FDA.reportPublic FDA data

ProCure Antimicrobial Hand

Product NDC
55681-041
11-digit product format
556810041
Labeler code
55681
Product ID
55681-041_3dfec50e-44e8-9395-e063-6394a90ae44b
Type
HUMAN OTC DRUG
Nonproprietary name
Hand Soap Benzalkonium Chloride (0.13%)
Dosage form
SOAP
Route
TOPICAL
Labeler
Twin Med LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-09-04
Substance
BENZALKONIUM CHLORIDE
Active strength
.13 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ProCure Antimicrobial Hand
Listing expiration
2026-12-31

Active Ingredients#

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

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
1046593Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3dfbe75e-9906-18d7-e063-6294a90ac32eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55681-041-10ProCure Antimicrobial Hand1000 mL in 1 BAGSOAP10002
55681-041-75ProCure Antimicrobial Hand222 mL in 1 BOTTLE, PUMPSOAP2222
55681-041-80ProCure Antimicrobial Hand800 mL in 1 BAGSOAP8002

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ProCure Antimicrobial HandHAND SOAP BENZALKONIUM CHLORIDE (0.13%)Twin Med LLC3dfbe75e-9906-18d7-e063-6294a90ac32e2025-09-04WarningsExact identifier
ndc (product): 55681-041

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN3dfbe75e-9906-18d7-e063-6294a90ac32e2
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD3dfbe75e-9906-18d7-e063-6294a90ac32e2
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY3dfbe75e-9906-18d7-e063-6294a90ac32e2
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY3dfbe75e-9906-18d7-e063-6294a90ac32e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55681-041-10556810041101000 mL in 1 BAG (55681-041-10) 1000 ml2025-09-04NoNoCurrent
55681-041-7555681004175222 mL in 1 BOTTLE, PUMP (55681-041-75) 222 ml2025-09-04NoNoCurrent
55681-041-8055681004180800 mL in 1 BAG (55681-041-80) 800 ml2025-09-04NoNoCurrent