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 111 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Povidone IodinePOVIDONE IODINE GARGLE 0.5%Humco Holding Group, Inc.a7b9ad55-cfeb-6066-e053-2a95a90af9752023-12-15WarningsExact identifier
application number: M003
Rite Aid Povidone IodinePOVIDONE IODINE 10%Rite Aid Corporation5df6ff37-a4ea-d666-e053-2991aa0a97862023-12-15WarningsExact identifier
application number: M003
Rite Aid Decolorized IodineETHYL ALCOHOLRite Aid Corporation5e0d3664-b02a-ba28-e053-2991aa0a8a4c2023-12-15WarningsExact identifier
application number: M003
De La Cruz Tincture of IodineIODINE AND SODIUM IODIDE AND ALCOHOLDLC Laboratories, Inc.5d8f60a9-6d1c-0b0f-e053-2991aa0a8a9b2023-12-15WarningsExact identifier
application number: M003
ALCOHOL ANTISEPTIC HAND SANITIZER ANTIBACTERIALALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.0c73f4f5-2b1d-84ae-e063-6394a90a5d7b2023-12-14WarningsExact identifier
application number: M003
TaeTu AftercareBENZALKONIUM CHLORIDETaetu LLCdec15a4d-1a33-a78a-e053-2995a90a69fe2023-12-14WarningsExact identifier
application number: M003
GNP Idoinde Tincture 2% MildIODINE AND SODIUM IODIDE AND ALCOHOLAmerisource Bergen32ad75b8-abd1-4151-a035-b6c9ae5fc8882023-12-14WarningsExact identifier
application number: M003
Antibacterial Wet WipesBENZALKONIUM CHLORIDEHangZhou YangYi Daily Cosmetics Technology Co., Ltd.85d3914d-dbb8-5036-e053-2a91aa0a7cd42023-12-13WarningsExact identifier
application number: M003
AntiochPharma Rapidgel Hand SanitizerALCOHOLWeeks & Leo0c57a9ea-de66-3ced-e063-6294a90a4b8d2023-12-12WarningsExact identifier
application number: M003
antiseptic hand sanitizer 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.e9f9b7b6-fed7-10e1-e053-2a95a90a9aa62023-12-11WarningsExact identifier
application number: M003
AntiochPharma Hand SanitizerALCOHOLWeeks & Leoa1a0d368-b004-59b8-e053-2995a90ab4b12023-12-11WarningsExact identifier
application number: M003
Septihol Hand SanitizerALCOHOLSTERIS Corporation279c5c6f-bf45-499f-a5a2-ddb5353821462023-12-06WarningsExact identifier
application number: M003
Zany Antiseptic GelALCOHOLLaboratorios Zepol S.A.ee085cb5-0ebf-498c-b622-b2c29d34bb9b2023-12-01WarningsExact identifier
application number: M003
Prep Pad SterilePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd758abf53-ad8a-62ac-e053-2991aa0a8f0c2023-11-15WarningsExact identifier
application number: M003
FIRSTAR Alcohol Prep PadISOPROPYL ALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.49a86020-b888-423f-99a5-02fa938105ec2023-11-15WarningsExact identifier
application number: M003
CVS Health Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLCVS Health4678074a-16f1-5480-e054-00144ff8d46c2023-11-10WarningsExact identifier
application number: M003
Care One 70 Isopropyl Alcohol WipesISOPROPYL ALCOHOLAhold U.S.A., Inc.607b6917-2880-4b1c-83c6-f1297a828ecc2023-11-10WarningsExact identifier
application number: M003
Topcare 3 Hydrogen Peroxide WipesHYDROGEN PEROXIDETopco Associates LLCdc4b07b6-6476-4e32-901a-da8115d6a1972023-11-10WarningsExact identifier
application number: M003
Topcare 70 Isopropyl Alcohol WipesISOPROPYL ALCOHOLTopco Associates LLCbf9ee7da-69d9-47a2-8748-6b978ca3c2982023-11-10WarningsExact identifier
application number: M003
MK Alcohol Swabstick SterileISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd40c7cfc6-ef3b-4759-b9e9-6d7e1319a8472023-11-09WarningsExact 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