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 89 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Up and Up Max Pain Relieving CleansingBENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDETARGET CORPORATION2c3e72eb-5d98-1f3f-e063-6394a90ab00c2025-01-21WarningsExact identifier
application number: M003
Sierrasoft Clear Antibacterial Wash FoamCHLOROXYLENOLCWGC LA Inc.013a36fa-5a9a-46ea-b9d0-ac366257612e2025-01-20WarningsExact identifier
application number: M003
TM TITUS MEDICAL ANTISEPTIC Non SterilePOVIDONE-IODINETitus Medical LLC690b87d0-d889-43c6-b99e-cd9f26fd682a2025-01-17WarningsExact identifier
application number: M003
TM Titus Medical Povidone IodinePOVIDONE-IODINETitus Medical LLCaf7840c0-239e-4ff6-8d27-614e7d71ca992025-01-17WarningsExact identifier
application number: M003
Smart Care Sanitizer Spray. 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1b125c5d-7041-c71b-e063-6394a90add9b2025-01-17WarningsExact identifier
application number: M003
Berry Hand Sanitizer Spray. 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1f128054-4c57-8055-e063-6294a90adc4e2025-01-17WarningsExact identifier
application number: M003
ROAME Moisturizing Hand Sanitizer Cloud 999ALCOHOL HAND SANITIZERRoame LLC2bb1003e-8e4c-8dd8-e063-6294a90ad37d2025-01-14WarningsExact identifier
application number: M003
Antiseptic TowelettesBENZALKONIUM CHLORIDECMC Group Inc.d7470f98-4278-415b-92e7-9eca2036bc092025-01-13WarningsExact identifier
application number: M003
Alcohol CleansingISOPROPYL ALCOHOLCMC Group Inc.e3985ef1-503a-4193-a5b5-7910aefa78142025-01-13WarningsExact identifier
application number: M003
Antibiotic ApplicationBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATECMC Group, Inc.da436c35-a98f-4df7-9d23-885564734cef2025-01-13WarningsExact identifier
application number: M003
Burn TreatmentBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDECMC Group Inc.9dd56b66-48c0-4bcf-a9a8-ba2f1e11ce402025-01-13WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLCMC Group Inc.dcca50e6-0935-401d-a23e-be4d1231dde92025-01-13WarningsExact identifier
application number: M003
Refill 2BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATECMC Group, Inc.45dde3f0-546c-4ec5-beb0-c3d0432f49832025-01-13WarningsExact identifier
application number: M003
Refill 3BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDECMC Group Inc.e5cb395f-5037-4b0e-9c9d-2d78b5b01b252025-01-13WarningsExact identifier
application number: M003
Refill 4ISOPROPYL ALCOHOLCMC Group Inc.6f4a4538-7522-4bcf-b3cf-8dea60438a4d2025-01-13WarningsExact identifier
application number: M003
Refill 6ALCOHOL, WATERCMC Group, Inc.7849ae59-5484-4b86-a0b9-ec9b93d9afe02025-01-13WarningsExact identifier
application number: M003
EVR Povidone lodine WipePOVIDONE LODINEChangzhou Maokang Medical Products Co., Ltd.2b57e301-74e0-e1db-e063-6294a90a6c182025-01-10WarningsExact identifier
application number: M003
EVR Sting Relief WipeBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd.2b584d09-916c-00f8-e063-6294a90adbcf2025-01-10WarningsExact identifier
application number: M003
Medzah Ditek Alcohol Prep PadsISOPROPYL ALCOHOLMedzah Industries4e6e5b6b-147c-4e7c-9b8c-6a3116c4bdac2025-01-10WarningsExact identifier
application number: M003
Alcohol Prep Pad-LargeISOPROPYL ALCOHOLGlobal Biomedical Technologies, LLC93d00515-e93f-48a3-b66b-7d933e734e542025-01-10WarningsExact 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