FDA.reportPublic FDA data

Puri-San Plus Instant Hand Sanitizer

Product NDC
43097-457
11-digit product format
430970457
Labeler code
43097
Product ID
43097-457_43e1140a-8208-9189-e063-6394a90a367f
Type
HUMAN OTC DRUG
Nonproprietary name
BENZEALKONIUM CHLORIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
People's Janitorial Supply
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-02-20
Substance
BENZALKONIUM CHLORIDE
Active strength
1.3 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage43097-45743097-457-10DDiscontinued by firm2026-10-12
excluded packagepackage43097-45743097-457-14DDiscontinued by firm2026-10-12
excluded packagepackage43097-45743097-457-18DDiscontinued by firm2026-10-12

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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43097-457-18DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43097-457-14DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43097-457-10DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43097-457-14UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43097-457-18UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43097-457-12UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43097-457-10UExcluded because listing certification expired0efc9e666f02…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
Puri-San Plus Instant Hand Sanitizer
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1.3 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
1049254Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f0726bdd-9d2b-4383-af10-e2e0c5460e1eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43097-457-10Puri-San Plus Instant Hand Sanitizer1000 mL in 1 CARTRIDGELIQUID10004
43097-457-12Puri-San Plus Instant Hand Sanitizer1000 mL in 1 BAGLIQUID10004
43097-457-14Puri-San Plus Instant Hand Sanitizer3785 mL in 1 BOTTLE, PLASTICLIQUID37854
43097-457-18Puri-San Plus Instant Hand Sanitizer50 mL in 1 BOTTLE, PLASTICLIQUID504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43097-457PURI-SAN PLUS INSTANT HAND SANITIZER (BENZEALKONIUM CHLORIDE) LIQUID [PEOPLE'S JANITORIAL SUPPLY]3Current NDC, Legacy NDC, 4 package rows20250112_f0726bdd-9d2b-4383-af10-e2e0c5460e1e.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 4 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lynx LX0864 peachy-foam antiseptic handsoapCHLOROXYLENOLABC Compounding Co., Inc.dd8025cb-d160-83a4-e053-2a95a90a51ac2026-05-11WarningsExact identifier
application number: M004
Satin Foam High Foaming Antiseptic Hand WashCHLOROXYLENOLCertus Medical, Inc.ea49da65-ae5e-bfde-e053-2a95a90adef22026-05-11WarningsExact identifier
application number: M004
Freshands Premium Foamy Antibacterial Handsoap 6876CHLOROXYLENOLConsolidated Chemicals, LLCf17299a4-28d6-e65b-e053-2a95a90a05e72026-05-11WarningsExact identifier
application number: M004
Harris Teeter Triple Antibiotic and Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, BACITRACIN ZINC, PRAMOXINE HCLHARRIS TEETER LLC4b0c0a3c-7145-97ca-e063-6394a90a1a962026-05-07WarningsExact identifier
application number: M004
Harris Teeter Triple AntibioticNEOMYCIN SULFATE, POLYMYXIN B SULFATE, BACITRACIN ZINCHARRIS TEETER LLC4e81590c-32d3-f8aa-e063-6294a90ab3412026-05-06WarningsExact identifier
application number: M004
FIRSTAR TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.5b9434ad-83d7-4df3-bfef-3db152e6c6cc2026-05-04WarningsExact identifier
application number: M004
oopsie First AidBACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE4 Visions LLC50b21f0a-1e87-51ae-e063-6294a90a8a3c2026-04-30WarningsExact identifier
application number: M004
First Aid Kit, Lil Drug Store5 ADHESIVE BANDAGES, 2 ANTIBIOTIC OINTMENTSLil' Drug Store Products, Inc.503c6c0e-3e1a-71ed-e063-6394a90abfa22026-04-24WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.TRIFECTA PHARMACEUTICALS USA LLC23a35ba8-ebc6-4252-bb88-ec237425056c2026-04-15WarningsExact identifier
application number: M004
El Valle Gentian VioletGENTIAN VIOLET 1%Pharmadel LLCfc75aa2b-0e6e-e2f7-e053-6294a90ac01f2026-04-13WarningsExact identifier
application number: M004
Bacitracin ZincBACITRACIN ZINCSun Pharmaceutical Industries, Inc.4afdeedf-9cdf-47d6-919f-ea907fda02902026-04-10WarningsExact identifier
application number: M004
Family Care Triple Antibiotic Original Formula 0.33ozTRIPLE ANTIBIOTIC ORIGINAL FORMULAUnited Exchange Corp4f1ef127-a67e-ca60-e063-6394a90a3a3d2026-04-10WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HYDROCHLORIDEH E B2a143950-13b4-457e-91a4-c61a88aad84b2026-04-02WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.ProStat First Aid, LLC.4e54f479-ad87-e86b-e063-6394a90aa6d22026-03-31WarningsExact identifier
application number: M004
El Valle MerthiolateBENZALKONIUM CHLORIDEPharmadel LLCfd7b28ca-9f71-0ff6-e053-6394a90a48222026-03-26WarningsExact identifier
application number: M004
sojo Triple AntibioticTRIPLE ANTIBIOTICJiangxi Yudexi Pharmaceutical Co., LTD4d8429bd-24b9-ad3c-e063-6294a90aeba02026-03-21WarningsExact identifier
application number: M004
Neosporin Plus Pain Relief ClubtrayBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLCf4545718-8643-a340-e053-2995a90a00792026-03-18WarningsExact identifier
application number: M004
BacitracinBACITRACINPreferred Pharmaceuticals Inc.2f115e22-10f5-47fe-85df-f59e4387a3732026-03-16WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.ProStat First Aid, LLC.4cd49c65-e347-7589-e063-6394a90a53bd2026-03-12WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.ProStat First Aid, LLC.4cc6d822-f383-2ceb-e063-6294a90aecc72026-03-11WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049254benzalkonium chloride 0.13 % Topical SolutionPSNf0726bdd-9d2b-4383-af10-e2e0c5460e1e4
1049254benzalkonium chloride 1.3 MG/ML Topical SolutionSCDf0726bdd-9d2b-4383-af10-e2e0c5460e1e4
1049254benzalkonium chloride 0.13 % Topical SolutionSYf0726bdd-9d2b-4383-af10-e2e0c5460e1e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43097-457-10430970457101000 mL in 1 CARTRIDGE (43097-457-10) 1000 ml2019-02-200000-00-00NoNoCurrent
43097-457-12430970457121000 mL in 1 BAG (43097-457-12) 1000 ml2019-02-200000-00-00NoNoCurrent
43097-457-14430970457143785 mL in 1 BOTTLE, PLASTIC (43097-457-14) 3785 ml2019-02-200000-00-00NoNoCurrent
43097-457-184309704571850 mL in 1 BOTTLE, PLASTIC (43097-457-18) 50 ml2019-02-200000-00-00NoNoCurrent