Home NDC 65197-820 BACTINE
Product NDC 65197-820
11-digit product format 651970820
Labeler code 65197
Product ID 65197-820_12dc278f-ffc0-462c-bb13-0bc4bab2f50b
Type HUMAN OTC DRUG
Nonproprietary name Bactine Max Wound Wash
Dosage form LIQUID
Route CUTANEOUS
Labeler WellSpring Pharmaceutical Corporation
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-04-15
Substance BENZALKONIUM CHLORIDE
Active strength .13 g/100mL
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
Brand name suffix MAX
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE .13 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F5UM2KM3W7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1049254 Internal RxNorm lookup 2475353 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65197-820-80 BACTINEMAX 1 in 1 CARTON LIQUID 1 7 65197-820-80 BACTINEMAX 236 mL in 1 BOTTLE LIQUID 236 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65197-820 BACTINE MAX (BACTINE MAX WOUND WASH) LIQUID [WELLSPRING PHARMACEUTICAL CORPORATION] 7 Current NDC, Legacy NDC, 2 package rows 20250110_39b26c28-93e0-41a9-8018-f73525ebc015.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 101 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 65197-820-80 65197082080 1 BOTTLE in 1 CARTON (65197-820-80) / 236 mL in 1 BOTTLE 1 bottle 2023-04-15 0000-00-00 No No Current