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 6 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Freshen Up chai latte mint	SODIUM FLUORIDE	MKJ BRANDS LLC	52e364f9-113a-df4e-e063-6294a90a263b	2026-07-14	Warnings	Exact identifier application number: M021
Freshen Up Holiday mint	SODIUM FLUORIDE	MKJ BRANDS LLC	5257c409-d379-8c48-e063-6294a90acda9	2026-07-14	Warnings	Exact identifier application number: M021
Freshen-up Matcha Mint	SODIUM FLUORIDE	MKJ BRANDS LLC	52bbc6d9-17ab-851a-e063-6394a90ab4bf	2026-07-14	Warnings	Exact identifier application number: M021
Freshen Up pepper mint	SODIUM FLUORIDE	MKJ BRANDS LLC	5259bc45-85da-b17b-e063-6294a90a7919	2026-07-14	Warnings	Exact identifier application number: M021
Colgate Optic White Advanced Icy Fresh	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	f95496e3-11ec-4cd6-b3ee-cf6c657b790b	2026-07-13	Warnings	Exact identifier application number: M021
COLGATE MAX FRESH COCONUT PINEAPPLE	SODIUM FLUORIDE	Colgate-Palmolive Company	7f240d1d-ea3d-42b1-a4b0-106c58707452	2026-07-08	Warnings	Exact identifier application number: M021
Crest 3D White Deep Stain Remover Ultra White	SODIUM MONOFLUOROPHOSPHATE	The Procter & Gamble Manufacturing Company	2f24a9eb-7a89-30e1-e063-6394a90a032b	2026-07-08		Exact identifier application number: M021
Dr. Noah Kids Tooth	SODIUM MONOFLUOROPHOSPHATE	Project Noah Inc.	562311aa-9ac5-00c2-e063-6394a90a67a7	2026-07-08	Warnings	Exact identifier application number: M021
COLGATE BAKING SODA AND PEROXIDE WHITENING OXYGEN BUBBLES FROSTY MINT	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	263fef13-347b-489b-987d-933a63dbc900	2026-07-08	Warnings	Exact identifier application number: M021
Colgate Triple Action	SODIUM FLUORIDE	Colgate-Palmolive Company	3082e9ba-66d9-4fc7-bbe6-b41b60939bd2	2026-07-08	Warnings	Exact identifier application number: M021
Colgate Junior Kids Batman Mild Bubble Fruit Fluoride	SODIUM FLUORIDE	Colgate-Palmolive Company	f464cecb-e876-4057-ab5c-94de747434db	2026-07-08	Warnings	Exact identifier application number: M021
Crest Premium Plus Scope Active Foam plus Whitening Minty Fresh	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	560815d6-018a-0c24-e063-6394a90a1071	2026-07-07	Warnings	Exact identifier application number: M021
Crest Plus Scope plus Whitening with Mouthwash	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	54ecfbed-ba99-11eb-e063-6294a90ae64d	2026-07-07	Warnings	Exact identifier application number: M021
Crest Plus Scope plus Whitening Minty Fresh with Mouthwash striped	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	56091601-74dd-0a3b-e063-6394a90af476	2026-07-07	Warnings	Exact identifier application number: M021
Crest Plus Scope plus Whitening Outlast Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	55054217-f21b-1c41-e063-6394a90ae40b	2026-07-07	Warnings	Exact identifier application number: M021
Hello Dragon Dazzle Dragon Dazzle Fluoride	SODIUM FLUORIDE	Colgate-Palmolive Company	eaca1ad1-9e31-b904-4148-247ad2460661	2026-07-07	Warnings	Exact identifier application number: M021
Colgate Cavity Protection	SODIUM FLUORIDE	Colgate-Palmolive Company	cdd2ad04-8c65-40f2-b323-5ce11af52e4f	2026-07-06	Warnings	Exact identifier application number: M021
AIM Cavity Protection with Whitening	SODIUM FLUORIDE	Church & Dwight Co., Inc.	a8c742e1-ee61-4593-b8f5-b9e586d39dfc	2026-07-01	Warnings	Exact identifier application number: M021
TOMS OF MAINE ANTICAVITY FRESHMINT	SODIUM FLUORIDE	Tom's of Maine	6f825520-0f8a-4b4c-bbb6-987f64ab8769	2026-07-01	Warnings	Exact identifier application number: M021
Colgate Deep Clean Fluoride	SODIUM FLUORIDE	Colgate-Palmolive Company	47e8e943-f4d5-40bc-8f79-ec9ea06125de	2026-07-01	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