gel 1100 mint

Generic: sodium fluoride

Labeler: dental alliance holdings llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name gel 1100 mint
Generic Name sodium fluoride
Labeler dental alliance holdings llc
Dosage Form GEL, DENTIFRICE
Routes
DENTAL
Active Ingredients

sodium fluoride 1100 ug/g

Manufacturer
Dental Alliance Holdings LLC

Identifiers & Regulatory

Product NDC 61578-213
Product ID 61578-213_8c79367f-d60d-484b-8e32-87de7cf75358
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M021
Listing Expiration 2026-12-31
Marketing Start 2022-05-10

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61578213
Hyphenated Format 61578-213

Supplemental Identifiers

RxCUI
416783
UPC
0856596006007 0856596006021 0856596006014
UNII
8ZYQ1474W7

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name gel 1100 mint (source: ndc)
Generic Name sodium fluoride (source: ndc)
Application Number M021 (source: ndc)
Routes
DENTAL
source: ndc

Resolved Composition

Strengths
  • 1100 ug/g
source: ndc
Packaging
  • 68 g in 1 TUBE, WITH APPLICATOR (61578-213-01)
  • 24.1 g in 1 TUBE, WITH APPLICATOR (61578-213-02)
source: ndc

Packages (2)

61578-213-01 68 g in 1 TUBE, WITH APPLICATOR (61578-213-01) 61578-213-02 24.1 g in 1 TUBE, WITH APPLICATOR (61578-213-02)

Ingredients (1)

sodium fluoride (1100 ug/g)

Linked Drug Pages (1)

Gel 1100 Mint, Gel 1100 Citrus, Gel 1100 Grape ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["DENTAL"], "spl_id": "8c79367f-d60d-484b-8e32-87de7cf75358", "openfda": {"upc": ["0856596006007", "0856596006021", "0856596006014"], "unii": ["8ZYQ1474W7"], "rxcui": ["416783"], "spl_set_id": ["f125fb04-5045-5367-e053-2a95a90aa73b"], "manufacturer_name": ["Dental Alliance Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "68 g in 1 TUBE, WITH APPLICATOR (61578-213-01)", "package_ndc": "61578-213-01", "marketing_start_date": "20220510"}, {"sample": true, "description": "24.1 g in 1 TUBE, WITH APPLICATOR (61578-213-02)", "package_ndc": "61578-213-02", "marketing_start_date": "20251101"}], "brand_name": "Gel 1100 Mint", "product_id": "61578-213_8c79367f-d60d-484b-8e32-87de7cf75358", "dosage_form": "GEL, DENTIFRICE", "product_ndc": "61578-213", "generic_name": "sodium fluoride", "labeler_name": "Dental Alliance Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Gel 1100", "brand_name_suffix": "Mint", "active_ingredients": [{"name": "SODIUM FLUORIDE", "strength": "1100 ug/g"}], "application_number": "M021", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20220510", "listing_expiration_date": "20261231"}