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 23 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Redicare Alcohol Prep PadsMEDIUM ALCOHOL PREP PADSRedicare LLC3cb7fba1-1d2d-f4da-e063-6394a90a4b212026-05-01WarningsExact identifier
application number: M003
SCOTT Antiseptic Foam Skin CleanserCHLOROXYLENOLKimberly-Clarkca761935-7dcc-4caf-b941-60693a97c8a62026-04-30WarningsExact identifier
application number: M003
SCOTT FOAM HAND SANITIZERBENZALKONIUM CHLORIDEKimberly-Clark11234f21-04e4-4b16-88c3-51968a1cedca2026-04-30WarningsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINERetail Business Services, LLCad4e49b6-5784-4880-950b-6e6175fc312b2026-04-30Warnings, Adverse reactionsExact identifier
application number: M003
70%ISOPROPYL ALCOHOLYour Military Exchanges3dcb8422-827d-479b-ba18-eee8dbb762e12026-04-30Warnings, Adverse reactionsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDETarget Corporation33591569-8c56-4721-9d14-d9696f93c7932026-04-30Warnings, Adverse reactionsExact identifier
application number: M003
Oopsie 3 Hydrogen PeroxideHYDROGEN PEROXIDE4 Visions LLC50b0d82a-da2c-5fd0-e063-6294a90aa1652026-04-30WarningsExact identifier
application number: M003
Vita Vie Antibacterial WashBENZALKONIUM CHLORIDESpa De Soleila83883b7-9b63-641b-e053-2995a90ab9432026-04-30WarningsExact identifier
application number: M003
Dr Lift Advanced Antibacterial WipesBENZALKONIUM CHLORIDESpa de Soleilaf89bd25-784e-4828-e053-2995a90a8aaa2026-04-30WarningsExact identifier
application number: M003
Dr Lift Antibacterial Hand WashBENZALKONIUM CHLORIDESpa de Soleilab9e2c3c-d422-255e-e053-2a95a90a7a222026-04-30WarningsExact identifier
application number: M003
Dr Lift Antibacterial Body ScrubBENZALKONIUM CHLORIDESpa de Soleilab9d6c73-29c1-036a-e053-2995a90a449c2026-04-30WarningsExact identifier
application number: M003
KLEENEX Foam Hand SanitizerBENZALKONIUM CHLORIDEKimberly-Clark1fa77ae2-b652-463d-8943-d338c591226e2026-04-29WarningsExact identifier
application number: M003
Ethyl Rubbing AlcoholETHYL ALCOHOLYour Military Exchanges3dce175c-f893-4cfc-b495-6c11f2b77b872026-04-29Warnings, Adverse reactionsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDERetail Business Services, LLC2cc09239-a1d4-4276-adc4-82fdc396e23a2026-04-29Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLPerrigo Direct, Inc11d89d11-103e-4ef6-a996-65cff67f9b322026-04-29Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLWalmart Inc.1fd3d29f-7da0-c5ba-e063-6294a90add162026-04-29Warnings, Adverse reactionsExact identifier
application number: M003
Ethyl AlcoholETHYL ALCOHOLWalmart Inc.1fd3bed0-8fcc-2cee-e063-6294a90a34fb2026-04-29Warnings, Adverse reactionsExact identifier
application number: M003
1438 DynaSoapANTIBACTERIAL HAND SOAPDynarex Corporationab0d5f64-9168-2ea3-e053-2a95a90a321e2026-04-29WarningsExact identifier
application number: M003
SCOTT Antimicrobial Foam Skin CleanserBENZALKONIUM CHLORIDEKimberly-Clark210f7da3-63c5-4a4b-8db0-8d6d1663751d2026-04-28WarningsExact identifier
application number: M003
anzoon ANTISEPTIC WIPESBENZETHONIUM CHLORIDE/BENZALKONIUM CHLORIDEShandong ACZ Biotechnology Co., Ltd.506cd089-f9a7-d9e5-e063-6394a90af6962026-04-27WarningsExact 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