FDA.reportPublic FDA data

HAN-I-SIZE

Product NDC
63533-693
11-digit product format
635330693
Labeler code
63533
Product ID
63533-693_0c415ba1-4681-ce55-e063-6394a90a392c
Type
HUMAN OTC DRUG
Nonproprietary name
HAN-I-SIZE
Dosage form
LIQUID
Route
TOPICAL
Labeler
Momar, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-03-23
Substance
ALCOHOL
Active strength
67 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
HAN-I-SIZE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL67 mL/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3K9958V90M

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
63533-693-01HAN-I-SIZE118 mL in 1 BOTTLE, PLASTICLIQUID1182
63533-693-02HAN-I-SIZE236 mL in 1 BOTTLE, PLASTICLIQUID2362
63533-693-03HAN-I-SIZE3785 mL in 1 BOTTLE, PLASTICLIQUID37852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63533-693HAN-I-SIZE LIQUID [MOMAR, INC.]2Current NDC, 3 package rows20231212_05e1f56d-2ee9-d13f-e063-6294a90afc91.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63533-693-0163533069301118 mL in 1 BOTTLE, PLASTIC (63533-693-01) 118 ml2020-03-23NoNoCurrent
63533-693-0263533069302236 mL in 1 BOTTLE, PLASTIC (63533-693-02) 236 ml2020-03-23NoNoCurrent
63533-693-03635330693033785 mL in 1 BOTTLE, PLASTIC (63533-693-03) 3785 ml2020-03-23NoNoCurrent