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 Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7
Rxcui1038558

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

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