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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3K9958V90MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
581662Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3d8422cf-0f30-e52a-e063-6394a90a957dAvailable on FDA.report

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

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
ProCure Hand SanitizerETHYL ALCOHOL 70%Twin Med LLC3d8422cf-0f30-e52a-e063-6394a90a957d2025-08-29WarningsExact identifier
ndc (product): 55681-039

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