FDA.reportPublic FDA data

fomin mini Hand Sanitizer Wipes FRAGRANCE FREE

Product NDC
85755-003
Requested package NDC
85755-003-08
11-digit product format
857550003
Labeler code
85755
Product ID
85755-003_7b60780c-83dd-4264-9390-ad0b533f86d4
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
CLOTH
Route
TOPICAL
Labeler
Fomin LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-20
Substance
BENZALKONIUM CHLORIDE
Active strength
.1 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
fomin mini Hand Sanitizer Wipes FRAGRANCE FREE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.1 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
1038856Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
020f06c6-c76c-40fc-bc56-c11d5b389d67Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85755-003-01fomin mini Hand Sanitizer Wipes FRAGRANCE FREE0.0035 mL in 1 PACKAGECLOTH0.00351
85755-003-01fomin mini Hand Sanitizer Wipes FRAGRANCE FREE8 in 1 PACKETCLOTH81
85755-003-08fomin mini Hand Sanitizer Wipes FRAGRANCE FREE6 in 1 BOXCLOTH61

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
fomin mini Hand Sanitizer Wipes FRAGRANCE FREEBENZALKONIUM CHLORIDEFomin LLC020f06c6-c76c-40fc-bc56-c11d5b389d672025-06-23WarningsExact identifier
ndc (package): 85755-003-08
ndc (product): 85755-003
ndc11 (package): 85755000308

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038856benzalkonium Cl 0.1 % Medicated PadPSN020f06c6-c76c-40fc-bc56-c11d5b389d671
1038856benzalkonium Cl 0.1 % Medicated PadPSN67cd09d6-059b-4769-b573-b6c8b5120d9a1
1038856benzalkonium chloride 1 MG/ML Medicated PadSCD020f06c6-c76c-40fc-bc56-c11d5b389d671
1038856benzalkonium chloride 1 MG/ML Medicated PadSCD67cd09d6-059b-4769-b573-b6c8b5120d9a1
1038856benzalkonium chloride 0.1 % Medicated WipesSY020f06c6-c76c-40fc-bc56-c11d5b389d671
1038856benzalkonium chloride 0.1 % Medicated WipesSY67cd09d6-059b-4769-b573-b6c8b5120d9a1
1038856benzalkonium chloride 0.1 % Topical SwabSY020f06c6-c76c-40fc-bc56-c11d5b389d671
1038856benzalkonium chloride 0.1 % Topical SwabSY67cd09d6-059b-4769-b573-b6c8b5120d9a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85755-003-08857550003086 PACKET in 1 BOX (85755-003-08) / 8 PACKAGE in 1 PACKET (85755-003-01) / .0035 mL in 1 PACKAGE6 packet2025-06-20NoNoCurrent