FDA.reportPublic FDA data

Shelo NABEL Arnica Gel

Manufacturer
Corporativo Serysi S de R L de C V
Effective date
2019-10-15
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:00:50

Label at a glance#

ProductShelo NABEL Arnica Gel
Active ingredientMENTHOL
Label structure8 sections

Label contents#

Full prescribing information#

Active Ingredient U058

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient U058Active Ingredient U058

Inactive Ingredient U058

INACTIVE INGREDIENT SECTION

Inactive Ingredient U058Inactive Ingredient U058

Warnings U058

WARNINGS SECTION

Warnings U058Warnings U058

KROC U058

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KROC U058KROC U058

Administration U058

DOSAGE & ADMINISTRATION SECTION

Administration U058Administration U058

Indications U058

INDICATIONS & USAGE SECTION

IndicationsIndications

Uses U058

OTC - PURPOSE SECTION

Uses U058Uses U058

Display Panel U058

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Display PanelDisplay Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
866128menthol 1.25 % Topical GelPSN5
866128menthol 0.0125 MG/MG Topical GelSCD5
866128menthol 1.25 % Topical GelSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71424-1058-12021-01-29C16284748780-1ba0f9c33-1488-a910-e053-dadaa90a0b85Sheló NABEL Árnica Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71424-1058-1Shelo NABEL Arnica Gel250 g in 1 BOTTLE, DISPENSINGGEL2505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71424-1058SHELO NABEL ARNICA GEL (MENTHOL) GEL [CORPORATIVO SERYSI S DE R L DE C V]5Legacy NDC, 1 package rows20191016_5021d905-2a37-1fea-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71424-105871424-1058-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
POLYSORBATE 207T1F30V5YHIACT

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
94faa15b-053f-24fb-e053-2a95a90aa2225021d905-2a37-1fea-e054-00144ff8d46c2019-10-15WarningsExact identifier
spl id: 94faa15b-053f-24fb-e053-2a95a90aa222
spl set id: 5021d905-2a37-1fea-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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