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 16 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Toms of Maine Whiten Plus Deep Clean Peppermint	SODIUM FLUORIDE	Tom's of Maine	4c535776-3f80-4eeb-bb63-2d734c3c3a6b	2026-02-18	Warnings	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	United Natural Foods, Inc. dba UNFI	dd6bf8df-1e28-4f61-b876-b9f1f8d5993a	2026-02-17	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	United Natural Foods, Inc. dba UNFI	8283cea0-7b62-4796-8763-6654039664cd	2026-02-17	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	United Natural Foods, Inc. dba UNFI	9d055fed-26d8-4827-a4cc-8c314514a6c3	2026-02-17	Warnings	Exact identifier application number: M021
Brush Buddies Crayola Color Changing ANTICAVITY FLUORIDE WATERMELON FLAVOR	SODIUM FLUORIDE	Ashtel Studios, Inc.	28d1b8c3-930f-4ac9-aa5a-b72b832bb77e	2026-02-17	Warnings	Exact identifier application number: M021
Anticavity Rinse	SODIUM FLUORIDE	Valu Merchandisers Company	088b95e6-30fd-4263-9fdc-57cd63385b71	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	Valu Merchandisers Company	e31c1609-a1c3-4ed5-adfd-3cfa63205ec3	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	United Natural Foods, Inc. dba UNFI	3602c528-5f53-4d41-bf67-163149f52b35	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	United Natural Foods, Inc. dba UNFI	e696038c-182e-4325-9b90-87fe498d9f67	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	Topco Associates LLC	3b04142a-4a65-45ba-a5a2-e62b0c47ec55	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M021
Mouth Rinse	SODIUM FLUORIDE	Topco Associates LLC	c640adc0-e178-4b6a-af44-07d2f7da81d3	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	Topco Associates LLC	f760f8f8-0c74-4a6e-b5c9-cc82b8758a45	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M021
Alcohol-Free Anticavity	SODIUM FLUORIDE	Topco Associates LLC	ade7dcb2-b4e2-4cef-b9a7-469867ead68a	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M021
Oral Antivavity	SODIUM FLUORIDE	Topco Associates LLC	84b30711-a7e5-4189-895a-a7989f05591c	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity fluoride rinse	SODIUM FLUORIDE	Topco Associates LLC	c3f2e952-a8d5-4e9d-a5c6-09e4f2544179	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Topco Associates LLC	a9b8b2fe-0a60-4f65-b6f6-aae8509c919f	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M021
Salivea	FLUORIDE TOOTHPASTE	Laclede, Inc.	4abb0f80-d87d-730f-e063-6294a90a15f7	2026-02-13	Warnings	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Your Military Exchanges	581d5cdb-018a-42ad-899d-5331f0063376	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: M021
Alcohol-Free Anticavity	SODIUM FLUORIDE	Your Military Exchanges	965911c3-7aa8-4830-8269-6aa5d526ee73	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: M021
Mouth Rinse	SODIUM FLUORIDE	Walgreen Co.	eae87899-3eba-4d50-bc31-9eaf54ff9e00	2026-02-12	Warnings, Adverse reactions	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