FDA.reportPublic FDA data

MY-SHIELD TOPICAL ANTISEPTIC

Product NDC
71884-025
11-digit product format
718840025
Labeler code
71884
Product ID
71884-025_3dcede59-1473-403e-9509-96a22f6d9de4
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
GEL
Route
TOPICAL
Labeler
Enviro Specialty Chemicals Inc
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-02-24
Substance
BENZALKONIUM CHLORIDE
Active strength
1.3 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
MY-SHIELD TOPICAL ANTISEPTIC
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1.3 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
1098199Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c2c1f5d9-cd6e-4314-9dfc-961ed877c293Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71884-025-01MY-SHIELD TOPICAL ANTISEPTIC30 mL in 1 TUBEGEL302
71884-025-04MY-SHIELD TOPICAL ANTISEPTIC118 mL in 1 TUBEGEL1182
71884-025-06MY-SHIELD TOPICAL ANTISEPTIC59 mL in 1 TUBEGEL592
71884-025-08MY-SHIELD TOPICAL ANTISEPTIC177 mL in 1 TUBEGEL1772

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71884-025MY-SHIELD TOPICAL ANTISEPTIC (BENZALKONIUM CHLORIDE) GEL [ENVIRO SPECIALTY CHEMICALS INC]2Current NDC, Legacy NDC, 4 package rows20250106_c2c1f5d9-cd6e-4314-9dfc-961ed877c293.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 22 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lucys Renewals Skin and Nails First Aid AntisepticBENZETHONIUM CHLORIDEACP Laboratories LLCa702297d-8f7e-4019-a987-7bd83becb5ee2026-05-07WarningsExact identifier
application number: M003
Scentfull Hand Sanitizer Sea BreezeALCOHOLScent Theory Products LLC3cfac192-84c8-7897-e063-6294a90ae93d2026-05-06WarningsExact identifier
application number: M003
Scentfull Hand Sanitizer Whipped CoconutALCOHOLScent Theory Products LLC3cfaadb3-1881-2dd9-e063-6394a90abcb42026-05-06WarningsExact identifier
application number: M003
Scentfull Hand Sanitizer Pink ChampagneALCOHOLScent Theory Products LLC3cf7a910-28c8-bbe2-e063-6394a90aff732026-05-06WarningsExact identifier
application number: M003
Minee Wipes Antibacterial Hand WipeBENZALKONIUM CHLORIDEAmbition Power Brands5132bc70-bf3b-180c-e063-6394a90afdad2026-05-06WarningsExact identifier
application number: M003
Kleenex Reveal Moisturizing Foam Hand SanitizerALCOHOLKimberly-Clark4a491f90-268e-470d-a74c-473f1efe7c8b2026-05-06WarningsExact identifier
application number: M003
Boo Crew Hand Care Essentials Boo Berry, Pumpkin SpiceALCOHOLScent Theory Products LLC51143d5c-4cd0-0b2e-e063-6294a90a28312026-05-05WarningsExact identifier
application number: M003
Scott Moisturizing Foam Hand SanitizerALCOHOLKimberly-Clark25900e62-c8fd-4942-ad38-4b99243084602026-05-05WarningsExact identifier
application number: M003
EVERLIT CARE PRODUCTS ANTISEPTIC MISTHYDROGEN PEROXIDENantong Health & Beyond Hygienic Products Inc.cb97ba55-d678-4e43-aa85-37e9f530e9112026-05-04WarningsExact identifier
application number: M003
EVERLIT CARE PRODUCTS ANTISEPTIC MISTHYDROGEN PEROXIDEEVERLIT GLOBAL INC.4873b106-4ea2-412c-a7ab-756a111959842026-05-04WarningsExact identifier
application number: M003
Limited Edition Hand Sanitizer Golden Vanilla, Starlight Frost, Pink Satin ProseccoALCOHOLScent Theory Products LLC50f03829-eda8-3a25-e063-6294a90a6fd22026-05-03WarningsExact identifier
application number: M003
DUBBLE BUBBLE HAND SANITIZER BUBBLE GUMALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd52084e0a-ffe2-83f4-e063-6294a90a305e2026-05-01WarningsExact identifier
application number: M003
DIPPIN DOTS HAND SANI BIRTHDAY CAKEALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd520828a5-4e8d-b637-e063-6394a90ab4912026-05-01WarningsExact identifier
application number: M003
ICEE HAND SANI BLUE RASBERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd52089622-d9b5-b5cb-e063-6394a90ad4262026-05-01WarningsExact identifier
application number: M003
DIPPIN DOTS HAND SANITIZER COTTON CANDYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5208adea-27da-81a3-e063-6294a90afc802026-05-01WarningsExact identifier
application number: M003
ICEE HAND SANI CHERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd52089622-d9b6-b5cb-e063-6394a90ad4262026-05-01WarningsExact identifier
application number: M003
KOOL AID HAND SANITIZER BUBBLE PINK LEMONADEALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5208bd2c-277c-648e-e063-6294a90a5b282026-05-01WarningsExact identifier
application number: M003
DIPPIN DOTS HAND SANITIZER RAINBOW ICEALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd52092127-7a8d-5db3-e063-6294a90a07b52026-05-01WarningsExact identifier
application number: M003
Liquid death hand sanitizerALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd520943a4-0e63-a9ab-e063-6394a90ab2a92026-05-01WarningsExact identifier
application number: M003
Redicare Antiseptic TowelettesANTISEPTIC TOWELETTESRedicare LLC484c8ff5-cc11-b646-e063-6394a90a5f502026-05-01WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1098199benzalkonium chloride 0.13 % Topical GelPSNc2c1f5d9-cd6e-4314-9dfc-961ed877c2932
1098199benzalkonium chloride 0.0013 MG/MG Topical GelSCDc2c1f5d9-cd6e-4314-9dfc-961ed877c2932
1098199benzalkonium chloride 0.13 % Topical GelSYc2c1f5d9-cd6e-4314-9dfc-961ed877c2932

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71884-025-017188400250130 mL in 1 TUBE (71884-025-01) 30 ml2022-02-240000-00-00NoNoCurrent
71884-025-0471884002504118 mL in 1 TUBE (71884-025-04) 118 ml2022-02-240000-00-00NoNoCurrent
71884-025-067188400250659 mL in 1 TUBE (71884-025-06) 59 ml2022-02-240000-00-00NoNoCurrent
71884-025-0871884002508177 mL in 1 TUBE (71884-025-08) 177 ml2022-02-240000-00-00NoNoCurrent