orajel medicated for toothache and gum, liquid

Generic: benzocaine and menthol

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

Drug Facts

Product Profile

Brand Name orajel medicated for toothache and gum, liquid
Generic Name benzocaine and menthol
Labeler church & dwight co., inc.
Dosage Form LIQUID
Routes
TOPICAL
Active Ingredients

benzocaine 200 mg/mL, menthol, unspecified form 1 mg/mL

Manufacturer
Church & Dwight Co., Inc.

Identifiers & Regulatory

Product NDC 10237-796
Product ID 10237-796_45a8ca6b-0e37-9397-e063-6394a90a5bde
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Listing Expiration 2026-12-31
Marketing Start 2020-08-07

Pharmacologic Class

Established (EPC)
standardized chemical allergen [epc]
Chemical Structure
allergens [cs]
Physiologic Effect
increased histamine release [pe] cell-mediated immunity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 10237796
Hyphenated Format 10237-796

Supplemental Identifiers

RxCUI
2110600
UNII
U3RSY48JW5 L7T10EIP3A
NUI
N0000185508 N0000175629 N0000184306 M0000728

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 medicated for toothache and gum, liquid (source: ndc)
Generic Name benzocaine and menthol (source: ndc)
Application Number M022 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/mL
  • 1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, GLASS in 1 CARTON (10237-796-45) / 13.3 mL in 1 BOTTLE, GLASS
source: ndc

Packages (1)

10237-796-45 1 BOTTLE, GLASS in 1 CARTON (10237-796-45) / 13.3 mL in 1 BOTTLE, GLASS

Ingredients (2)

benzocaine (200 mg/mL) menthol, unspecified form (1 mg/mL)

Linked Drug Pages (1)

Orajel Medicated for Toothache and Gum, Liquid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "45a8ca6b-0e37-9397-e063-6394a90a5bde", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728"], "unii": ["U3RSY48JW5", "L7T10EIP3A"], "rxcui": ["2110600"], "spl_set_id": ["ac3d605d-241d-1a6f-e053-2a95a90ae391"], "pharm_class_cs": ["Allergens [CS]"], "pharm_class_pe": ["Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]"], "pharm_class_epc": ["Standardized Chemical Allergen [EPC]"], "manufacturer_name": ["Church & Dwight Co., Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, GLASS in 1 CARTON (10237-796-45)  / 13.3 mL in 1 BOTTLE, GLASS", "package_ndc": "10237-796-45", "marketing_start_date": "20200807"}], "brand_name": "Orajel Medicated for Toothache and Gum, Liquid", "product_id": "10237-796_45a8ca6b-0e37-9397-e063-6394a90a5bde", "dosage_form": "LIQUID", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Increased Histamine Release [PE]", "Standardized Chemical Allergen [EPC]"], "product_ndc": "10237-796", "generic_name": "Benzocaine and Menthol", "labeler_name": "Church & Dwight Co., Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Orajel Medicated for Toothache and Gum, Liquid", "active_ingredients": [{"name": "BENZOCAINE", "strength": "200 mg/mL"}, {"name": "MENTHOL, UNSPECIFIED FORM", "strength": "1 mg/mL"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20200807", "listing_expiration_date": "20261231"}