FDA.reportPublic FDA data

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
IngredientStrength
BENZALKONIUM CHLORIDE.13 g/100mL
LIDOCAINE HYDROCHLORIDE4 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup
V13007Z41AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2047877Internal RxNorm lookup
2047879Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
28e8a311-20a4-45a1-8d5d-ca42b101c275Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65197-811-14Bactine Max118 mL in 1 BOTTLE, PLASTICLIQUID1189
65197-811-15Bactine Max148 mL in 1 BOTTLELIQUID1489

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65197-811BACTINE MAX (BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE) LIQUID [WELLSPRING PHARMACEUTICAL CORPORATION]9Current NDC, Legacy NDC, 2 package rows20250110_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 105 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Novex Hand SanitizerBENZALKONIUM CHLORIDENatural Essentials, Inc.8b53dde5-c9f6-41c4-8ddb-bf0bf67008d32024-03-20WarningsExact identifier
application number: M003
AntisepticBENZALKONIUM CHLORIDE 0.13%Trifecta Pharmaceuticals USA, LLC.13f1c70f-3b44-8eef-e063-6294a90af6342024-03-18WarningsExact identifier
application number: M003
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCITrifecta Pharmaceuticals USA LLC1308ce91-2858-310a-e063-6394a90a68102024-03-06WarningsExact identifier
application number: M003
Instant Hand Sanitizer - Cocoa ButterETHYL ALCOHOLRejoice International, Inc.97dee45e-53be-4b37-a427-fc24388c0e052024-02-28WarningsExact identifier
application number: M003
Instant Hand Sanitizer Aloe VeraETHYL ALCOHOLRejoice International, Inc.1e28454c-f5d8-4d6e-91f9-bc4501b027c12024-02-28WarningsExact identifier
application number: M003
Instant Hand Sanitizer - ClearETHYL ALCOHOLRejoice International, Inc.f0e637d9-d61e-466d-9e05-f906639dbaca2024-02-28WarningsExact identifier
application number: M003
Instant Hand SanitizerETHYL ALCOHOLRejoice International, Inc.07b163e4-8f67-44e7-b5ef-f237023080e02024-02-28WarningsExact identifier
application number: M003
Instant Hand Sanitizer - Ice ClearETHYL ALCOHOLRejoice International, Inc.605ec88a-2f4c-4716-8522-eb2748b433982024-02-28WarningsExact identifier
application number: M003
Instant Hand Sanitizer - OriginalETHYL ALCOHOLRejoice International, Inc.bb9cc886-275e-4996-99dc-529f928b49052024-02-28WarningsExact identifier
application number: M003
Liquid Hand CleanseTRICLOSANRejoice International, Inc.23ff5450-8308-41c0-9052-1ac4c4433d6c2024-02-28WarningsExact identifier
application number: M003
XtraCare Antibacterial Hand Cleanse OriginalTRICLOSANRejoice International, Inc.b5ce6663-fe82-4da1-923e-acea293d7a002024-02-28WarningsExact identifier
application number: M003
XtraCare Antibacterial Hand Cleanse Strawberry PomegranateTRICLOSANRejoice International, Inc.b68a7d64-2650-4fc6-a89e-05de9098a2a32024-02-28WarningsExact identifier
application number: M003
XtraCare Antibacterial Hand Cleanse Mountain SpringTRICLOSANRejoice International, Inc.c31723d5-a313-448a-8b69-ca5f8dec25ed2024-02-28WarningsExact identifier
application number: M003
XtraCare Foam Antibacterial Hand Wash Pink Cherry BlossomBENZALKONIUM CHLORIDERejoice Internationala9a1467c-abcc-4ccb-88f6-4302796097882024-02-28WarningsExact identifier
application number: M003
XtraCare Foam Antibacterial Hand Wash Refill Pink Cherry BlossomBENZALKONIUM CHLORIDERejoice International9fa9d955-7167-4a0a-935b-2a600f439eb02024-02-28WarningsExact identifier
application number: M003
XtraCare Foam Antibacterial Hand Wash Refill Vanilla Passion FlowerBENZALKONIUM CHLORIDERejoice International157a14bf-f46e-49f8-96f4-a6c472eb5cb82024-02-28WarningsExact identifier
application number: M003
XtraCare Foaming Hand SanitizerBENZALKONIUM CHLORIDERejoice International3082cbbb-a0ed-45eb-a116-ad1c65357dd12024-02-28WarningsExact identifier
application number: M003
XtraCare Foam Antibacterial Hand Wash Refill Wild Berry BlastBENZALKONIUM CHLORIDERejoice International45b3ca49-edb4-4840-b857-d24045494a3a2024-02-28WarningsExact identifier
application number: M003
XtraCare Foam Antibacterial Hand Wash Vanilla Passion FlowerBENZALKONIUM CHLORIDERejoice International4890f81e-7994-4ea2-9412-5614c405a2a32024-02-28WarningsExact identifier
application number: M003
XtraCare Foam Antibacterial Hand Wash Wild Berry BlastBENZALKONIUM CHLORIDERejoice International5c109f7c-1f4d-484a-b6ea-3bbcf572bbac2024-02-28WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2047879Bactine MAX 0.13 % / 4 % Topical SprayPSN28e8a311-20a4-45a1-8d5d-ca42b101c2759
2047877benzalkonium chloride 0.13 % / lidocaine HCl 4 % Topical SprayPSN28e8a311-20a4-45a1-8d5d-ca42b101c2759
2047879benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 40 MG/ML Topical Spray [Bactine]SBD28e8a311-20a4-45a1-8d5d-ca42b101c2759
2047877benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 40 MG/ML Topical SpraySCD28e8a311-20a4-45a1-8d5d-ca42b101c2759
2047879Bactine (benzalkonium chloride 0.13 % / lidocaine hydrochloride 4 % ) Topical SpraySY28e8a311-20a4-45a1-8d5d-ca42b101c2759
2047879Bactine (benzalkonium chloride 1.3 MG / lidocaine hydrochloride 40 MG) per ML Topical SpraySY28e8a311-20a4-45a1-8d5d-ca42b101c2759
2047877benzalkonium chloride 0.13 % / lidocaine HCl 4 % Topical SpraySY28e8a311-20a4-45a1-8d5d-ca42b101c2759

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65197-811-1465197081114118 mL in 1 BOTTLE, PLASTIC (65197-811-14) 118 ml2021-01-170000-00-00NoNoCurrent
65197-811-1565197081115148 mL in 1 BOTTLE (65197-811-15) 148 ml2018-06-220000-00-00NoNoCurrent