Gel-kam Fruit And Berry Gel, Dentifrice
NDC Package 0126-0165-93
Package Information
Gel-kam Fruit And Berry (stannous fluoride) gel is adults and children 12 years of age or older: use after regular brushing and flossingshake excess water from your toothbrush and cover bristles with gelbrush thoroughlykeep on your teeth for one minute and then spit outdo not swallowdo not rinse, eat or drink for 30 minutesuse once a day for cavity protectionuse twice a day (morning and evening) for sensitivity relief or as recommended by a dentist or physicianmake sure all sensitive areas are covered by using a toothbrush or a cotton swabsupervise children until capable of using without supervisionchildren under 12 years of age: consult a dentist or physician. This formulation utilizes a gel, dentifrice delivery system. Marketed by Colgate Oral Pharmaceuticals, Inc., this product is identified by NDC 0126-0165 and is authorized under FDA application M021.
Identification & Billing
- RxCUI: 237847 - stannous fluoride 0.4 % Oral Gel
- RxCUI: 237847 - stannous fluoride 0.004 MG/MG Oral Gel
- RxCUI: 237847 - stannous fluoride 0.4 % (fluoride ion 0.16 % ) Oral Gel
- RxCUI: 750088 - Gel-Kam 0.4 % Oral Gel
- RxCUI: 750088 - stannous fluoride 0.004 MG/MG Oral Gel [Gel-Kam]
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 0126 - Colgate Oral Pharmaceuticals, Inc.
- 0126-0165 - Gel-kam Fruit And Berry
- 0126-0165-93 - 1 TUBE in 1 CARTON / 122 g in 1 TUBE
- 0126-0165 - Gel-kam Fruit And Berry
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 0126-0165-93 identifies a specific commercial package of 1 tube in 1 carton / 122 g in 1 tube of Gel-kam Fruit And Berry, a human over the counter drug labeled by Colgate Oral Pharmaceuticals, Inc.. This product is billed per "GM" gram and contains an estimated amount of 122 billable units per package. This gel, dentifrice is formulated for dental use and contains stannous fluoride as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Colgate Oral Pharmaceuticals, Inc. on January 01, 1990. The current certification is valid through December 31, 2026.
How is this Colgate Oral Pharmaceuticals, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 00126016593. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 122 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.
