omni

Generic: stannous fluoride

Labeler: solventum us llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name omni
Generic Name stannous fluoride
Labeler solventum us llc
Dosage Form GEL
Routes
ORAL
Active Ingredients

stannous fluoride .969 mg/g

Manufacturer
Solventum US LLC

Identifiers & Regulatory

Product NDC 48878-4061
Product ID 48878-4061_5f88065a-e74d-4285-93d2-b208bf197523
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M021
Listing Expiration 2026-12-31
Marketing Start 1998-02-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 488784061
Hyphenated Format 48878-4061

Supplemental Identifiers

UNII
3FTR44B32Q

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 omni (source: ndc)
Generic Name stannous fluoride (source: ndc)
Application Number M021 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .969 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 BOX (48878-4061-3) / 121.9 g in 1 TUBE
source: ndc

Packages (1)

48878-4061-3 1 TUBE in 1 BOX (48878-4061-3) / 121.9 g in 1 TUBE

Ingredients (1)

stannous fluoride (.969 mg/g)

Linked Drug Pages (1)

OMNI ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5f88065a-e74d-4285-93d2-b208bf197523", "openfda": {"unii": ["3FTR44B32Q"], "spl_set_id": ["0c2a81b1-65b5-432b-8e66-30432a245aba"], "manufacturer_name": ["Solventum US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 BOX (48878-4061-3)  / 121.9 g in 1 TUBE", "package_ndc": "48878-4061-3", "marketing_start_date": "19980201"}], "brand_name": "OMNI", "product_id": "48878-4061_5f88065a-e74d-4285-93d2-b208bf197523", "dosage_form": "GEL", "product_ndc": "48878-4061", "generic_name": "Stannous Fluoride", "labeler_name": "Solventum US LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "OMNI", "active_ingredients": [{"name": "STANNOUS FLUORIDE", "strength": ".969 mg/g"}], "application_number": "M021", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "19980201", "listing_expiration_date": "20261231"}