orajel 4x medicated for toothache and gum

Generic: benzalkonium chloride, benzocaine, menthol, zinc chloride

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

Drug Facts

Product Profile

Brand Name orajel 4x medicated for toothache and gum
Generic Name benzalkonium chloride, benzocaine, menthol, zinc chloride
Labeler church & dwight co., inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

benzalkonium chloride 1.3 mg/g, benzocaine 200 mg/g, menthol, unspecified form 5 mg/g, zinc chloride 1.5 mg/g

Manufacturer
Church & Dwight Co., Inc.

Identifiers & Regulatory

Product NDC 10237-787
Product ID 10237-787_45c2eac1-8aed-0f2f-e063-6294a90a0602
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Listing Expiration 2026-12-31
Marketing Start 2019-11-01

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 10237787
Hyphenated Format 10237-787

Supplemental Identifiers

RxCUI
2369638
UNII
F5UM2KM3W7 U3RSY48JW5 L7T10EIP3A 86Q357L16B
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 4x medicated for toothache and gum (source: ndc)
Generic Name benzalkonium chloride, benzocaine, menthol, zinc chloride (source: ndc)
Application Number M022 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1.3 mg/g
  • 200 mg/g
  • 5 mg/g
  • 1.5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (10237-787-25) / 7 g in 1 TUBE
source: ndc

Packages (1)

10237-787-25 1 TUBE in 1 CARTON (10237-787-25) / 7 g in 1 TUBE

Ingredients (4)

benzalkonium chloride (1.3 mg/g) benzocaine (200 mg/g) menthol, unspecified form (5 mg/g) zinc chloride (1.5 mg/g)

Linked Drug Pages (1)

Orajel 4X Medicated For Toothache and Gum ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "45c2eac1-8aed-0f2f-e063-6294a90a0602", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728"], "unii": ["F5UM2KM3W7", "U3RSY48JW5", "L7T10EIP3A", "86Q357L16B"], "rxcui": ["2369638"], "spl_set_id": ["999851ac-925c-7d1f-e053-2a95a90a240b"], "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 (10237-787-25)  / 7 g in 1 TUBE", "package_ndc": "10237-787-25", "marketing_start_date": "20191101"}], "brand_name": "Orajel 4X Medicated For Toothache and Gum", "product_id": "10237-787_45c2eac1-8aed-0f2f-e063-6294a90a0602", "dosage_form": "GEL", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]", "Increased Histamine Release [PE]", "Standardized Chemical Allergen [EPC]"], "product_ndc": "10237-787", "generic_name": "Benzalkonium chloride, Benzocaine, Menthol, Zinc chloride", "labeler_name": "Church & Dwight Co., Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Orajel 4X Medicated For Toothache and Gum", "active_ingredients": [{"name": "BENZALKONIUM CHLORIDE", "strength": "1.3 mg/g"}, {"name": "BENZOCAINE", "strength": "200 mg/g"}, {"name": "MENTHOL, UNSPECIFIED FORM", "strength": "5 mg/g"}, {"name": "ZINC CHLORIDE", "strength": "1.5 mg/g"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20191101", "listing_expiration_date": "20261231"}