orajel 2x medicated gel

Generic: oral pain reliever

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

Drug Facts

Product Profile

Brand Name orajel 2x medicated gel
Generic Name oral pain reliever
Labeler church & dwight co., inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

benzocaine 200 mg/g, menthol 2.6 mg/g

Manufacturer
Church & Dwight Co., Inc.

Identifiers & Regulatory

Product NDC 10237-782
Product ID 10237-782_262be295-4eb0-3136-e063-6294a90a7dcc
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Listing Expiration 2026-12-31
Marketing Start 2022-05-23

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 10237782
Hyphenated Format 10237-782

Supplemental Identifiers

RxCUI
2117337
UPC
0310310430283
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 2x medicated gel (source: ndc)
Generic Name oral pain reliever (source: ndc)
Application Number M022 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/g
  • 2.6 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (10237-782-25) / 7 g in 1 TUBE
source: ndc

Packages (1)

10237-782-25 1 TUBE in 1 CARTON (10237-782-25) / 7 g in 1 TUBE

Ingredients (2)

benzocaine (200 mg/g) menthol (2.6 mg/g)

Linked Drug Pages (1)

Orajel 2X Medicated Gel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "262be295-4eb0-3136-e063-6294a90a7dcc", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728"], "upc": ["0310310430283"], "unii": ["U3RSY48JW5", "L7T10EIP3A"], "rxcui": ["2117337"], "spl_set_id": ["262be295-4eaf-3136-e063-6294a90a7dcc"], "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 TUBE in 1 CARTON (10237-782-25)  / 7 g in 1 TUBE", "package_ndc": "10237-782-25", "marketing_start_date": "20220523"}], "brand_name": "Orajel 2X Medicated Gel", "product_id": "10237-782_262be295-4eb0-3136-e063-6294a90a7dcc", "dosage_form": "GEL", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Increased Histamine Release [PE]", "Standardized Chemical Allergen [EPC]"], "product_ndc": "10237-782", "generic_name": "Oral Pain Reliever", "labeler_name": "Church & Dwight Co., Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Orajel 2X Medicated Gel", "active_ingredients": [{"name": "BENZOCAINE", "strength": "200 mg/g"}, {"name": "MENTHOL", "strength": "2.6 mg/g"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20220523", "listing_expiration_date": "20261231"}