FDA.reportPublic FDA data

Sipa HAND SANITIZING WIPES

Product NDC
85137-001
11-digit product format
851370001
Labeler code
85137
Product ID
85137-001_46966e2c-fb6f-68b2-e063-6394a90a17e1
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
CLOTH
Route
TOPICAL
Labeler
Sipa Holdings USA, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-10
Substance
BENZALKONIUM CHLORIDE
Active strength
.13 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sipa HAND SANITIZING WIPES
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.13 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
1038558Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2c47f1a8-4416-fd21-e063-6394a90ae167Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85137-001-01Sipa HAND SANITIZING WIPES0.005265 g in 1 PATCHCLOTH0.0052653
85137-001-01Sipa HAND SANITIZING WIPES50 in 1 BAGCLOTH503
85137-001-02Sipa HAND SANITIZING WIPES0.00393 g in 1 PATCHCLOTH0.003933
85137-001-02Sipa HAND SANITIZING WIPES100 in 1 CANISTERCLOTH1003
85137-001-03Sipa HAND SANITIZING WIPES0.00393 g in 1 PATCHCLOTH0.003933
85137-001-03Sipa HAND SANITIZING WIPES250 in 1 CANISTERCLOTH2503
85137-001-04Sipa HAND SANITIZING WIPES500 in 1 CANISTERCLOTH5003
85137-001-04Sipa HAND SANITIZING WIPES0.00393 g in 1 PATCHCLOTH0.003933

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85137-001SIPA HAND SANITIZING WIPES (BENZALKONIUM CHLORIDE) CLOTH [SIPA HOLDINGS USA, INC.]2Current NDC, 8 package rows20250212_2c47f1a8-4416-fd21-e063-6394a90ae167.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sipa HAND SANITIZING WIPESBENZALKONIUM CHLORIDESipa Holdings USA, Inc.2c47f1a8-4416-fd21-e063-6394a90ae1672025-12-23WarningsExact identifier
ndc (product): 85137-001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN2c47f1a8-4416-fd21-e063-6394a90ae1673
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD2c47f1a8-4416-fd21-e063-6394a90ae1673
1038558benzalkonium chloride 0.13 % Topical ClothSY2c47f1a8-4416-fd21-e063-6394a90ae1673
1038558benzalkonium chloride 0.13 % Topical SwabSY2c47f1a8-4416-fd21-e063-6394a90ae1673
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY2c47f1a8-4416-fd21-e063-6394a90ae1673
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY2c47f1a8-4416-fd21-e063-6394a90ae1673
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY2c47f1a8-4416-fd21-e063-6394a90ae1673

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85137-001-018513700010150 PATCH in 1 BAG (85137-001-01) / .005265 g in 1 PATCH50 patch2025-02-10NoNoCurrent
85137-001-0285137000102100 PATCH in 1 CANISTER (85137-001-02) / .00393 g in 1 PATCH100 patch2025-02-10NoNoCurrent
85137-001-0385137000103250 PATCH in 1 CANISTER (85137-001-03) / .00393 g in 1 PATCH250 patch2025-02-10NoNoCurrent
85137-001-0485137000104500 PATCH in 1 CANISTER (85137-001-04) / .00393 g in 1 PATCH500 patch2025-02-10NoNoCurrent