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 43 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Surgical Scrub Brush/Sponge With Nail CleanerPOVIDONE IODINEXinxiang Xinda Technology Co.,Ltd12585502-c043-6ffb-e063-6394a90a66022026-01-08WarningsExact identifier
application number: M003
Thompson AlcoholISOPROPYL ALCOHOLThompsonf539db3b-f309-6a60-e053-2a95a90a5a9b2026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-MICROBIALUnico International Trading Corpa7d35899-8b70-14f0-e053-2995a90a5ce82026-01-08WarningsExact identifier
application number: M003
Germ AwayANTI-MICROBIAL WIPEUnico International Trading Corpa6b4eec4-0b12-3a00-e053-2a95a90a78352026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-MICROBIALUnico International Trading Corpa7d0ce42-9076-143c-e053-2995a90aeeb62026-01-08WarningsExact identifier
application number: M003
WipexANTIBACTERIAL WIPEUnico International Trading Corporation261c7b8f-4adc-72ec-e063-6394a90a92112026-01-08WarningsExact identifier
application number: M003
WipexANTIBACTERIAL WIPEUnico International Trading Corporation144453a2-8335-77be-e063-6394a90ab6762026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-MICROBIALUnico International Trading Corpa7d40204-3f69-7fb7-e053-2995a90a278b2026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTIBACTERIAL HAND WIPEUnico International Trading Corpad7d8546-d440-e661-e053-2a95a90a8fd32026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-MICROBIALUnico International Trading Corpa7d47c07-12bd-3c8f-e053-2a95a90a95642026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-MICROBIALUnico International Trading Corpa7d7f260-f5be-7940-e053-2995a90aaa032026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTIBACTERIALUnico International Trading Corpada02f20-07ef-9e90-e053-2995a90a0e8b2026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-BACTERIALUnico International Trading Corpadb59182-6541-2b35-e053-2a95a90a0f712026-01-08WarningsExact identifier
application number: M003
Castellani Paint 1.5%PHENOLThe Podiatree Companya10f18e0-b47c-424b-847e-bcc25aa250a42026-01-08WarningsExact identifier
application number: M003
Castellani Paint 1.5%PHENOLThe Podiatree Company5b8cff3c-71d2-418f-a43d-f570aa5408fd2026-01-08WarningsExact identifier
application number: M003
Fortinia IDPHENOLThe Podiatree Company60c88eb7-22fe-4881-e053-2a91aa0a70ce2026-01-08WarningsExact identifier
application number: M003
Gentian Violet 2%GENTIAN VIOLET 2%The Podiatree Company60ba9bb0-cc7a-1ccf-e053-2a91aa0ac4b82026-01-08WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLNDC, Inc.07bfadf4-7452-4c7a-b60e-feb658b92e732026-01-08WarningsExact identifier
application number: M003
Hydrogen Peroxide 3%HYDROGEN PEROXIDE 3%Epic Medical Supply Corp.0da45476-46c3-428c-a2d9-70865d2b12772026-01-08WarningsExact identifier
application number: M003
Roll On Anti Perspirant Alcohol FreeALUMINUM CHLOROHYDRATEMedline Industries, LP4f706801-dc2d-48c4-aa06-92207d86e55e2026-01-08WarningsExact 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