FDA.reportPublic FDA data

Inverness EAR CARE ANTISEPTIC

Product NDC
70094-010
11-digit product format
700940010
Labeler code
70094
Product ID
70094-010_2e5ccc2b-87f0-e1ca-e063-6294a90a6ac1
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
SOLUTION
Route
TOPICAL
Labeler
The Richline Group
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-06-04
Substance
BENZALKONIUM CHLORIDE
Active strength
1.2 mg/mL
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
Inverness EAR CARE ANTISEPTIC
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1.2 mg/mL

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1052949Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ac42d2f1-69e3-45f6-8002-d45ebed5ee22Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70094-010-022020-01-31C16284748780-19d75b9cf-dd09-f424-e053-dadaa90a57ceInverness EAR CARE ANTISEPTIC
70094-010-042020-01-31C16284748780-19d75b9cf-dd09-f424-e053-dadaa90a57ceInverness EAR CARE ANTISEPTIC
70094-010-082020-01-31C16284748780-19d75b9cf-dd09-f424-e053-dadaa90a57ceInverness EAR CARE ANTISEPTIC

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70094-010-02Inverness EAR CARE ANTISEPTIC60 mL in 1 BOTTLESOLUTION607
70094-010-04Inverness EAR CARE ANTISEPTIC118 mL in 1 BOTTLESOLUTION1187
70094-010-08Inverness EAR CARE ANTISEPTIC236 mL in 1 BOTTLESOLUTION2367

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70094-010INVERNESS EAR CARE ANTISEPTIC (BENZALKONIUM CHLORIDE) SOLUTION [THE RICHLINE GROUP]7Current NDC, 3 package rows20250221_ac42d2f1-69e3-45f6-8002-d45ebed5ee22.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 107 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand sanitizer 8oz with aloe veraETHYL ALCOHOL 70%V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.0fbd6962-59e6-7230-e063-6394a90afd8e2024-01-24WarningsExact identifier
application number: M003
Cold Sore Treatment, 24-7 Life by 7-ElevenBENZALKONIUM CHLORIDELil' Drug Store Products, Inc.0f4fb868-1462-f88e-e063-6394a90a69e42024-01-19WarningsExact identifier
application number: M003
Medi-First Burn with LidocaineBENZALKONIUM CHLORIDE, LIDOCAINEUnifirst First Aid Corporationbd46efc8-0b36-0931-e053-2a95a90adb6f2024-01-17WarningsExact identifier
application number: M003
Green Guard AntisepticBENZALKONIUM CHLORIDEUnifirst First Aid Corporationbc914c36-e0f0-18c5-e053-2a95a90a894e2024-01-17WarningsExact identifier
application number: M003
Medi-First Hydrogen PeroxideHYDROGEN PEROXIDEUnifirst First Aid Corporationbca2b641-7fbc-5462-e053-2995a90ae2b42024-01-17WarningsExact identifier
application number: M003
Medi-First Isopropyl Alcohol 70%ISOPROPYL ALCOHOLUnifirst First Aid Corporationdbeac2f5-b897-5e71-e053-2995a90a75492024-01-17WarningsExact identifier
application number: M003
Green Guard Hydrogen PeroxideHYDROGEN PEROXIDEUnifirst First Aid Corporationbca4545e-d477-270a-e053-2995a90a0ed62024-01-17WarningsExact identifier
application number: M003
MyMedic Calendula GelCALENDULA OFFICINALIS FLOWERNantong Health & Beyond Hygienic Products Inc.0f0aa235-ac35-ac91-e063-6394a90a73fc2024-01-16WarningsExact identifier
application number: M003
MyMedic Oral Pain Relief GelBENZOCAINENantong Health & Beyond Hygienic Products Inc.0f0b6157-ec18-13ef-e063-6294a90a2e0c2024-01-16WarningsExact identifier
application number: M003
MyMedic Super SanitizerETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.0f0c535d-8ff3-4799-e063-6394a90a70632024-01-16WarningsExact identifier
application number: M003
MyMedic Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.0f0d1ba7-fe9c-8e0b-e063-6394a90a30812024-01-16WarningsExact identifier
application number: M003
White PetrolatumWHITE PETROLATUMNantong Health & Beyond Hygienic Products Inc.0f0d6ff0-ff30-aaf8-e063-6394a90a27162024-01-16WarningsExact identifier
application number: M003
Thompson Hand SanitizerETHYL ALCOHOLThompsondeada606-8a82-9eeb-e053-2a95a90a9e6d2024-01-16WarningsExact identifier
application number: M003
MyMedic Arnica GelARNICA MONTANANantong Health & Beyond Hygienic Products Inc.0ef8760d-27c0-7ece-e063-6294a90a68732024-01-15WarningsExact identifier
application number: M003
American Safety First Aid AntispeticHYDROGEN PEROXIDEOrazen Incea2fbdfe-1932-9fb4-e053-2a95a90a35632024-01-15WarningsExact identifier
application number: M003
First Aid AntispeticBENZALKONIUM CHLORIDEOrazen Incea2debcb-892c-339f-e053-2a95a90a4b182024-01-15WarningsExact identifier
application number: M003
Ever Ready First AidBENZALKONIUM CHLORIDE, LIDOCAINE HCIEver Ready First Aide53f3bf5-25c0-2b86-e053-2a95a90a010f2024-01-15WarningsExact identifier
application number: M003
FIRST SHIELD First Aid AntisepticBENZALKONIUM CHLORIDEEver Ready First Aide013ef0a-ef3d-7af5-e053-2a95a90a54d32024-01-15WarningsExact identifier
application number: M003
Latalia Hand Sanitizer 80 Alcohol AntisepticALCOHOLINTERNATIONAL CONSUMER PRODUCTS (PVT.) LTDae55fab3-3177-383e-e053-2995a90a17a02024-01-10WarningsExact identifier
application number: M003
Latalia Sanitizing WipeALCOHOLINTERNATIONAL CONSUMER PRODUCTS (PVT.) LTDae564635-898e-fbf6-e053-2995a90a81192024-01-10WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1052949benzalkonium chloride 0.12 % Topical SolutionPSNac42d2f1-69e3-45f6-8002-d45ebed5ee227
1052949benzalkonium chloride 1.2 MG/ML Topical SolutionSCDac42d2f1-69e3-45f6-8002-d45ebed5ee227
1052949benzalkonium chloride 0.12 % Topical SolutionSYac42d2f1-69e3-45f6-8002-d45ebed5ee227

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70094-010-027009400100260 mL in 1 BOTTLE (70094-010-02) 60 ml2014-06-04NoNoCurrent
70094-010-0470094001004118 mL in 1 BOTTLE (70094-010-04) 118 ml2014-06-04NoNoCurrent
70094-010-0870094001008236 mL in 1 BOTTLE (70094-010-08) 236 ml2014-06-04NoNoCurrent