orajel cold sore moisturelock

Generic: 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 moisturelock
Generic Name benzocaine
Labeler church & dwight co., inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

allantoin 5 mg/g, benzocaine 200 mg/g, camphor (natural) 30 mg/g, dimethicone 20 mg/g, menthol 10 mg/g, petrolatum 640 mg/g

Manufacturer
Church & Dwight Co., Inc.

Identifiers & Regulatory

Product NDC 10237-761
Product ID 10237-761_27d37e6f-4fd8-ce0e-e063-6394a90ad259
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2026-12-31
Marketing Start 2016-07-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 10237761
Hyphenated Format 10237-761

Supplemental Identifiers

RxCUI
2257305
UPC
0310310998820
UNII
344S277G0Z U3RSY48JW5 N20HL7Q941 92RU3N3Y1O L7T10EIP3A 4T6H12BN9U
NUI
N0000185508 N0000175629 N0000184306 M0000728 N0000010282

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 moisturelock (source: ndc)
Generic Name benzocaine (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/g
  • 200 mg/g
  • 30 mg/g
  • 20 mg/g
  • 10 mg/g
  • 640 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (10237-761-01) / 3 g in 1 TUBE
source: ndc

Packages (1)

10237-761-01 1 TUBE in 1 CARTON (10237-761-01) / 3 g in 1 TUBE

Ingredients (6)

allantoin (5 mg/g) benzocaine (200 mg/g) camphor (natural) (30 mg/g) dimethicone (20 mg/g) menthol (10 mg/g) petrolatum (640 mg/g)

Linked Drug Pages (1)

Orajel Cold Sore Moisturelock ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "27d37e6f-4fd8-ce0e-e063-6394a90ad259", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728", "N0000010282"], "upc": ["0310310998820"], "unii": ["344S277G0Z", "U3RSY48JW5", "N20HL7Q941", "92RU3N3Y1O", "L7T10EIP3A", "4T6H12BN9U"], "rxcui": ["2257305"], "spl_set_id": ["3761c7b3-053b-0f50-e054-00144ff88e88"], "pharm_class_cs": ["Allergens [CS]"], "pharm_class_pe": ["Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]", "Skin Barrier Activity [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 (10237-761-01)  / 3 g in 1 TUBE", "package_ndc": "10237-761-01", "marketing_start_date": "20160701"}], "brand_name": "Orajel Cold Sore Moisturelock", "product_id": "10237-761_27d37e6f-4fd8-ce0e-e063-6394a90ad259", "dosage_form": "CREAM", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Increased Histamine Release [PE]", "Skin Barrier Activity [PE]", "Standardized Chemical Allergen [EPC]"], "product_ndc": "10237-761", "generic_name": "Benzocaine", "labeler_name": "Church & Dwight Co., Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Orajel Cold Sore Moisturelock", "active_ingredients": [{"name": "ALLANTOIN", "strength": "5 mg/g"}, {"name": "BENZOCAINE", "strength": "200 mg/g"}, {"name": "CAMPHOR (NATURAL)", "strength": "30 mg/g"}, {"name": "DIMETHICONE", "strength": "20 mg/g"}, {"name": "MENTHOL", "strength": "10 mg/g"}, {"name": "PETROLATUM", "strength": "640 mg/g"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20160701", "listing_expiration_date": "20261231"}