FDA.reportPublic FDA data

ProCure Antiseptic Wound Cleanser

Product NDC
55681-052
11-digit product format
556810052
Labeler code
55681
Product ID
55681-052_47e63ead-fdcd-15e9-e063-6394a90af8fa
Type
HUMAN OTC DRUG
Nonproprietary name
Benzethonium Chloride 0.13%
Dosage form
SPRAY
Route
TOPICAL
Labeler
Twin Med LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-08
Substance
BENZETHONIUM CHLORIDE
Active strength
.13 g/100mL
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
ProCure Antiseptic Wound Cleanser
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZETHONIUM CHLORIDE.13 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PH41D05744Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
582205Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
47e63ead-fdcc-15e9-e063-6394a90af8faAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55681-052-08ProCure Antiseptic Wound Cleanser236 mL in 1 BOTTLE, SPRAYSPRAY2361

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 78 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Signature Care Advanced Hand Sanitizer With AloeALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.52dccfd7-c288-469e-a067-ee6e5776fd6b2025-05-16WarningsExact identifier
application number: M003
Signature Care Instant Hand Sanitizer WipesALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.49a3c389-33e3-4bd7-a3e7-fe5f4f722bdf2025-05-16WarningsExact identifier
application number: M003
Isopropyl Alcohol WintergreenISOPROPYL ALCOHOLSafeway, Inc.14a22d1e-e498-4661-ab30-6696b8b914d72025-05-16WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLSafeway, Inc.69295fa8-0f0f-495c-a2ef-1414c6fa93a42025-05-16WarningsExact identifier
application number: M003
Smart Care Holiday Hand Sanitizer - Pumpkin SpiceALCOHOLShenzhen Lantern Scicence Co.,Ltd.34ebff92-c075-efdb-e063-6394a90a768f2025-05-12WarningsExact identifier
application number: M003
Smart Care Holiday Hand Sanitizer - CaramelALCOHOLShenzhen Lantern Scicence Co.,Ltd.34ec6817-98e4-2d8c-e063-6394a90ad5df2025-05-12WarningsExact identifier
application number: M003
Meijer Hydrating Power Mist Hand Sanitizer - GingerbreadALCOHOLShenzhen Lantern Scicence Co.,Ltd.34ecbd68-ddab-3e47-e063-6294a90a2e502025-05-12WarningsExact identifier
application number: M003
Novo wipeALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.4ea50d30-b75b-44dc-bda1-d3ac97b34af72025-05-12WarningsExact identifier
application number: M003
Nozin Nasal Sanitizer (Antiseptic)ALCOHOLGlobal Life Technologies Corp.c670ac11-0656-4d85-868e-3a407c9952a32025-05-05WarningsExact identifier
application number: M003
HAND SANITIZER VANILLAALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd36a703b9-bcec-55ab-e063-6294a90af7822025-05-01WarningsExact identifier
application number: M003
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd36a73f9f-faa2-89d5-e063-6294a90a4e0c2025-05-01WarningsExact identifier
application number: M003
The Pharma-C Company 3 Hydrogen Peroxide WipesHYDROGEN PEROXIDEKleen Test Products Corporation7d1c94b1-66bd-4f22-beec-4975efd6b8162025-04-30WarningsExact identifier
application number: M003
POVIDONE-IODINE PREP PADS MEDIUMPOVIDONE-IODINE PREP PADS MEDIUMHF Acquisition Co. LLC, DBA HealthFirst33f08f03-93fb-214d-e063-6394a90a73bd2025-04-29WarningsExact identifier
application number: M003
SANSPRAYANTIBACTERIAL SANITIZER SPRAYBeacon Promotions Inc0e243179-37f6-45dc-e063-6394a90a5f802025-04-28WarningsExact identifier
application number: M003
Sanell Hand SanitizerALCOHOLOraLabs0a6cc2a8-f568-45ae-8d82-a70103c774c72025-04-28WarningsExact identifier
application number: M003
Sanell Hand SanitizerALCOHOLOraLabs7184b9ad-0125-413d-b054-f46239b8ca922025-04-28WarningsExact identifier
application number: M003
Pink Pineapple SCENTED HAND SANITIZERALCOHOLMELON BIO-TECH (THAILAND) CO., LTD.73543eed-e022-4d51-b606-000dcc0232982025-04-28WarningsExact identifier
application number: M003
Vanilla Sugar SCENTED HAND SANITIZERALCOHOLMELON BIO-TECH (THAILAND) CO., LTD.6c790c49-7b4a-4e07-b5ce-9a31db84e01f2025-04-28WarningsExact identifier
application number: M003
Strawberry Pound Cake SCENTED HAND SANITIZERALCOHOLMELON BIO-TECH (THAILAND) CO., LTD.34750790-4eec-4a2d-9686-2c69c1db79e62025-04-28WarningsExact identifier
application number: M003
Sweet Coconut SCENTED HAND SANITIZERALCOHOLMELON BIO-TECH (THAILAND) CO., LTD.f9062bbc-8534-4dcc-920a-19f13d1c0def2025-04-28WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
582205benzethonium chloride 0.13 % Topical SprayPSN47e63ead-fdcc-15e9-e063-6394a90af8fa1
582205benzethonium chloride 1.3 MG/ML Topical SpraySCD47e63ead-fdcc-15e9-e063-6394a90af8fa1
582205benzethonium chloride 0.13 % Topical SpraySY47e63ead-fdcc-15e9-e063-6394a90af8fa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55681-052-0855681005208236 mL in 1 BOTTLE, SPRAY (55681-052-08) 236 ml2026-01-08NoNoCurrent