FDA.reportPublic FDA data

Balma Septic Antiseptic Hand Wash

Product NDC
59503-6265
11-digit product format
595036265
Labeler code
59503
Product ID
59503-6265_2b5e378a-fb99-e8b5-e063-6294a90a0baa
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
SOAP
Route
TOPICAL
Labeler
Rochester Midland Corporation
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-05-09
Substance
BENZALKONIUM CHLORIDE
Active strength
25 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct59503-6265UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59503-626559503-6265-6UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59503-626559503-6265-2UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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
Balma Septic Antiseptic Hand Wash
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE25 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
1046529Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1b8e0a27-dcdd-4d07-b0f2-55cf74a9b528Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59503-6265-2Balma Septic Antiseptic Hand Wash3785 mL in 1 BOTTLE, PLASTICSOAP37855
59503-6265-6Balma Septic Antiseptic Hand Wash2500 mL in 1 BOTTLE, PLASTICSOAP25005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59503-6265BALMA SEPTIC ANTISEPTIC HAND WASH (BENZALKONIUM CHLORIDE) SOAP [ROCHESTER MIDLAND CORPORATION]5Current NDC, Legacy NDC, 2 package rows20250112_1b8e0a27-dcdd-4d07-b0f2-55cf74a9b528.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 7 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand-AidALCOHOLABC Compounding Co., Inc.788d7584-bc33-49e8-90fd-767045ea29142025-11-19WarningsExact identifier
application number: M004
VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTICNEOMYCIN SULFATECompania Internacional de Comercio, S.A.P.I de C.V.ba7a3331-466e-496f-bebd-9ee7067bcdb22025-11-19WarningsExact identifier
application number: M004
dabur First AidBACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATEDabur India Limited229170a3-ef9e-597d-e063-6394a90acf8b2025-11-18WarningsExact identifier
application number: M004
QS Plus Instant Hand SanitizerBENZEALKONIUM CHLORIDERomaine Companies5e16f52d-3bf3-4897-bd3a-cf4e117583c92025-11-18WarningsExact identifier
application number: M004
Hand Guard Foaming Instant Hand SanitizerALCOHOLWechem, Inc.d9b89f90-aece-48a2-862a-c524d3c908412025-11-18WarningsExact identifier
application number: M004
Puri-San Plus Instant Hand SanitizerBENZEALKONIUM CHLORIDEPeople's Janitorial Supplyf0726bdd-9d2b-4383-af10-e2e0c5460e1e2025-11-18WarningsExact identifier
application number: M004
Lynx san a foamALCOHOLABC Compounding Co., Inc.2b987ebc-c73b-edbd-e063-6394a90a1d2d2025-11-18WarningsExact identifier
application number: M004
Instant Hand SanitizerALCOHOLABC Compounding Co., Inc.ee46cb57-c79c-4edf-bc88-4a4f8a95bfc82025-11-18WarningsExact identifier
application number: M004
Rapidol Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEPharmadel LLC1ad22205-f8c3-b142-e063-6394a90a00442025-11-17WarningsExact identifier
application number: M004
BacitracinBACITRACINKroger3f860e7f-487b-d706-e063-6394a90a73ad2025-11-13WarningsExact identifier
application number: M004
ElixirBaciShield First AidBACITRACIN ZINCELIXIR HEALTHCARE USA, LLC.15e31a2a-01b5-4598-850f-4d0348086b4b2025-11-12WarningsExact identifier
application number: M004
Bacitracin ZincBACITRACIN ZINCTrifecta Pharmaceuticals USA LLC4352c453-a89c-a2b9-e063-6294a90a61f32025-11-11WarningsExact identifier
application number: M004
Bacitracin ZincBACITRACIN ZINCUniversal Distribution Center LLC186b2750-5bf6-1702-e063-6294a90a62b32025-10-30WarningsExact identifier
application number: M004
POMADA SULFA FIRST AID ANTIBIOTICNEOMYCIN SULFATEGRANDALL DISTRIBUTING, LLC1d8e1fca-6864-7c08-e063-6394a90a08b62025-10-28WarningsExact identifier
application number: M004
POLVO DE SULFA FIRST AID ANTIBIOTICBACITRACIN ZINC, POLYMYXIN B SULFATEGRANDALL DISTRIBUTING, LLC1d8e3a03-a39f-a99e-e063-6394a90a31db2025-10-28WarningsExact identifier
application number: M004
EasyTouch Alcohol Prep Pads SterileISOPROPYL ALCOHOLMHC Medical Products, LLCfd60ad34-5fd9-4440-9f3f-23beffc19dd92025-10-24WarningsExact identifier
application number: M004
Gerigentle-Bacitracin zincBACITRACIN ZINCGeri-Gentle Corporation7e36e4d0-eac3-4aa3-81a7-e21c224b1cd42025-10-23WarningsExact identifier
application number: M004
TripleantibioticointmentandpainreliefBACITRACIN,NEOMYCIN,POLYMXIN, PRAMOXINETrifecta Pharmaceuticals USA54c1d306-dc3b-2885-e054-00144ff8d46c2025-10-22WarningsExact identifier
application number: M004
Zapotol BacitracinBACITRACINZapatol Corp.c8704895-8819-49ac-8baa-5b97be1d00aa2025-10-22WarningsExact identifier
application number: M004
Family Care First AidBACITRACIN ZINCUnited Exchange Corp.df27620e-7312-8082-e053-2995a90aaca62025-10-21WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046529benzalkonium chloride 2.5 % Medicated Liquid SoapPSN1b8e0a27-dcdd-4d07-b0f2-55cf74a9b5285
1046529benzalkonium chloride 25 MG/ML Medicated Liquid SoapSCD1b8e0a27-dcdd-4d07-b0f2-55cf74a9b5285
1046529benzalkonium chloride 2.5 % Medicated Liquid SoapSY1b8e0a27-dcdd-4d07-b0f2-55cf74a9b5285

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59503-6265-2595036265023785 mL in 1 BOTTLE, PLASTIC (59503-6265-2) 3785 ml2017-05-090000-00-00NoNoCurrent
59503-6265-6595036265062500 mL in 1 BOTTLE, PLASTIC (59503-6265-6) 2500 ml2017-05-090000-00-00NoNoCurrent