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 59 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sting and BiteBENZOCAINEPHOENIX HEALTHCARE SOLUTIONS, LLC82791832-1357-48ca-91d4-1328997012612025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLCa225426a-c4d5-459c-bc11-2b521e08e5102025-10-23WarningsExact identifier
application number: M003
Alcohol SwabsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC1516d90b-4879-eb2f-e063-6294a90aa9142025-10-23WarningsExact identifier
application number: M003
Povidone-Iodine Prep Pads MediumPOVIDONE-IODINEMedline Industries, LP28c05c5c-09d3-2c62-e054-00144ff8d46c2025-10-23WarningsExact identifier
application number: M003
Koala Eco Hand SanitizerETHYL ALCOHOLKoala Eco Company USA Ltd41d7d6e3-9961-770d-e063-6394a90a0d242025-10-23WarningsExact identifier
application number: M003
PROHEAL POVIDONE IODINE PREP PADSPOVIDONE-IODINEClick Industries LLC53733b6c-fa62-43e0-bfcc-3d23b5e1a95a2025-10-23WarningsExact identifier
application number: M003
POVIDONE-IODINEPOVIDONE-IODINEJames Alexander Corporation181a6363-2249-45f0-a28b-79f2c5ffad592025-10-23WarningsExact identifier
application number: M003
American Red Cross AntisepticBENZALKONIUM CHLORIDE 0.13%(W/W)/BENZOCAINE 5.00%(W/W)Zhejiang Guoyao Jingyue Aerosol Co., Ltd.41bbf123-9ff9-5e8a-e063-6394a90af15f2025-10-22WarningsExact identifier
application number: M003
CA-REZZ NORISC ANTIBACTERIAL SKIN CAREBENZETHONIUM CHLORIDEFNC MEDICAL CORPORATIONf93c55f9-b3e1-45f6-8e0d-09e60f5b822f2025-10-22WarningsExact identifier
application number: M003
CA-REZZ - NORISC - INCONTINENT WASHBENZETHONIUM CHLORIDEFNC MEDICAL CORPORATIONed26fa74-5ae8-4294-b61d-682d6ad4b32a2025-10-22WarningsExact identifier
application number: M003
CA-REZZ - LONG TERM CARE - INCONTINENT CLEANSERBENZETHONIUM CHLORIDEFNC MEDICAL CORPORATIONd06b0489-86d3-4bf1-928f-fc524a71560e2025-10-22WarningsExact identifier
application number: M003
Northside Hospital Maternity Backpack-BASEALCOHOL AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLc86458169-92eb-45a5-b3cc-6eccd8caa1e82025-10-22WarningsExact identifier
application number: M003
Northside Hospital Maternity Backpack BASESODIUM MONOFLUOROPHOSPATEALLIANCE FORMULATIONS5d0e768f-086c-4b8c-b618-6dde70f302f92025-10-22WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sea BreezeETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.41a5db85-05b8-ecd6-e063-6394a90ac3872025-10-21WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer StrawBerry ShortCakeETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.41a62d9f-4d46-f8ca-e063-6294a90ae1ed2025-10-21WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Vanilla CloudETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.41a69d10-f7bf-cf17-e063-6294a90a177d2025-10-21WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Watermelon AloeETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.41a7735f-03b7-4fdc-e063-6394a90a100b2025-10-21WarningsExact identifier
application number: M003
American Red Cross 70% Isopropyl AlcoholISOPROPYL ALCOHOL(70%CONC.)Zhejiang Guoyao Jingyue Aerosol Co., Ltd.41b6ee3f-55f4-0502-e063-6394a90aa3572025-10-21WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Tangy TerraneALCOHOLShenzhen Lantern Scicence Co.,Ltd.4192dbc6-5d9a-d42a-e063-6394a90aa2d82025-10-20WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Sweet and StillALCOHOLShenzhen Lantern Scicence Co.,Ltd.41934870-d87e-1c51-e063-6294a90abd2d2025-10-20WarningsExact 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