FDA.reportPublic FDA data

ProCure Hand Sanitizer

Product NDC
55681-039
11-digit product format
556810039
Labeler code
55681
Product ID
55681-039_3d8422cf-0f31-e52a-e063-6394a90a957d
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol 70%
Dosage form
GEL
Route
TOPICAL
Labeler
Twin Med LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-09-01
Substance
ALCOHOL
Active strength
70 mL/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ProCure Hand Sanitizer
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL70 mL/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3K9958V90M
Rxcui581662

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
55681-039-04ProCure Hand Sanitizer118 mL in 1 BOTTLE, PLASTICGEL1181
55681-039-10ProCure Hand Sanitizer1000 mL in 1 BAGGEL10001
55681-039-16ProCure Hand Sanitizer473 mL in 1 BOTTLE, PUMPGEL4731
55681-039-80ProCure Hand Sanitizer800 mL in 1 BAGGEL8001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSN3d8422cf-0f30-e52a-e063-6394a90a957d1
581662ethanol 0.7 ML/ML Topical GelSCD3d8422cf-0f30-e52a-e063-6394a90a957d1
581662ethanol 70 % Topical GelSY3d8422cf-0f30-e52a-e063-6394a90a957d1
581662ethyl alcohol 70 % Topical GelSY3d8422cf-0f30-e52a-e063-6394a90a957d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55681-039-0455681003904118 mL in 1 BOTTLE, PLASTIC (55681-039-04) 118 ml2025-09-01NoNoCurrent
55681-039-10556810039101000 mL in 1 BAG (55681-039-10) 1000 ml2025-09-01NoNoCurrent
55681-039-1655681003916473 mL in 1 BOTTLE, PUMP (55681-039-16) 473 ml2025-09-01NoNoCurrent
55681-039-8055681003980800 mL in 1 BAG (55681-039-80) 800 ml2025-09-01NoNoCurrent