americaine

Generic: benzocaine

Labeler: insight pharmaceuticals llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name americaine
Generic Name benzocaine
Labeler insight pharmaceuticals llc
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

benzocaine 5.6 g/28g

Manufacturer
Insight Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 63736-375
Product ID 63736-375_41746b33-0ff3-4b02-8018-34e4fd54ef7b
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M015
Listing Expiration 2026-12-31
Marketing Start 2009-07-10

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 63736375
Hyphenated Format 63736-375

Supplemental Identifiers

RxCUI
244557 1426293
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 americaine (source: ndc)
Generic Name benzocaine (source: ndc)
Application Number M015 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 5.6 g/28g
source: ndc
Packaging
  • 1 TUBE in 1 BOX (63736-375-01) / 28 g in 1 TUBE
source: ndc

Packages (1)

63736-375-01 1 TUBE in 1 BOX (63736-375-01) / 28 g in 1 TUBE

Ingredients (1)

benzocaine (5.6 g/28g)

Linked Drug Pages (1)

Americaine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "41746b33-0ff3-4b02-8018-34e4fd54ef7b", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728"], "unii": ["U3RSY48JW5"], "rxcui": ["244557", "1426293"], "spl_set_id": ["d13c022f-2f91-40b4-bd66-0cfc0e147a5f"], "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": ["Insight Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 BOX (63736-375-01)  / 28 g in 1 TUBE", "package_ndc": "63736-375-01", "marketing_start_date": "20090710"}], "brand_name": "Americaine", "product_id": "63736-375_41746b33-0ff3-4b02-8018-34e4fd54ef7b", "dosage_form": "OINTMENT", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Increased Histamine Release [PE]", "Standardized Chemical Allergen [EPC]"], "product_ndc": "63736-375", "generic_name": "Benzocaine", "labeler_name": "Insight Pharmaceuticals LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Americaine", "active_ingredients": [{"name": "BENZOCAINE", "strength": "5.6 g/28g"}], "application_number": "M015", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20090710", "listing_expiration_date": "20261231"}