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 59 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sting and BiteBENZOCAINEPHOENIX HEALTHCARE SOLUTIONS, LLC82791832-1357-48ca-91d4-1328997012612025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLCa225426a-c4d5-459c-bc11-2b521e08e5102025-10-23WarningsExact identifier
application number: M003
Alcohol SwabsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC1516d90b-4879-eb2f-e063-6294a90aa9142025-10-23WarningsExact identifier
application number: M003
Povidone-Iodine Prep Pads MediumPOVIDONE-IODINEMedline Industries, LP28c05c5c-09d3-2c62-e054-00144ff8d46c2025-10-23WarningsExact identifier
application number: M003
Koala Eco Hand SanitizerETHYL ALCOHOLKoala Eco Company USA Ltd41d7d6e3-9961-770d-e063-6394a90a0d242025-10-23WarningsExact identifier
application number: M003
PROHEAL POVIDONE IODINE PREP PADSPOVIDONE-IODINEClick Industries LLC53733b6c-fa62-43e0-bfcc-3d23b5e1a95a2025-10-23WarningsExact identifier
application number: M003
POVIDONE-IODINEPOVIDONE-IODINEJames Alexander Corporation181a6363-2249-45f0-a28b-79f2c5ffad592025-10-23WarningsExact identifier
application number: M003
American Red Cross AntisepticBENZALKONIUM CHLORIDE 0.13%(W/W)/BENZOCAINE 5.00%(W/W)Zhejiang Guoyao Jingyue Aerosol Co., Ltd.41bbf123-9ff9-5e8a-e063-6394a90af15f2025-10-22WarningsExact identifier
application number: M003
CA-REZZ NORISC ANTIBACTERIAL SKIN CAREBENZETHONIUM CHLORIDEFNC MEDICAL CORPORATIONf93c55f9-b3e1-45f6-8e0d-09e60f5b822f2025-10-22WarningsExact identifier
application number: M003
CA-REZZ - NORISC - INCONTINENT WASHBENZETHONIUM CHLORIDEFNC MEDICAL CORPORATIONed26fa74-5ae8-4294-b61d-682d6ad4b32a2025-10-22WarningsExact identifier
application number: M003
CA-REZZ - LONG TERM CARE - INCONTINENT CLEANSERBENZETHONIUM CHLORIDEFNC MEDICAL CORPORATIONd06b0489-86d3-4bf1-928f-fc524a71560e2025-10-22WarningsExact identifier
application number: M003
Northside Hospital Maternity Backpack-BASEALCOHOL AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLc86458169-92eb-45a5-b3cc-6eccd8caa1e82025-10-22WarningsExact identifier
application number: M003
Northside Hospital Maternity Backpack BASESODIUM MONOFLUOROPHOSPATEALLIANCE FORMULATIONS5d0e768f-086c-4b8c-b618-6dde70f302f92025-10-22WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sea BreezeETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.41a5db85-05b8-ecd6-e063-6394a90ac3872025-10-21WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer StrawBerry ShortCakeETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.41a62d9f-4d46-f8ca-e063-6294a90ae1ed2025-10-21WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Vanilla CloudETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.41a69d10-f7bf-cf17-e063-6294a90a177d2025-10-21WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Watermelon AloeETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.41a7735f-03b7-4fdc-e063-6394a90a100b2025-10-21WarningsExact identifier
application number: M003
American Red Cross 70% Isopropyl AlcoholISOPROPYL ALCOHOL(70%CONC.)Zhejiang Guoyao Jingyue Aerosol Co., Ltd.41b6ee3f-55f4-0502-e063-6394a90aa3572025-10-21WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Tangy TerraneALCOHOLShenzhen Lantern Scicence Co.,Ltd.4192dbc6-5d9a-d42a-e063-6394a90aa2d82025-10-20WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Sweet and StillALCOHOLShenzhen Lantern Scicence Co.,Ltd.41934870-d87e-1c51-e063-6294a90abd2d2025-10-20WarningsExact 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