bactine max

Generic: benzalkonium chloride and lidocaine hydrochloride

Labeler: wellspring pharmaceutical corporation
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name bactine max
Generic Name benzalkonium chloride and lidocaine hydrochloride
Labeler wellspring pharmaceutical corporation
Dosage Form LIQUID
Routes
TOPICAL
Active Ingredients

benzalkonium chloride .13 g/100mL, lidocaine hydrochloride 4 g/100mL

Manufacturer
WellSpring Pharmaceutical Corporation

Identifiers & Regulatory

Product NDC 65197-811
Product ID 65197-811_ec2ae48c-3497-4a66-a88c-4838a37ad3df
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M003
Listing Expiration 2026-12-31
Marketing Start 2018-06-22

Pharmacologic Class

Classes
amide local anesthetic [epc] amides [cs] antiarrhythmic [epc] local anesthesia [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65197811
Hyphenated Format 65197-811

Supplemental Identifiers

RxCUI
2047877 2047879
UPC
0365197811151 0365197811144
UNII
F5UM2KM3W7 V13007Z41A

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 bactine max (source: ndc)
Generic Name benzalkonium chloride and lidocaine hydrochloride (source: ndc)
Application Number M003 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .13 g/100mL
  • 4 g/100mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE, PLASTIC (65197-811-14)
  • 148 mL in 1 BOTTLE (65197-811-15)
source: ndc

Packages (2)

65197-811-14 118 mL in 1 BOTTLE, PLASTIC (65197-811-14) 65197-811-15 148 mL in 1 BOTTLE (65197-811-15)

Ingredients (2)

benzalkonium chloride (.13 g/100mL) lidocaine hydrochloride (4 g/100mL)

Linked Drug Pages (1)

Bactine Max ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "ec2ae48c-3497-4a66-a88c-4838a37ad3df", "openfda": {"upc": ["0365197811151", "0365197811144"], "unii": ["F5UM2KM3W7", "V13007Z41A"], "rxcui": ["2047877", "2047879"], "spl_set_id": ["28e8a311-20a4-45a1-8d5d-ca42b101c275"], "manufacturer_name": ["WellSpring Pharmaceutical Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE, PLASTIC (65197-811-14)", "package_ndc": "65197-811-14", "marketing_start_date": "20210117"}, {"sample": false, "description": "148 mL in 1 BOTTLE (65197-811-15)", "package_ndc": "65197-811-15", "marketing_start_date": "20180622"}], "brand_name": "Bactine Max", "product_id": "65197-811_ec2ae48c-3497-4a66-a88c-4838a37ad3df", "dosage_form": "LIQUID", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Antiarrhythmic [EPC]", "Local Anesthesia [PE]"], "product_ndc": "65197-811", "generic_name": "benzalkonium chloride and lidocaine hydrochloride", "labeler_name": "WellSpring Pharmaceutical Corporation", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Bactine Max", "active_ingredients": [{"name": "BENZALKONIUM CHLORIDE", "strength": ".13 g/100mL"}, {"name": "LIDOCAINE HYDROCHLORIDE", "strength": "4 g/100mL"}], "application_number": "M003", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20180622", "listing_expiration_date": "20261231"}