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 |
|---|---|
| STANNOUS FLUORIDE | 1 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3FTR44B32Q | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8c2c3c5c-ddef-4a4d-8bc3-5a98c577e74c | Available on FDA.report |
DailyMed Package Descriptions#
| 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 | 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 | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| 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 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Crest Clean Breath Peppermint | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | 4f1ef07b-ee68-e6ae-e063-6394a90af5e5 | 2026-04-10 | Warnings | M021 |
| Crest Clean Breath Spearmint | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | 4f20343e-6c03-48e8-e063-6294a90a8cdf | 2026-04-10 | Warnings | M021 |
| Crest Clean Breath Smooth Mint | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | 4f2042b4-8eae-5c2c-e063-6394a90a640c | 2026-04-10 | Warnings | M021 |
| Crest 3D White Advanced Arctic Fresh with Stain-Blasting Foam | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 4ef4146d-6281-fe66-e063-6394a90a32c3 | 2026-04-09 | Warnings | M021 |
| Crest 3D White Advanced Glamorous White with Stain-Blasting Foam | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 4ef5261e-9d2f-ae05-e063-6294a90a489a | 2026-04-09 | Warnings | M021 |
| Crest 3D White Advanced Luminous Mint Daily Whitening Upkeep | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 4f0876d9-41c9-d891-e063-6394a90a1cbd | 2026-04-09 | Warnings | M021 |
| Crest 3D White Advanced Charcoal with Stain-Blasting Foam | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 4ef57a05-b9f5-42f7-e063-6294a90a5d89 | 2026-04-09 | Warnings | M021 |
| Crest 3D White Advanced Radiant Mint with Stain Blasting Foam | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 4ee26a82-16fd-f0fb-e063-6394a90a91d1 | 2026-04-09 | Warnings | M021 |
| Crest 3D White Whitening Therapy Deep Clean Charcoal | SODIUM FLUORIDE | Procter & Gamble Manfuacturing Company | 812c1519-1a4b-2495-e053-2a91aa0a914a | 2026-04-09 | Warnings | M021 |
| Crest 3D White Advanced Deep Clean with Stain-Blasting Foam | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 4ef4e7c2-1f58-59fc-e063-6294a90ad43b | 2026-04-08 | Warnings | M021 |
| Anticavity mouth rinse Low-foaming Spearmint | 779 US VARIANT ANTICAVITY MOUTH RINSE LOW-FOAMING SPEARMINT | Dyson Technology Limited | 4ef669b9-defe-8965-e063-6394a90ab335 | 2026-04-08 | Warnings | M021 |
| Crest 3D White Advanced Radiant Mint | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | f5c89efc-5fa0-2a05-e053-2a95a90a7b9c | 2026-04-07 | Warnings | M021 |
| Crest 3D White Advanced Charcoal | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | f4eb8111-53da-17ae-e053-2a95a90a1127 | 2026-04-07 | Warnings | M021 |
| Anticavity | SODIUM FLUORIDE | ADUSA Distribution, LLC | 35385ada-bd8d-4d38-9587-0256885f749f | 2026-04-07 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | ADUSA Distribution, LLC | cf0c8b48-0d1c-406a-a67d-7d16187d38d8 | 2026-04-07 | Warnings, Adverse reactions | M021 |
| Crest 3D White Arctic Fresh | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | fa08a877-b9e5-4eba-b832-3a28f4f3f83c | 2026-04-07 | Warnings | M021 |
| Anticavity Fluoride | SODIUM FLUORIDE | Family Dollar (FAMILY WELLNESS) | 63c4c0e9-84b1-4076-bdf4-7e9543b2cf46 | 2026-04-01 | Warnings | M021 |
| CloSYS Silver Sensitive Mouth Rinse Fluoride Rinse | SODIUM FLUORIDE | Rowpar Pharmaceuticals, Inc. | 98a8cee8-9f3c-4a4a-89f8-72e1f1b06796 | 2026-04-01 | Warnings | M021 |
| CloSYS | SODIUM FLUORIDE | Rowpar Pharmaceuticals, Inc. | 5f87abb7-0e9d-6369-e053-2a91aa0a2411 | 2026-03-31 | Warnings | M021 |
| Crest Clean Breath Spearmint | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | 4e544d09-0cf3-f0c7-e063-6394a90a2369 | 2026-03-31 | Warnings | M021 |
DailyMed RxNorm Mappings#
| 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 | 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 |