FDA.reportPublic FDA data

Amcon Labs Hand Sanitizer Fragrance Free Gel Sanitizer

Product NDC
51801-437
Requested package NDC
51801-437-08
11-digit product format
518010437
Labeler code
51801
Product ID
51801-437_0a985160-e7c4-ee16-e063-6294a90ae08a
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Nomax, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-08-04
Substance
ALCOHOL
Active strength
600 mL/L
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amcon Labs Hand Sanitizer Fragrance Free Gel Sanitizer
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL600 mL/L

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
581658Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0219f330-81c0-c67f-e063-6394a90a4da9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51801-437-08Amcon Labs Hand Sanitizer Fragrance Free Gel Sanitizer0.237 L in 1 BOTTLE, PUMPGEL0.2372

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51801-437AMCON LABS HAND SANITIZER FRAGRANCE FREE GEL SANITIZER (ALCOHOL) GEL [NOMAX, INC.]2Current NDC, 1 package rows20231121_0219f330-81c0-c67f-e063-6394a90a4da9.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
Amcon Labs Hand Sanitizer Fragrance Free Gel SanitizerALCOHOLNomax, Inc.0219f330-81c0-c67f-e063-6394a90a4da92023-11-20WarningsExact identifier
ndc (package): 51801-437-08
ndc (product): 51801-437
ndc11 (package): 51801043708

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581658ethanol 60 % Topical GelPSN0219f330-81c0-c67f-e063-6394a90a4da92
581658ethanol 0.6 ML/ML Topical GelSCD0219f330-81c0-c67f-e063-6394a90a4da92
581658ethanol 60 % Topical GelSY0219f330-81c0-c67f-e063-6394a90a4da92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51801-437-0851801043708.237 L in 1 BOTTLE, PUMP (51801-437-08) 2023-08-04NoNoCurrent