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 5 of 117 · 2,333 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
hand sanitizer- light pink 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598c41f0-908d-df52-e063-6394a90a3c8d2026-08-21WarningsExact identifier
application number: M003
Olimpo AntibacterialBENZALKONIUM CHLORIDE 0.1%Industria La Popular, S.A.597e3b3e-51f0-5fcf-e063-6394a90ac2972026-08-20WarningsExact identifier
application number: M003
Benzalkonium ChlorideBENZALKONIUM CHLORIDE TOWELETTESTrifecta Pharmaceuticals USA LLC59811e67-57f0-4db1-e063-6294a90a2ad82026-08-20WarningsExact identifier
application number: M003
inControl alcoholISOPROPYL ALCOHOLH-E-B45dfbd7a-0ae1-4146-9527-5483c884e6362026-08-18WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEThe Kroger Co.52f6258f-4b4c-49f4-9bc7-40dc3918869d2026-08-17Warnings, Adverse reactionsExact identifier
application number: M003
70% Isopropyl Rubbing AlcoholISOPROPYL RUBBING ALCOHOLThe Kroger Co.b127bba1-ce0b-4142-8b7d-f12f062b09382026-08-17Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLThe Kroger Co.cd3f8779-9e57-4b23-a029-7424d4d4ab2a2026-08-17Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLThe Kroger Co.ca6c7f8a-d41a-4d77-817c-3dbdc40f890e2026-08-17Warnings, Adverse reactionsExact identifier
application number: M003
Alcohol Sanitizer Spray.ETHYL ALCOHOLGuangdong Yanze Biotechnology Co., Ltd.58fb9efe-43f0-1b7f-e063-6394a90a01452026-08-14WarningsExact identifier
application number: M003
Povidone-IodinePOVIDONE-IODINEMajor Pharmaceuticals59041ca3-a195-5a20-e063-6394a90a2ac92026-08-14WarningsExact identifier
application number: M003
Alcohol Hand SanitizerETHYL ALCOHOLGuangdong Yanze Biotechnology Co., Ltd.58fa90dc-c3b5-787b-e063-6294a90a2e172026-08-13WarningsExact identifier
application number: M003
SprinJeneALCOHOLHealth and Natural Beauty USA Corp1853f023-f4db-4cd8-a4df-a439bc306cc32026-08-13WarningsExact identifier
application number: M003
LUXURY IPA 70%LUXURY ISOPROPYL ALCOHOL 70% 16OZTSM BRANDS LLC2240a9e0-dac5-54fa-e063-6394a90a35f52026-08-11WarningsExact identifier
application number: M003
Ethyl alcoholETHYL ALCOHOLStrategic Sourcing Services LLC4fec6f1f-0249-423f-bd3c-427aa6924c6f2026-08-10Warnings, Adverse reactionsExact identifier
application number: M003
antibacterial hand wipes (JUICY WATERMELON)ANTIBACTERIAL HAND WIPESZhejiang Furuisen Spunlaced Nonwovens Co., Ltd.5883c43d-212b-af39-e063-6394a90ad6522026-08-08WarningsExact identifier
application number: M003
LIGHTS Antiseptic and Pain Relieving Prep PadISOPROPYL ALCOHOLLights Medical Manufacture Co., Ltd.91cc7334-f610-487d-a895-3dda78c3372e2026-08-07WarningsExact identifier
application number: M003
CVS Beauty Hydrating Hand Sanitizer SANDALWOOD MUSKETHYL ALCOHOLCVS Pharmacy, Inc.60128fc3-b127-44ee-9e9b-384d322d213a2026-08-07WarningsExact identifier
application number: M003
CVS Beauty Hydrating Hand Sanitizer Sea Salt and LavenderETHYL ALCOHOLCVS Pharmacy, Inc.6c160826-ad98-4390-a07b-c92a2ae5b1812026-08-07WarningsExact identifier
application number: M003
antibacterial hand wipes (2257C)ANTIBACTERIAL HAND WIPES (2257C)Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd.585a1c36-7bdc-4d4f-e063-6394a90ad6d22026-08-06WarningsExact identifier
application number: M003
antibacterial hand wipes (Angel)ANTIBACTERIAL HAND WIPESZhejiang Furuisen Spunlaced Nonwovens Co., Ltd.585c4a14-8dc9-3a08-e063-6394a90ab4f52026-08-06WarningsExact 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