antiseptic

Generic: benzalkonium chloride, benzocaine

Labeler: safetec of america, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name antiseptic
Generic Name benzalkonium chloride, benzocaine
Labeler safetec of america, inc.
Dosage Form SPRAY
Routes
TOPICAL
Active Ingredients

benzalkonium chloride 1 mg/g, benzocaine 50 mg/g

Manufacturer
Safetec of America, Inc.

Identifiers & Regulatory

Product NDC 61010-5300
Product ID 61010-5300_10d37ff3-97c6-9f55-e063-6294a90a656b
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M003
Listing Expiration 2026-12-31
Marketing Start 2012-02-15

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 610105300
Hyphenated Format 61010-5300

Supplemental Identifiers

RxCUI
1245229
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 antiseptic (source: ndc)
Generic Name benzalkonium chloride, benzocaine (source: ndc)
Application Number M003 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/g
  • 50 mg/g
source: ndc
Packaging
  • 60 g in 1 BOTTLE, SPRAY (61010-5300-0)
  • 90 g in 1 BOTTLE, SPRAY (61010-5300-2)
source: ndc

Packages (2)

61010-5300-0 60 g in 1 BOTTLE, SPRAY (61010-5300-0) 61010-5300-2 90 g in 1 BOTTLE, SPRAY (61010-5300-2)

Ingredients (2)

benzalkonium chloride (1 mg/g) benzocaine (50 mg/g)

Linked Drug Pages (1)

Antiseptic ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "10d37ff3-97c6-9f55-e063-6294a90a656b", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728"], "unii": ["F5UM2KM3W7", "U3RSY48JW5"], "rxcui": ["1245229"], "spl_set_id": ["458e65f2-826d-4550-8c7d-17add2d7ba9a"], "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": ["Safetec of America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 g in 1 BOTTLE, SPRAY (61010-5300-0)", "package_ndc": "61010-5300-0", "marketing_start_date": "20120215"}, {"sample": false, "description": "90 g in 1 BOTTLE, SPRAY (61010-5300-2)", "package_ndc": "61010-5300-2", "marketing_start_date": "20120215"}], "brand_name": "Antiseptic", "product_id": "61010-5300_10d37ff3-97c6-9f55-e063-6294a90a656b", "dosage_form": "SPRAY", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Increased Histamine Release [PE]", "Standardized Chemical Allergen [EPC]"], "product_ndc": "61010-5300", "generic_name": "benzalkonium chloride, benzocaine", "labeler_name": "Safetec of America, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Antiseptic", "active_ingredients": [{"name": "BENZALKONIUM CHLORIDE", "strength": "1 mg/g"}, {"name": "BENZOCAINE", "strength": "50 mg/g"}], "application_number": "M003", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20120215", "listing_expiration_date": "20261231"}