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 51 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dceced03-eeb8-fced-e053-2995a90afd5c2025-12-06WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dced643b-96fb-193f-e053-2a95a90a16aa2025-12-06WarningsExact identifier
application number: M003
Betadine Foam CleanserBENZALKONIUM CHLORIDEAtlantis Consumer Healthcare, Inc.3be9fa6e-3ae8-496b-876b-f81f1cd98af42025-12-05WarningsExact identifier
application number: M003
2XL Mega Rolls Sanitizing WipesBENZALKONIUM CHLORIDE2xl Corporation9da541ab-6836-4149-a86d-3b2f2e5866282025-12-05WarningsExact identifier
application number: M003
Hand WipesBENZALKONIUM CHLORIDEAdvanced Ultrasound Solutions Inc.2c2abaa8-c152-470b-a4d9-5056815a19872025-12-05WarningsExact identifier
application number: M003
Benzalkonium ChlorideSANITIZING HAND WIPESALO NEW YORK LLCd3d95355-3af7-43e3-e053-2a95a90a0fa42025-12-05WarningsExact identifier
application number: M003
Giant Eagle Antibacterial Hand WipesBENZALKONIUM CHLORIDEGiant Eaglee20e9a93-03c3-77f8-e053-2995a90ae59f2025-12-05WarningsExact identifier
application number: M003
Antibacterial WipesBENZALKONIUM CHLORIDEERC Acquisition, Incdc6c39af-447c-481a-98b5-33b8f09b83bc2025-12-05WarningsExact identifier
application number: M003
Sanitex Antibacterial Hand Wipes Fresh ScentBENZALKONIUM CHLORIDEPrecare Corp48907146-ca66-46e1-928b-a8f968a6bff82025-12-05WarningsExact identifier
application number: M003
Benzalkonium ChlorideANTIBACTERIAL HAND WIPESQuest USA Corpd9ab219d-07e3-2019-e053-2a95a90a16682025-12-05WarningsExact identifier
application number: M003
Benzalkonium ChlorideDUAL ACTION ANTIBACTERIAL WIPESAvro Enterprises LLCcf42e470-19c8-2e11-e053-2995a90ae90d2025-12-05WarningsExact identifier
application number: M003
Benzalkonium ChlorideDUAL ACTION ANTIMICROBIAL WIPESAvro Enterprises LLCcf4680f4-24b2-1242-e053-2a95a90a93742025-12-05WarningsExact identifier
application number: M003
Benzalkonium ChlorideANTIBACTERIAL HAND WIPESTarget Corporationf6037707-c6bb-11a0-e053-2995a90acce82025-12-05WarningsExact identifier
application number: M003
Sanitizing WipesBENZALKONIUM CHLORIDEZogics, LLC2cd916ee-dc6d-49e4-a9b5-06ad4b2b054d2025-12-05WarningsExact identifier
application number: M003
GELLE-N-DETOX - LAVENDER AND ROSEMARY MASSAGEBENZALKONIUM CHLORIDECHEMCO CORPORATIONf28c2c1e-7d0a-45b9-e053-2995a90a47102025-12-05WarningsExact identifier
application number: M003
GELLE-N-DETOX ICE MINT AND EUCALYPTUS MASSAGEBENZALKONIUM CHLORIDECHEMCO CORPORATIONf2a107aa-5ad3-7bad-e053-2a95a90a1d972025-12-05WarningsExact identifier
application number: M003
PROHEAL POVIDONE IODINE SWABSTICKPOVIDONE-IODINEClick Industries LLC974e1205-01ab-4599-9229-cdf5225d268a2025-12-03WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Jasmine GardeniaALCOHOLShenzhen Lantern Scicence Co.,Ltd.45082749-6f53-c595-e063-6294a90ac3e92025-12-03WarningsExact identifier
application number: M003
ALCOHOL PREP PAD70% ISOPROPY ALCOHOL SWABPurCel Labs LLC450c39fd-d172-492e-e063-6294a90aa3962025-12-03WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERDynarex Corporation450e56f0-b8ae-072a-e063-6394a90a2d4b2025-12-03WarningsExact 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