FDA.reportPublic FDA data

Inverness Hygienic Ear Care Antiseptic

Product NDC
70094-005
11-digit product format
700940005
Labeler code
70094
Product ID
70094-005_165eb4d0-2961-a12a-e063-6394a90ac24d
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
SOLUTION
Route
TOPICAL
Labeler
The Richline Group, Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-01
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 Hygienic 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
0ccd72e7-16a2-47c7-9ce6-dffb63a0344bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70094-005-03Inverness Home Ear Piercing Kit60 mL in 1 BOTTLESOLUTION60 mL1.2 mg in 1mL2
70094-005-03Inverness Home Ear Piercing Kit1 in 1 BOXSOLUTION1.2 mg in 1mL2
70094-005-01Inverness Hygienic Ear Care Antiseptic60 mL in 1 BOTTLESOLUTION601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70094-005INVERNESS HOME EAR PIERCING KIT (BENZALKONIUM CHLORIDE) KIT [THE RICHLINE GROUP, INC.]2Current NDC20250221_80909a34-21da-4c54-bb62-fd986fd24b04.zip
70094-005INVERNESS HYGIENIC EAR CARE ANTISEPTIC (BENZALKONIUM CHLORIDE) SOLUTION [THE RICHLINE GROUP, INC.]1Current NDC, 1 package rows20240501_0ccd72e7-16a2-47c7-9ce6-dffb63a0344b.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 30 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand SanitizerALCOHOLTrifecta Pharmaceuticals USA0ba469a8-53f3-eb8e-e063-6294a90a1efc2026-03-04WarningsExact identifier
application number: M003
Isopropyl alcohol 91 percent ReadyInCaseISOPROPYL ALCOHOLP & L Development, LLCa6d2068f-705d-4341-b1c8-81e1b563ab9a2026-03-04WarningsExact identifier
application number: M003
50% Isopropyl AlcoholISOPROPYL ALCOHOLAmazon.com Services LLC95e31119-8487-4bc9-b1c2-c43d32fc80ce2026-03-03Warnings, Adverse reactionsExact identifier
application number: M003
FOOTSPA PEDIALCOHOLCHEMCO CORPORATION3886a958-d035-ed15-e063-6294a90af1b52026-03-03WarningsExact identifier
application number: M003
Medicated Apricot ScrubSALICYLIC ACIDOld East Main Co.7c9c430b-30d8-4642-85bd-d028a9aa748a2026-03-02Warnings, Adverse reactionsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINEOld East Main Co.fb9bbb51-d131-42b4-94e6-b752595b10812026-03-02WarningsExact identifier
application number: M003
IsopropylISOPROPYL ALCOHOLOld East Main Co.ea6f3065-780e-4afc-a361-a2cb296ae4d52026-03-02Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLOld East Main Co.2a09f6c0-e9a6-4f48-bce1-6cf7345f2d872026-03-02Warnings, Adverse reactionsExact identifier
application number: M003
70%ISOPROPYL ALCOHOLOld East Main Co.3e7a7f3e-3e99-4999-95c2-1603aca08e892026-03-02Warnings, Adverse reactionsExact identifier
application number: M003
50% RubbingISOPROPYL ALCOHOLOld East Main Co.2b600254-2a70-4254-85fb-29b9adb56c9a2026-03-02Warnings, Adverse reactionsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEOld East Main Co.3c823b47-2ab7-4002-9b6f-abf0a3176b442026-03-02Warnings, Adverse reactionsExact identifier
application number: M003
American Red Cross 6oz, 3% Hydrogen PeroxideAMERICAN RED CROSS 6 OZ, 3% HYDROGEN PEROXIDE SPRAYMY IMPORTS USA LLC29299c46-a929-0d92-e063-6294a90a42182026-03-02WarningsExact identifier
application number: M003
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLTARGET Corporationc49f46c5-f9b2-4045-a31d-63cb222102332026-03-02WarningsExact identifier
application number: M003
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLSam's West, Inca9d6778a-e5ad-4e02-9142-4a932540eda72026-03-02WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEChain Drug Marketing Association31e7063e-0ba1-434f-b404-0ec42df634a32026-02-27Warnings, Adverse reactionsExact identifier
application number: M003
Iodine TinctureIODINE TINCTUREThe Kroger Co.c70a718f-d51a-455a-9785-ab41c1b1f8b02026-02-27Warnings, Adverse reactionsExact identifier
application number: M003
MedPride SterileBENZALKONIUM CHLORIDEShield Line LLC02f63d50-e4ff-49b6-9f8c-fddceefe65f32026-02-27WarningsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINEWalmart Inc.c8fa5ed3-0497-4a23-934b-c72ff02c94ae2026-02-27Warnings, Adverse reactionsExact identifier
application number: M003
FIGS - evolvetogether Hand Sanitizer FIGS 01 Ginger - Cedar ScentedETHYL ALCOHOLWE EVOLVETOGETHER INC.4bd5a36d-06b4-ba41-e063-6294a90aa1212026-02-27WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLUnited Natural Foods, Inc. dba UNFI4eee73dd-039e-44a5-b380-21ff32efee222026-02-26Warnings, Adverse reactionsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1052949benzalkonium chloride 0.12 % Topical SolutionPSN80909a34-21da-4c54-bb62-fd986fd24b042
1052949benzalkonium chloride 1.2 MG/ML Topical SolutionSCD80909a34-21da-4c54-bb62-fd986fd24b042
1052949benzalkonium chloride 0.12 % Topical SolutionSY80909a34-21da-4c54-bb62-fd986fd24b042
1052949benzalkonium chloride 0.12 % Topical SolutionPSN0ccd72e7-16a2-47c7-9ce6-dffb63a0344b1
1052949benzalkonium chloride 1.2 MG/ML Topical SolutionSCD0ccd72e7-16a2-47c7-9ce6-dffb63a0344b1
1052949benzalkonium chloride 0.12 % Topical SolutionSY0ccd72e7-16a2-47c7-9ce6-dffb63a0344b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70094-005-017009400050160 mL in 1 BOTTLE (70094-005-01) 60 ml2024-05-01NoNoCurrent
70094-005-037009400050360 mL in 1 BOTTLE60 mlHistorical