e063-6294a90a64d8	2025-06-12	Warnings	Exact identifier application number: M021
Colgate MaxFresh Citrus Fresh	SODIUM FLUORIDE	Colgate-Palmolive Company	13a74642-51d2-493c-ae97-a54508546a74	2025-06-12	Warnings	Exact identifier application number: M021
Colgate MaxFresh Watermelon Blast	SODIUM FLUORIDE	Colgate-Palmolive Company	4f07f945-6594-40f4-bc19-6acc12c37cdd	2025-06-12	Warnings	Exact identifier application number: M021
Euthymol Whitening	SODIUM FLUORIDE	LG HOUSEHOLD & HEALTH CARE LTD.	36994628-e5f3-3c35-e063-6294a90a609d	2025-06-02	Warnings	Exact identifier application number: M021
EUTHYMOL WHITENING SPECIAL GIFT SET	SODIUM FLUORIDE	LG HOUSEHOLD & HEALTH CARE LTD.	35bfa3fc-106e-aecc-e063-6294a90a7eb0	2025-05-22	Warnings	Exact identifier application number: M021
EUTHYMOL WHITENING GIFT SET (40gX3)	SODIUM FLUORIDE	LG HOUSEHOLD & HEALTH CARE LTD.	369aa02f-c312-6a0d-e063-6294a90adaa5	2025-05-22	Warnings	Exact identifier application number: M021
EUTHYMOL WHITENING TRAVEL	SODIUM FLUORIDE	LG HOUSEHOLD & HEALTH CARE LTD.	3596306e-858c-9bf7-e063-6294a90ac1d6	2025-05-20	Warnings	Exact identifier application number: M021
Euthymol Whitening	SODIUM FLUORIDE	LG HOUSEHOLD & HEALTH CARE LTD.	3582cc91-8c32-9f93-e063-6394a90a8792	2025-05-19	Warnings	Exact identifier application number: M021
EUTHYMOL WHITENING SET	SODIUM FLUORIDE	LG HOUSEHOLD & HEALTH CARE LTD.	35839b10-4c40-40e5-e063-6294a90a85b4	2025-05-19	Warnings	Exact identifier application number: M021
Hello Unicorn Sparkle	SODIUM FLUORIDE	Colgate-Palmolive Company	5acfbd9b-278c-24dd-8041-5e2cdffbf710	2025-05-13	Warnings	Exact identifier application number: M021
Optimax Anticavity Fluoride Cotton Candy	SODIUM MONOFLUOROPHOSPHATE	WHITE GLO USA INC	25f182cb-ad1e-4c13-bc79-1ec251754cf8	2025-05-12	Warnings	Exact identifier application number: M021
Optimax Anticavity Fluoride Watermelon	SODIUM MONOFLUOROPHOSPHATE	WHITE GLO USA INC	b506df13-649f-4615-bc25-6ae08bd56b18	2025-05-12	Warnings	Exact identifier application number: M021
Listerine Total Care Alcohol Free Anticavity Fluoride Mouthwash Fresh Mint	SODIUM FLUORIDE	Kenvue Brands LLC	346daeae-7590-176c-e063-6294a90a52ea	2025-05-05	Warnings	Exact identifier application number: M021
Evo Sensitive Whitening Anti-cavity Fluoride Mouthwash	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD.	3de0d71a-7704-97dd-e063-6294a90a5d2c	2025-05-01	Warnings	Exact identifier application number: M021
Brush Buddies Value 2 pack Whitening	SODIUM MONOFLUOROPHOSPHATE	Ashtel Studios, Inc	636bf51d-9750-4305-ab4a-3483c9f0169b	2025-04-30	Warnings	Exact identifier application number: M021
Handy Solutions Crest Complete MULTI-BENEFIT WHITENING plus Scope	SODIUM FLUORIDE	Navajo Manufacturing Company Inc	3adb1524-0fd6-4728-b757-dcbda4cdd0fb	2025-04-29	Warnings	Exact identifier application number: M021

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3FTR44B32Q	STANNOUS FLUORIDE	7783-47-3	STANNOUS FLUORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
750088	Gel-Kam 0.4 % Oral Gel	PSN	8c2c3c5c-ddef-4a4d-8bc3-5a98c577e74c	13
237847	stannous fluoride 0.4 % Oral Gel	PSN	8c2c3c5c-ddef-4a4d-8bc3-5a98c577e74c	13
750088	stannous fluoride 0.004 MG/MG Oral Gel [Gel-Kam]	SBD	8c2c3c5c-ddef-4a4d-8bc3-5a98c577e74c	13
237847	stannous fluoride 0.004 MG/MG Oral Gel	SCD	8c2c3c5c-ddef-4a4d-8bc3-5a98c577e74c	13
750088	Gel-Kam 0.004 MG/MG Oral Gel	SY	8c2c3c5c-ddef-4a4d-8bc3-5a98c577e74c	13
750088	Gel-Kam 0.4 % Oral Gel	SY	8c2c3c5c-ddef-4a4d-8bc3-5a98c577e74c	13
237847	stannous fluoride 0.4 % (fluoride ion 0.16 % ) Oral Gel	SY	8c2c3c5c-ddef-4a4d-8bc3-5a98c577e74c	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0126-0192-93	00126019293	1 TUBE in 1 CARTON (0126-0192-93) / 122 g in 1 TUBE	1 tube	1990-01-01	0000-00-00	No	No	Current