orajel for cold sores double medicated, cream

Generic: benzocaine and white petrolatum

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

Drug Facts

Product Profile

Brand Name orajel for cold sores double medicated, cream
Generic Name benzocaine and white petrolatum
Labeler church & dwight co., inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

benzocaine 200 mg/g, petrolatum 736.4 mg/g

Manufacturer
Church & Dwight Co., Inc.

Identifiers & Regulatory

Product NDC 10237-797
Product ID 10237-797_45382973-75d6-bf98-e063-6294a90a50fc
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2021-01-18

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 10237797
Hyphenated Format 10237-797

Supplemental Identifiers

UNII
U3RSY48JW5 4T6H12BN9U
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 for cold sores double medicated, cream (source: ndc)
Generic Name benzocaine and white petrolatum (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/g
  • 736.4 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (10237-797-12) / 3.5 g in 1 TUBE
source: ndc

Packages (1)

10237-797-12 1 TUBE in 1 CARTON (10237-797-12) / 3.5 g in 1 TUBE

Ingredients (2)

benzocaine (200 mg/g) petrolatum (736.4 mg/g)

Linked Drug Pages (1)

Orajel for Cold Sores Double Medicated, Cream ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "45382973-75d6-bf98-e063-6294a90a50fc", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728"], "unii": ["U3RSY48JW5", "4T6H12BN9U"], "spl_set_id": ["b8699a40-8464-ca02-e053-2995a90a4260"], "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 (10237-797-12)  / 3.5 g in 1 TUBE", "package_ndc": "10237-797-12", "marketing_start_date": "20210118"}], "brand_name": "Orajel for Cold Sores Double Medicated, Cream", "product_id": "10237-797_45382973-75d6-bf98-e063-6294a90a50fc", "dosage_form": "CREAM", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Increased Histamine Release [PE]", "Standardized Chemical Allergen [EPC]"], "product_ndc": "10237-797", "generic_name": "Benzocaine and White Petrolatum", "labeler_name": "Church & Dwight Co., Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Orajel for Cold Sores Double Medicated, Cream", "active_ingredients": [{"name": "BENZOCAINE", "strength": "200 mg/g"}, {"name": "PETROLATUM", "strength": "736.4 mg/g"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20210118", "listing_expiration_date": "20261231"}