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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
05e1f56d-2ee9-d13f-e063-6294a90afc91Available 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
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

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
HAN-I-SIZEHAN-I-SIZEMomar, Inc.05e1f56d-2ee9-d13f-e063-6294a90afc912023-12-11WarningsExact identifier
ndc (product): 63533-693

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