Gel-Kam Fruit and Berry

Product NDC: 0126-0165
11-digit product format: 001260165
Labeler code: 0126
Product ID: 0126-0165_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 Fruit and Berry
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
0126-0165-93	Gel-Kam Fruit and Berry	122 g in 1 TUBE	GEL, DENTIFRICE	122		13
0126-0165-93	Gel-Kam Fruit and Berry	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
0126-0165-93	GM - Gram	0126-0165	e4d91c1c-ce35-4abb-b0c2-8f5631a05262	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
0126-0165	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 8 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Crest Plus Scope plus Whitening Minty Fresh with Mouthwash	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	54ed8e02-3c2f-750c-e063-6394a90a4d33	2026-06-23	Warnings	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	H E B	c68b0644-685d-4c62-bf5d-3a5bbea3b052	2026-06-22	Warnings, Adverse reactions	Exact identifier application number: M021
Tom Whole Care Peppermint fights cavities whitening fresh breath helps fight tartar	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	fdbadaae-eab7-4d9a-acf7-815ca93f877c	2026-06-16	Warnings	Exact identifier application number: M021
Natural Fluoride Fresh Mint cavity protection whitening fresh breath	SODIUM FLUORIDE	Tom's of Maine, Inc.	fce5e8b5-34f8-4a45-a662-82c903419809	2026-06-16	Warnings	Exact identifier application number: M021
Toms Whole Care Spearmint fights cavities whitening fresh breath helps fight tartar	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	ebb62015-0027-459a-a9cf-56b640f9f456	2026-06-16	Warnings	Exact identifier application number: M021
Toms Wicked Fresh Spearmint Ice fresh breath / cavity protection	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	b9962eac-186e-4da2-929d-393f18ed0234	2026-06-16	Warnings	Exact identifier application number: M021
Toms Wicked Fresh Cool Peppermint fresh breath / cavity protection	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	1c029b10-29b0-4131-9134-cebfca4328a3	2026-06-16	Warnings	Exact identifier application number: M021
Toms Whole Care Cinnamon Clove FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	3e7ab39a-989c-4924-af3e-689404912bee	2026-06-16	Warnings	Exact identifier application number: M021
Crest Plus Cinnamon plus Whitening	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	53fb780d-3e8b-6747-e063-6294a90a8211	2026-06-11	Warnings	Exact identifier application number: M021
Colgate Total SF Whitening	STANNOUS FLUORIDE	COLGATE PALMOLIVE COMPANY	7f6b6aa8-50da-151b-c448-9e427d37398f	2026-06-11	Warnings	Exact identifier application number: M021
Colgate MaxClean with Whitening Smartfoam	SODIUM FLUORIDE	Colgate-Palmolive Company	c712ae6b-eff3-4c54-b1fc-37304758d059	2026-06-11	Warnings	Exact identifier application number: M021
Colgate Total Sensitivity Mineral Shield	STANNOUS FLUORIDE	Colgate-Palmolive Company	f065318c-1e2a-c04d-f254-f8127b05a88f	2026-06-10	Warnings	Exact identifier application number: M021
Toms Whole Care Mouthwash Fresh Mint	SODIUM FLUORIDE	Tom's of Maine, Inc.	6875f5c1-853c-43da-8226-c09a5518f9bb	2026-06-10	Warnings	Exact identifier application number: M021
Colgate Total SF Fresh Mint Stripe	STANNOUS FLUORIDE	COLGATE PALMOLIVE COMPANY	657020c7-e85c-4c61-9f62-b50351e4b4e5	2026-06-10	Warnings	Exact identifier application number: M021
Optimax Anticavity Fluoride Bubblegum	SODIUM MONOFLUOROPHOSPHATE	White Glo USA Inc	1adc752b-2ba8-4d8f-b4f1-5741f864255b	2026-06-09	Warnings	Exact identifier application number: M021
Kids Crest Cavity Protection Sparkle Fun	SODIUM FLUORIDE	Procter & Gamble Manufactura, S. de R.L. de C.V.	df182c22-bbf1-448d-81e8-35cb431d2afc	2026-06-08	Warnings	Exact identifier application number: M021
PEROXICARE	SODIUM FLUORIDE	Church & Dwight Co., Inc.	55262538-15ce-455c-93b1-bb02b5f81d6b	2026-06-07	Warnings	Exact identifier application number: M021
Optimax Anticavity Fluoride Raspberry	SODIUM MONOFLUOROPHOSPHATE	White Glo USA Inc	57e1d1cb-da58-4cd2-b960-4056e0b0d214	2026-06-05	Warnings	Exact identifier application number: M021
3ECARE Dual FormulaWhiteningToothpaste	SODIUM FLUORIDE	Hangzhou Namei Zhikang Technology Co., Ltd.	533fb7dd-7f84-59c5-e063-6394a90accad	2026-06-02	Warnings	Exact identifier application number: M021
3ECARE Dual FormulaToothpastefor sensitiveteeth	POTASSIUM NITRATE SODIUM MONOFLUOROPHOSPHATE	Hangzhou Namei Zhikang Technology Co., Ltd.	533fc83e-a8cf-15c1-e063-6294a90a7b74	2026-06-02	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
0126-0165-93	00126016593	1 TUBE in 1 CARTON (0126-0165-93) / 122 g in 1 TUBE	1 tube	1990-01-01	0000-00-00	No	No	Current