Doloflex Pain Relief

Product NDC
85350-039
11-digit product format
853500039
Labeler code
85350
Product ID
85350-039_40ffa941-e0b5-3f35-e063-6394a90a9d6f
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol, Methyl Salicylate
Dosage form
GEL
Route
TOPICAL
Labeler
United Health & Beauty Corp
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-17
Substance
MENTHOL; METHYL SALICYLATE
Active strength
2; 10 g/100g; g/100g
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
Doloflex Pain Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL2 g/100g
METHYL SALICYLATE10 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
LAV5U5022YInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2711803Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
32a830cc-04d3-102e-e063-6294a90a1cadAvailable on FDA.report

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85350-039DOLOFLEX PAIN RELIEF (MENTHOL, METHYL SALICYLATE) GEL [UNITED HEALTH & BEAUTY CORP]1Current NDC, 2 package rows20250416_32a830cc-04d3-102e-e063-6294a90a1cad.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 68 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HCl and Zinc AcetateEXTRA STRENGTH ITCH RELIEF CONTINUOUS SPRAYTopco Associates LLC8026c7dd-eb7b-ebea-e053-2991aa0a1b0f2025-11-06WarningsExact identifier
application number: M017
Diphenhydramine HCl and Zinc AcetateEXTRA STRENGTH ITCH RELIEFWalgreen Company6057b4ff-6adc-4688-893c-62d237d7d1ae2025-11-06WarningsExact identifier
application number: M017
BANPINGHUA Glucosamine Chondroitin PatchPEPPERMINT, CAMPHOR, BORNEOLHenan Lijitang Medical Technology Co., Ltd.42f8c2ae-50a2-2358-e063-6394a90a59792025-11-06WarningsExact identifier
application number: M017
PAINGELCAMPHOR, MENTHOLNACOR BUSINESS GROUP LLC42fa2397-b61a-3b16-e063-6294a90a5fed2025-11-06WarningsExact identifier
application number: M017
PAINGEL UNGUENTOCAMPHOR, MENTHOLNACOR BUSINESS GROUP LLC42fab525-b0a5-97fb-e063-6394a90aec6c2025-11-06WarningsExact identifier
application number: M017
PAINGEL ROLL-ONMENTHOLNACOR BUSINESS GROUP LLC42fb0bdf-8bbd-bbe3-e063-6294a90a656c2025-11-06WarningsExact identifier
application number: M017
CoolexaCAMPHOR, MENTHOL, METHYL SALICYLATERising Pharma Holdings, Inc.38839f29-d4ce-4684-a3c7-0bb4bf1ad5942025-11-06WarningsExact identifier
application number: M017
ItchZapDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATERising Pharma Holdings, Inc.245d0afb-19a8-4cfb-968b-d892b18d5f2c2025-11-06WarningsExact identifier
application number: M017
Pain Relief Gel-Roll OnLIDOCAINE AND MENTHOLBullet point LLC42c70681-494b-47c9-e063-6394a90a80be2025-11-04WarningsExact identifier
application number: M017
China-Gel Topical Pain RelieverMENTHOL AND CAMOHOR (SYNTHETIC)China-Gel, LLCba6c7e97-d740-484b-8711-55fa7ab157842025-11-04WarningsExact identifier
application number: M017
China-GelMENTHOL AND CAMOHOR (SYNTHETIC)China-Gel, Inc.d7c5cb17-f7a2-7f57-e053-2995a90a40f72025-11-04WarningsExact identifier
application number: M017
Aulief Topical Pain RelieverMENTHOL AND CAMOHORChina-Gel, LLC8647dcc3-1dbc-1093-e053-2991aa0a1ab92025-11-04WarningsExact identifier
application number: M017
China-Gel Topical Pain RelieverMENTHOL AND CAMOHOR (SYNTHETIC)China-Gel, LLC254abae9-ef1b-5a90-e054-00144ff88e882025-11-04WarningsExact identifier
application number: M017
Pain Relief Gel-TubeMENTHOLBullet point LLC42c93789-9758-54b7-e063-6394a90ac3982025-11-04WarningsExact identifier
application number: M017
Tattoo careTATTOO CARE CREAMPerfso (HK) Co., Limited42d0f56f-9cb1-8e19-e063-6394a90aa3e02025-11-04WarningsExact identifier
application number: M017
CORE RELIEFCAMPHOR, MENTHOLCopper Joint, LLC42d17270-f58d-9d69-e063-6294a90a40782025-11-04WarningsExact identifier
application number: M017
Lidocaine and MentholLIDOCAINE AND MENTHOLMarcella Healthd25f25ee-79f8-49e7-9715-0aae305b73e52025-11-03WarningsExact identifier
application number: M017
Calamine Plus Pramoxine HClCALAMINE PLUS NO TOUCH SPRAYPremier Brands of America Inc.36481d67-2346-470b-e063-6294a90aae992025-11-03WarningsExact identifier
application number: M017
Lidocaine Numbing CreamLIDOCAINE 5%YYBA Corp1319ee69-8b3f-5815-e063-6294a90a5ad52025-11-03WarningsExact identifier
application number: M017
Goodsense Extra Strength Cold and Hot MedicatedMENTHOLGeiss, Destin and Dunn, Inc.7585d111-775f-4fb6-a485-28cd99d888522025-10-31WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2711803menthol 2 % / methyl salicylate 10 % Topical GelPSN32a830cc-04d3-102e-e063-6294a90a1cad2
2711803menthol 0.02 MG/MG / methyl salicylate 0.1 MG/MG Topical GelSCD32a830cc-04d3-102e-e063-6294a90a1cad2
2711803menthol 2 % / methyl salicylate 10 % Topical GelSY32a830cc-04d3-102e-e063-6294a90a1cad2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85350-039-1085350003910300 g in 1 JAR (85350-039-10) 300 g2025-03-17NoNoCurrent
85350-039-1185350003911300 g in 1 JAR (85350-039-11) 300 g2025-09-30NoNoCurrent