FDA.reportPublic FDA data

Sheló NABEL Therapygel Topical Analgesic 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 TherapyGel
Active ingredientMENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC)
Label structure8 sections

Label contents#

Full prescribing information#

Active Ingredient U061

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient U061Active Ingredient U061

Inactive Ingredient U061

INACTIVE INGREDIENT SECTION

Inactive Ingredient U061Inactive Ingredient U061

Warnings U061

WARNINGS SECTION

Warnings U061Warnings U061

Uses U061

OTC - PURPOSE SECTION

Uses U061Uses U061

KROC U061

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KROC U061KROC U061

Admon U061

DOSAGE & ADMINISTRATION SECTION

Admon U061Admon U061

Indications U061

INDICATIONS & USAGE SECTION

Indications U061Indications U061

Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Display PanelDisplay Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1923415camphor 2 % / menthol 2.6 % Topical GelPSN5
1923415camphor 0.02 MG/MG / menthol 0.026 MG/MG Topical GelSCD5
1923415camphor 2 % / menthol 2.6 % Topical GelSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71424-1061-12021-01-29C16284748780-1ba0f9c33-1f1c-a910-e053-dadaa90a0b85Sheló NABEL Therapygel Topical Analgesic Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71424-1061-1Shelo NABEL TherapyGel250 g in 1 BOTTLE, DROPPERGEL2505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71424-1061SHELO NABEL THERAPYGEL (MENTHOL) GEL [CORPORATIVO SERYSI S DE R L DE C V]5Legacy NDC, 1 package rows20191016_503e4db2-99f1-2340-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71424-106171424-1061-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
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
94fa740f-b585-dbff-e053-2995a90a8f3f503e4db2-99f1-2340-e054-00144ff8d46c2019-10-15WarningsExact identifier
spl id: 94fa740f-b585-dbff-e053-2995a90a8f3f
spl set id: 503e4db2-99f1-2340-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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