FDA.reportPublic FDA data

Hygienic Ear Care Antiseptic

Product NDC
70094-001
11-digit product format
700940001
Labeler code
70094
Product ID
70094-001_098688fd-eb21-29d6-e063-6294a90ade41
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
2020-01-01
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
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
98b70f22-cd53-e61b-e053-2995a90a730dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70094-001-04Hygienic Ear Care Antiseptic118 mL in 1 BOTTLESOLUTION1183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70094-001HYGIENIC EAR CARE ANTISEPTIC (BENZALKONIUM CHLORIDE) SOLUTION [THE RICHLINE GROUP, INC.]3Current NDC, Legacy NDC, 1 package rows20231108_98b70f22-cd53-e61b-e053-2995a90a730d.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 52 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMORA Spray. Hand Sanitizer coconutALCOHOLLongway Technology(Guangzhou) Co., Ltd.44fcf3d3-439b-7869-e063-6294a90a19c32025-12-02WarningsExact identifier
application number: M003
MedPride Instant SanitizerALCOHOLSHIELD LINE LLCa1c87c06-d4d2-cd0f-e053-2995a90a4eaa2025-12-02WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Caramel HoneyALCOHOLShenzhen Lantern Scicence Co.,Ltd.450401c9-2098-9a23-e063-6394a90a20842025-12-02WarningsExact identifier
application number: M003
AMORA Spray. Hand Sanitizer CherryALCOHOLLongway Technology(Guangzhou) Co., Ltd.44e04959-a21e-ba62-e063-6394a90a71922025-12-01WarningsExact identifier
application number: M003
Hand SanitizerETHYL ALCOHOLL&R Distributors, Inc.263457cc-35ff-62fb-e063-6394a90a94da2025-12-01WarningsExact identifier
application number: M003
Hand SanitizerETHYL ALCOHOLL&R Distributors, Inc.2507df2c-9069-01c1-e063-6394a90a85962025-12-01WarningsExact identifier
application number: M003
T.N. Dickinsons Wound CleansingBENZALKONIUM CHLORIDE, PRAMOXINE HYDROCHLORIDEDickinson Brands Inc.c2a8b134-8bb3-4e00-9df4-3229cb372da02025-12-01WarningsExact identifier
application number: M003
safeHands Hand Sanitizer Clean LinenBENZALKONIUM CHLORIDESafehands Distribution Ne, LLC86cc04dc-b66d-4d97-b8da-f5e41f2d13d52025-11-29WarningsExact identifier
application number: M003
safeHands Hand Sanitizer Fragrance FreeBENZALKONIUM CHLORIDESafehands Distribution Ne, LLC0e7af9f7-80a1-4347-89c4-7d9c8b55d65d2025-11-29WarningsExact identifier
application number: M003
Klean FreakBENZALKONIUM CHLORIDEKLEAN FREAK, LLC5376a031-b657-47d4-bf41-c393fdec040b2025-11-28WarningsExact identifier
application number: M003
Klean FreakBENZALKONIUM CHLORIDEKLEAN FREAK, LLC2298e131-3b0c-4104-bf48-5c366d763d452025-11-28WarningsExact identifier
application number: M003
Klean FreakBENZALKONIUM CHLORIDEKLEAN FREAK, LLCbe8b96a2-c4a2-41f8-959b-0fe349cff37e2025-11-28WarningsExact identifier
application number: M003
Klean FreakBENZALKONIUM CHLORIDEKLEAN FREAK, LLCb35cb3d0-1a2d-4ffc-a32e-faa2ca1312ee2025-11-28WarningsExact identifier
application number: M003
Klean FreakBENZALKONIUM CHLORIDEKLEAN FREAK, LLCcef2d3d4-bd5f-4f2a-bb2d-5292b78501c12025-11-28WarningsExact identifier
application number: M003
Klean FreakBENZALKONIUM CHLORIDEKLEAN FREAK, LLC90d6fe21-7b41-4429-8c03-4d35e66a3b292025-11-28WarningsExact identifier
application number: M003
Klean FreakBENZALKONIUM CHLORIDEKLEAN FREAK, LLC87aaabb6-d121-464f-993d-5182de13d49e2025-11-28WarningsExact identifier
application number: M003
FF SILICONE SPRY SANI PPKFF SILICONE SPRY SANI PPKZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD4493c534-187e-f680-e063-6294a90aacdb2025-11-27WarningsExact identifier
application number: M003
Walgreen Maximum strength pain relieving cleansingBENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDEWALGREENS CO.9a0443a2-f1a9-482d-b5ee-abe983e4ae322025-11-26WarningsExact identifier
application number: M003
WalgreensFIRST AID ANTISEPTICWalgreensae731d28-8530-4dd0-aef7-b25f784b47772025-11-26WarningsExact identifier
application number: M003
Hand SanitizerETHYL ALCOHOLHAIAN KANGRUI TEXTILE CO., LTD.44677bab-41ea-3392-e063-6394a90a61872025-11-25WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1052949benzalkonium chloride 0.12 % Topical SolutionPSN98b70f22-cd53-e61b-e053-2995a90a730d3
1052949benzalkonium chloride 1.2 MG/ML Topical SolutionSCD98b70f22-cd53-e61b-e053-2995a90a730d3
1052949benzalkonium chloride 0.12 % Topical SolutionSY98b70f22-cd53-e61b-e053-2995a90a730d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70094-001-0470094000104118 mL in 1 BOTTLE (70094-001-04) 118 ml2020-01-010000-00-00NoNoCurrent