orajel sensitivity relief

Generic: sodium fluoride and potassium nitrate

Labeler: church & dwight co., inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name orajel sensitivity relief
Generic Name sodium fluoride and potassium nitrate
Labeler church & dwight co., inc.
Dosage Form PASTE, DENTIFRICE
Routes
ORAL
Active Ingredients

potassium nitrate 5 g/100g, sodium fluoride .243 g/100g

Manufacturer
Church & Dwight Co., Inc.

Identifiers & Regulatory

Product NDC 10237-678
Product ID 10237-678_88d71cb7-8abf-407d-a74c-f5537497759a
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M021
Listing Expiration 2026-12-31
Marketing Start 2024-01-31

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 10237678
Hyphenated Format 10237-678

Supplemental Identifiers

UNII
RU45X2JN0Z 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 orajel sensitivity relief (source: ndc)
Generic Name sodium fluoride and potassium nitrate (source: ndc)
Application Number M021 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 g/100g
  • .243 g/100g
source: ndc
Packaging
  • 2 TUBE in 1 CARTON (10237-678-12) / 170 g in 1 TUBE
  • 121.9 g in 1 TUBE (10237-678-43)
source: ndc

Packages (2)

Ingredients (2)

potassium nitrate (5 g/100g) sodium fluoride (.243 g/100g)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "88d71cb7-8abf-407d-a74c-f5537497759a", "openfda": {"unii": ["RU45X2JN0Z", "8ZYQ1474W7"], "spl_set_id": ["7b9d9e7d-3844-4d18-ab03-bd0e9dcfccdb"], "manufacturer_name": ["Church & Dwight Co., Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TUBE in 1 CARTON (10237-678-12)  / 170 g in 1 TUBE", "package_ndc": "10237-678-12", "marketing_start_date": "20240601"}, {"sample": false, "description": "121.9 g in 1 TUBE (10237-678-43)", "package_ndc": "10237-678-43", "marketing_start_date": "20240131"}], "brand_name": "Orajel Sensitivity Relief", "product_id": "10237-678_88d71cb7-8abf-407d-a74c-f5537497759a", "dosage_form": "PASTE, DENTIFRICE", "product_ndc": "10237-678", "generic_name": "Sodium Fluoride and Potassium Nitrate", "labeler_name": "Church & Dwight Co., Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Orajel Sensitivity Relief", "active_ingredients": [{"name": "POTASSIUM NITRATE", "strength": "5 g/100g"}, {"name": "SODIUM FLUORIDE", "strength": ".243 g/100g"}], "application_number": "M021", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240131", "listing_expiration_date": "20261231"}