orajel cold sore touch free - single dose

Generic: benzalkonium chloride, benzocaine

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

Drug Facts

Product Profile

Brand Name orajel cold sore touch free - single dose
Generic Name benzalkonium chloride, benzocaine
Labeler church & dwight co., inc.
Dosage Form LIQUID
Routes
TOPICAL
Active Ingredients

benzalkonium chloride 1.3 mg/mL, benzocaine 50 mg/mL

Manufacturer
Church & Dwight Co., Inc.

Identifiers & Regulatory

Product NDC 10237-798
Product ID 10237-798_45b02503-8f3a-8874-e063-6294a90a2d64
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2021-09-01

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 10237798
Hyphenated Format 10237-798

Supplemental Identifiers

RxCUI
2572114
UPC
0310310998943
UNII
F5UM2KM3W7 U3RSY48JW5
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 cold sore touch free - single dose (source: ndc)
Generic Name benzalkonium chloride, benzocaine (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1.3 mg/mL
  • 50 mg/mL
source: ndc
Packaging
  • 6 VIAL, SINGLE-DOSE in 1 PACKAGE (10237-798-35) / 3.5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

10237-798-35 6 VIAL, SINGLE-DOSE in 1 PACKAGE (10237-798-35) / 3.5 mL in 1 VIAL, SINGLE-DOSE

Ingredients (2)

benzalkonium chloride (1.3 mg/mL) benzocaine (50 mg/mL)

Linked Drug Pages (1)

Orajel Cold Sore Touch Free - Single Dose ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "45b02503-8f3a-8874-e063-6294a90a2d64", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728"], "upc": ["0310310998943"], "unii": ["F5UM2KM3W7", "U3RSY48JW5"], "rxcui": ["2572114"], "spl_set_id": ["ce40829e-941f-2548-e053-2995a90a1e0e"], "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": "6 VIAL, SINGLE-DOSE in 1 PACKAGE (10237-798-35)  / 3.5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "10237-798-35", "marketing_start_date": "20210901"}], "brand_name": "Orajel Cold Sore Touch Free - Single Dose", "product_id": "10237-798_45b02503-8f3a-8874-e063-6294a90a2d64", "dosage_form": "LIQUID", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Increased Histamine Release [PE]", "Standardized Chemical Allergen [EPC]"], "product_ndc": "10237-798", "generic_name": "Benzalkonium Chloride, Benzocaine", "labeler_name": "Church & Dwight Co., Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Orajel Cold Sore Touch Free - Single Dose", "active_ingredients": [{"name": "BENZALKONIUM CHLORIDE", "strength": "1.3 mg/mL"}, {"name": "BENZOCAINE", "strength": "50 mg/mL"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20210901", "listing_expiration_date": "20261231"}