FDA.reportPublic FDA data

Escudo Ultra-Protect Soft Care

Product NDC
84529-002
11-digit product format
845290002
Labeler code
84529
Product ID
84529-002_49f146b4-8be0-2df2-e063-6294a90a95f6
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
SOAP
Route
TOPICAL
Labeler
Indelpa, Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-08
Substance
BENZALKONIUM CHLORIDE
Active strength
.1 g/100g
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
Escudo Ultra-Protect Soft Care
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.1 g/100g

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
1926450Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1cc4b68b-dceb-3fab-e063-6294a90ab112Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
07cba15c-4adc-1039-9ab9-45f5b7e84f4fProduct name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84529-002-01Escudo Ultra-Protect Soft Care115 g in 1 CELLO PACKSOAP1153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84529-002ESCUDO ULTRA-PROTECT SOFT CARE (BENZALKONIUM CHLORIDE) SOAP [INDELPA, INC.]1Current NDC, 1 package rows20240711_1cc4b68b-dceb-3fab-e063-6294a90ab112.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 42 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLDiscount Drug Mart37a6c0fb-e9c4-4a95-9539-ca5766b3a7012026-01-12WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLDiscount Drug Mart7ac6b062-b471-4653-9d6f-de2ca8f8b0142026-01-12WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEDiscount Drug Mart7663654d-3697-40aa-8357-0978be7773a42026-01-12WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLEpic Medical Supply Corp.88e6418c-ceb3-4bd6-8765-b476d8bf3ff32026-01-12WarningsExact identifier
application number: M003
WISH HYDROGEN PEROXIDEWISH HYDROGEN PEROXIDE 3%CLICK PRODUCTS LLC48370aaa-da08-a2ef-e063-6394a90a62b32026-01-12WarningsExact identifier
application number: M003
SANMO-BLMOISTURIZING SANITIZER WITH BLUE BEADSBeacon Promotions, Inc.1eb96fb8-d750-9241-e063-6394a90a1cdd2026-01-12WarningsExact identifier
application number: M003
Unscented SanitizerUNSCENTED SANITIZERBeacon Promotions, Inc.1f96aecf-8ca2-aa27-e063-6394a90abb792026-01-12WarningsExact identifier
application number: M003
Scented Hand SanitizerSCENTED HAND SANITIZERBeacon Promotions, Inc.1f95444c-7587-a07e-e063-6394a90af5342026-01-12WarningsExact identifier
application number: M003
Povidone Iodine Prep PadPOVIDONE-IODINENINGBO TIANBO FIRST AID PRODUCT CO., LTD.6d472aef-0d95-4c21-a373-bd16bc7b63ed2026-01-12WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLNINGBO TIANBO FIRST AID PRODUCT CO., LTD.3cce065a-0254-43ad-a96f-aae6979997be2026-01-12WarningsExact identifier
application number: M003
Quality Choice Isopropyl Alcohol WipesISOPROPYL ALCOHOLChain Drug Marketing Association, Inc.b58145c6-0f6c-5a47-e053-2995a90a5d7f2026-01-09WarningsExact identifier
application number: M003
Quality Choice Hydrogen Peroxide WipesHYDROGEN PEROXIDEChain Drug Marketing Association, Inc.b5815ca2-edaa-bc8c-e053-2a95a90a3df22026-01-09WarningsExact identifier
application number: M003
ISOPROPYL RUBBING ALCOHOL 50 PERCENTISOPROPYL ALCOHOLJC SALES1f3466d2-6a2e-f871-e063-6394a90af0852026-01-09WarningsExact identifier
application number: M003
NOxyDERMBENZALKONIUM CHLORIDENOxy Health Products1e2cb45c-7e70-01dd-e063-6294a90aa16b2026-01-09WarningsExact identifier
application number: M003
NOxyDERMBENZALKONIUM CHLORIDENOxy Health Products063a1e99-dda6-9cb9-e063-6294a90aa1b32026-01-09WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLEpic Medical Supply Corp.04ac8597-00fa-458f-a929-ada5042a8c382026-01-09WarningsExact identifier
application number: M003
Instant Hand Sanitizeing WipeALCOHOLSHANDONG HENGFA HYGIENIC PRODUCTS CO., LTD.bd17c0c7-d824-6b03-e053-2995a90afe152026-01-08WarningsExact identifier
application number: M003
Surgical Scrub Brush/Sponge With Nail Cleaner 3.3% PCMXCHLOROXYLENOLXinxiang Xinda Technology Co.,Ltd125b3c3b-0a3a-9fd3-e063-6394a90a135a2026-01-08WarningsExact identifier
application number: M003
Surgical Scrub Brush/Sponge With Nail CleanerPOVIDONE IODINEXinxiang Xinda Technology Co.,Ltd125a49c3-15c0-fbad-e063-6394a90a5d2e2026-01-08WarningsExact identifier
application number: M003
Surgical Scrub Brush/Sponge With Nail Cleaner 4% CHGCHLORHEXIDINE GLUCONATEXinxiang Xinda Technology Co.,Ltd125ac9df-03db-83e9-e063-6394a90afeab2026-01-08WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1926450benzalkonium chloride 0.1 % Medicated Bar SoapPSN1cc4b68b-dceb-3fab-e063-6294a90ab1123
1926450benzalkonium chloride 0.001 MG/MG Medicated Bar SoapSCD1cc4b68b-dceb-3fab-e063-6294a90ab1123
1926450benzalkonium chloride 0.1 % Medicated Bar SoapSY1cc4b68b-dceb-3fab-e063-6294a90ab1123

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84529-002-0184529000201115 g in 1 CELLO PACK (84529-002-01) 115 g2024-07-09NoNoCurrent