FDA.reportPublic FDA data

Sure Regular Original Solid

Manufacturer
Sodalis USA LLC
Effective date
2024-11-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:35:52

Label at a glance#

ProductSure Regular Original Solid
Active ingredientALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY
Label structure8 sections

Dosage and administration

apply to underarms only.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Aluminum Zirconium trichlorohydrex GLY 16% 

Purpose

OTC - PURPOSE SECTION

Antiperspirant

Use

INDICATIONS & USAGE SECTION

reduces underarm wetness

Warnings

WARNINGS SECTION

For external use only.

Stop use if 

OTC - STOP USE SECTION

rash or irritation occurs.

Do not use 

OTC - DO NOT USE SECTION

on broken skin.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of ingestion, get medical help or contact a Poison Control Center right away.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

kidney disease.

Directions

DOSAGE & ADMINISTRATION SECTION

apply to underarms only.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Cyclopentasiloxane, Stearyl Alcohol, Talc, Dimethicone, Hydrogenated Castor Oil, Fragrance, Dipropylene Glycol, Silica, Polyethylene, Behenyl Alcohol

Questions?

OTC - QUESTIONS SECTION

1-800-575-7960

Label 81277-004-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label4.jpgLabel4.jpg

Label 81277-004-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 76Label 76

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81277-004-01Sure Regular Original Solid48 g in 1 CONTAINERSTICK482
81277-004-02Sure Regular Original Solid76 g in 1 CONTAINERSTICK762

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81277-004SURE REGULAR ORIGINAL SOLID (ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY) STICK [SODALIS USA LLC]2Current NDC, 2 package rows20241109_a6c0a118-0d8c-4d29-b015-cf3ff47f1229.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81277-00481277-004-01, 81277-004-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CYCLOMETHICONE 50THT5PCI0RIACT
STEARYL ALCOHOL2KR89I4H1YIACT
TALC7SEV7J4R1UIACT
DIMETHICONE92RU3N3Y1OIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
DIPROPYLENE GLYCOLE107L85C40IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
DOCOSANOL9G1OE216XYIACT
ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLYT27D6T99LHACTIB

Source Document#

Source XML

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
Sure Regular Original SolidALUMINUM ZIRCONIUM TRICHLOROHYDREX GLYSodalis USA LLCa6c0a118-0d8c-4d29-b015-cf3ff47f12292024-11-08WarningsExact identifier
ndc (package): 81277-004-02
ndc (package): 81277-004-01
ndc (product): 81277-004
ndc11 (package): 81277000402
ndc11 (package): 81277000401
spl id: 266ba600-c124-e90a-e063-6394a90aeaf0
spl set id: a6c0a118-0d8c-4d29-b015-cf3ff47f1229

Reported adverse events (FAERS/openFDA)#

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