Home NDC 65197-811 Bactine Max
Product NDC 65197-811
11-digit product format 651970811
Labeler code 65197
Product ID 65197-811_ec2ae48c-3497-4a66-a88c-4838a37ad3df
Type HUMAN OTC DRUG
Nonproprietary name benzalkonium chloride and lidocaine hydrochloride
Dosage form LIQUID
Route TOPICAL
Labeler WellSpring Pharmaceutical Corporation
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-06-22
Substance BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE
Active strength .13; 4 g/100mL; g/100mL
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Bactine Max
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE .13 g/100mL LIDOCAINE HYDROCHLORIDE 4 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F5UM2KM3W7 Internal UNII lookup V13007Z41A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2047877 Internal RxNorm lookup 2047879 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65197-811-14 Bactine Max 118 mL in 1 BOTTLE, PLASTIC LIQUID 118 9 65197-811-15 Bactine Max 148 mL in 1 BOTTLE LIQUID 148 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65197-811 BACTINE MAX (BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE) LIQUID [WELLSPRING PHARMACEUTICAL CORPORATION] 9 Current NDC, Legacy NDC, 2 package rows 20250110_28e8a311-20a4-45a1-8d5d-ca42b101c275.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 9 of 115 · 2,286 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 65197-811-14 65197081114 118 mL in 1 BOTTLE, PLASTIC (65197-811-14) 118 ml 2021-01-17 0000-00-00 No No Current 65197-811-15 65197081115 148 mL in 1 BOTTLE (65197-811-15) 148 ml 2018-06-22 0000-00-00 No No Current