Home NDC 71884-025-01 MY-SHIELD TOPICAL ANTISEPTIC
Product NDC 71884-025
Requested package NDC 71884-025-01
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 Ingredient Strength BENZALKONIUM CHLORIDE 1.3 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F5UM2KM3W7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1098199 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71884-025-01 MY-SHIELD TOPICAL ANTISEPTIC 30 mL in 1 TUBE GEL 30 2 71884-025-04 MY-SHIELD TOPICAL ANTISEPTIC 118 mL in 1 TUBE GEL 118 2 71884-025-06 MY-SHIELD TOPICAL ANTISEPTIC 59 mL in 1 TUBE GEL 59 2 71884-025-08 MY-SHIELD TOPICAL ANTISEPTIC 177 mL in 1 TUBE GEL 177 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71884-025 MY-SHIELD TOPICAL ANTISEPTIC (BENZALKONIUM CHLORIDE) GEL [ENVIRO SPECIALTY CHEMICALS INC] 2 Current NDC, Legacy NDC, 4 package rows 20250106_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 100 of 114 · 2,277 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71884-025-01 71884002501 30 mL in 1 TUBE (71884-025-01) 30 ml 2022-02-24 0000-00-00 No No Current