benzocaine

Generic: topical anesthetic

Labeler: everpharm llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name benzocaine
Generic Name topical anesthetic
Labeler everpharm llc
Dosage Form SPRAY
Routes
DENTAL PERIODONTAL
Active Ingredients

benzocaine 200 mg/mL

Manufacturer
Everpharm LLC

Identifiers & Regulatory

Product NDC 84415-044
Product ID 84415-044_2bc582da-83f3-1644-e063-6294a90a8968
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Listing Expiration 2026-12-31
Marketing Start 2025-01-15

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 84415044
Hyphenated Format 84415-044

Supplemental Identifiers

RxCUI
360348
UPC
0384415044010
UNII
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 benzocaine (source: ndc)
Generic Name topical anesthetic (source: ndc)
Application Number M022 (source: ndc)
Routes
DENTAL PERIODONTAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/mL
source: ndc
Packaging
  • 25 POUCH in 1 PACKAGE (84415-044-01) / 1 APPLICATOR in 1 POUCH / .5 mL in 1 APPLICATOR
source: ndc

Packages (1)

84415-044-01 25 POUCH in 1 PACKAGE (84415-044-01) / 1 APPLICATOR in 1 POUCH / .5 mL in 1 APPLICATOR

Ingredients (1)

benzocaine (200 mg/mL)

Linked Drug Pages (1)

Benzocaine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["DENTAL", "PERIODONTAL"], "spl_id": "2bc582da-83f3-1644-e063-6294a90a8968", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728"], "upc": ["0384415044010"], "unii": ["U3RSY48JW5"], "rxcui": ["360348"], "spl_set_id": ["2bc57111-0f15-b237-e063-6294a90a4471"], "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": ["Everpharm LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 POUCH in 1 PACKAGE (84415-044-01)  / 1 APPLICATOR in 1 POUCH / .5 mL in 1 APPLICATOR", "package_ndc": "84415-044-01", "marketing_start_date": "20250115"}], "brand_name": "Benzocaine", "product_id": "84415-044_2bc582da-83f3-1644-e063-6294a90a8968", "dosage_form": "SPRAY", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Increased Histamine Release [PE]", "Standardized Chemical Allergen [EPC]"], "product_ndc": "84415-044", "generic_name": "Topical Anesthetic", "labeler_name": "Everpharm LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Benzocaine", "active_ingredients": [{"name": "BENZOCAINE", "strength": "200 mg/mL"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250115", "listing_expiration_date": "20261231"}