FDA.reportPublic FDA data

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
IngredientStrength
BENZALKONIUM CHLORIDE.13 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049254Internal RxNorm lookup
2475353Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
39b26c28-93e0-41a9-8018-f73525ebc015Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65197-820-80BACTINEMAX1 in 1 CARTONLIQUID17
65197-820-80BACTINEMAX236 mL in 1 BOTTLELIQUID2367

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65197-820-80ML - Milliliter65197-8202735ed83-b325-48b5-808d-3f2390edfc1412022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65197-820BACTINE MAX (BACTINE MAX WOUND WASH) LIQUID [WELLSPRING PHARMACEUTICAL CORPORATION]7Current NDC, Legacy NDC, 2 package rows20250110_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 4 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gentian VioletGENTIAN VIOLETVitamex USA, Corp21742061-fc0b-f750-e063-6394a90a75082026-08-26WarningsExact identifier
application number: M003
MercurochromeBENZALKONIUM CHLORIDEVitamex USA, Corp21652b11-715d-0c54-e063-6294a90a88552026-08-26WarningsExact identifier
application number: M003
Scentsational Square Hand SanitizerHAND SANITIZERRaining Rose, Inc.59f9bacf-80dc-3468-e063-6294a90a0ae12026-08-26WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59fa27b4-dfd4-720b-e063-6394a90af6592026-08-26WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59fb22d6-f6a4-42cd-e063-6394a90a859a2026-08-26WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59fbb054-461e-aa6e-e063-6394a90a470c2026-08-26WarningsExact identifier
application number: M003
Curad Alcohol Sterile, ThickISOPROPYL ALCOHOLMedline Industries, LPb769898e-a73f-4323-af15-bee8dbe455b62026-08-25WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEYour Military Exchangesa71734c6-6b92-4d3d-84d1-a07f592fa8282026-08-25Warnings, Adverse reactionsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59e742a6-61f9-59f7-e063-6394a90a87382026-08-25WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59e7dfb1-49b5-d2be-e063-6394a90a04d82026-08-25WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59d3c369-86aa-8ebd-e063-6394a90aa8062026-08-24WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59d7fc3c-3a93-153d-e063-6394a90ac6472026-08-24WarningsExact identifier
application number: M003
Be Smart Get Prepared Hand SanitizerALCOHOLTotal Resources International, Inc23d0dc62-28d6-4d1f-a7d5-4b14f5c9fb1e2026-08-24WarningsExact identifier
application number: M003
ClaravieBENZALKONIUM CHLORIDEGentell LLC59887af3-9b22-9664-e063-6294a90a57c62026-08-21WarningsExact identifier
application number: M003
hand sanitizer- light blue 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598a96f0-33fe-40aa-e063-6394a90aeacb2026-08-21WarningsExact identifier
application number: M003
hand sanitizer- light green 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598a165a-90ff-e00c-e063-6394a90a33512026-08-21WarningsExact identifier
application number: M003
Family Beauty Antibacterial Hand WipesBENZALKONIUM CHLORIDEZhejiang Bright Care Co., Ltd.6ff604f7-4011-4f0e-aa2d-a46e1a973d132026-08-21WarningsExact identifier
application number: M003
hand sanitizer- light purple 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598b7bb8-0d2e-a66f-e063-6294a90a45b82026-08-21WarningsExact identifier
application number: M003
hand sanitizer- light yellow 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598bf8cd-2a79-8b56-e063-6394a90a42a82026-08-21WarningsExact identifier
application number: M003
hand sanitizer- light pink 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598c41f0-908d-df52-e063-6394a90a3c8d2026-08-21WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2475353Bactine Wound Wash 0.13 % Topical SolutionPSN39b26c28-93e0-41a9-8018-f73525ebc0157
1049254benzalkonium chloride 0.13 % Topical SolutionPSN39b26c28-93e0-41a9-8018-f73525ebc0157
2475353benzalkonium chloride 1.3 MG/ML Topical Solution [Bactine Wound Wash]SBD39b26c28-93e0-41a9-8018-f73525ebc0157
1049254benzalkonium chloride 1.3 MG/ML Topical SolutionSCD39b26c28-93e0-41a9-8018-f73525ebc0157
2475353Bactine Wound Wash 0.13 % Topical SolutionSY39b26c28-93e0-41a9-8018-f73525ebc0157
2475353Bactine Wound Wash 1.3 MG/ML Topical SolutionSY39b26c28-93e0-41a9-8018-f73525ebc0157
1049254benzalkonium chloride 0.13 % Topical SolutionSY39b26c28-93e0-41a9-8018-f73525ebc0157

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65197-820-80651970820801 BOTTLE in 1 CARTON (65197-820-80) / 236 mL in 1 BOTTLE1 bottle2023-04-150000-00-00NoNoCurrent