FDA.reportPublic FDA data

Doloflex Pain Relief

Manufacturer
United Health & Beauty Corp | Maximsuramerica SAS
Effective date
2025-10-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:38:47

Label at a glance#

ProductDoloflex Pain Relief
Active ingredientMENTHOL, METHYL SALICYLATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Menthol 2%, Methyl Salicylate 10%

OTC - PURPOSE SECTION

Topical Analgesic

INDICATIONS & USAGE SECTION

Temporarily relieves the minor aches and pain of muscles and joints associated with simple backache, arthritis, strains, sprains, and bruises.

WARNINGS SECTION

For external use only.

Do not use on children under 12 years of age, with a heating pad (may blister skin), on wounds or damaged skin.

When using this product do not bandage tightly, avoid contact with the eyes or mucous membranes.

Stop use and ask a doctor if excessive irritation develops, symptoms last more than 7 days or clear up and occur again within a few days, condition worsens.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a poison control center right away.

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age or older: apply to affected area up to 3 to 4 times daily. Children under 12 years of age: consult a physician.

INACTIVE INGREDIENT SECTION

Water, alcohol, carbomer, DMDM Hydantoin, Iodopropynyl Butylcarbamate, PEG-40 Hydrogenated Caster Oil, Aesculus Hippocastanum Seed Extract, Centella Assiatica Leaf Extract, Arnica Montana Flowers Oil, Calendula Officinalis Flower Extract, Triethanolamine.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabellabellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2711803menthol 2 % / methyl salicylate 10 % Topical GelPSN2
2711803menthol 0.02 MG/MG / methyl salicylate 0.1 MG/MG Topical GelSCD2
2711803menthol 2 % / methyl salicylate 10 % Topical GelSY2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130731416377294GTIN-13: 0731416377294
EAN-13: 0731416377294
GTIN-12: 731416377294
UPC-A: 731416377294
GTIN storage (14 digits): 00731416377294		Etiqueta DOLOPAIN - Sept 9-2025ai.jpg, Etiqueta DOLOFLEX Farcom - Enero 11-2025ai (2).jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85350-039-10Doloflex Pain Relief300 g in 1 JARGEL3002
85350-039-11Doloflex Pain Relief300 g in 1 JARGEL3002

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85350-03985350-039-10, 85350-039-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
MENTHOLL7T10EIP3AACTIB
PEG-40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
METHYL SALICYLATELAV5U5022YACTIB
DMDM HYDANTOINBYR0546TOWIACT
HORSE CHESTNUT3C18L6RJAZIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
TRIETHANOLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
CENTELLA ASIATICA LEAF6810070TYDIACT
CARBOMER 9404Q93RCW27EIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-03-27full-release2026-06-01 00:59:06

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
Doloflex Pain ReliefMENTHOL, METHYL SALICYLATEUnited Health & Beauty Corp32a830cc-04d3-102e-e063-6294a90a1cad2025-10-12WarningsExact identifier
ndc (package): 85350-039-11
ndc (package): 85350-039-10
ndc (product): 85350-039
ndc11 (package): 85350003911
ndc11 (package): 85350003910
spl id: 40ffa941-e0b5-3f35-e063-6394a90a9d6f
spl set id: 32a830cc-04d3-102e-e063-6294a90a1cad

Reported adverse events (FAERS/openFDA)#

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