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 81 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MedPride Medicated Body Powder PowderMENTHOL, ZINC OXIDEShield Line LLCcdb2fa5b-cf04-c876-e053-2a95a90a187c2025-08-15WarningsExact identifier
application number: M017
BurnLIDOCAINEHART Healthc5ff392a-e788-43e0-91ea-5e0f8420586c2025-08-15WarningsExact identifier
application number: M017
Stopain ClinicalMENTHOLTroy Manufacturing, Inc.40df30ba-41ba-42b7-93fe-4183b57bdb002025-08-14WarningsExact identifier
application number: M017
Signature Care Aloe Vera Gel with LidocaineLIDOCAINESafeway, Inc.d5069622-97b1-ba12-e053-2a95a90a72682025-08-14WarningsExact identifier
application number: M017
METHYL SALICYLATE 25%METHYL SALICYLATEOncora Pharma, LLC3c4bc55d-6582-3b5e-e063-6394a90a994c2025-08-13WarningsExact identifier
application number: M017
Lidocaine 3%LIDOCAINE HCL 3%PureTek Corporation3bc94d52-fe52-9fd6-e063-6294a90a43402025-08-12WarningsExact identifier
application number: M017
Fast FreezeMENTHOLNatural Essentials Inc.d8c42c8d-6ce0-43bf-b165-41979f3d8f792025-08-12WarningsExact identifier
application number: M017
Careland X-large Lidocaine 4 Pain RelievingLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.a6867506-4a46-47b1-b5b6-bfedb59dfde62025-08-11WarningsExact identifier
application number: M017
Dermedial Anti-OuchMENTHOLSaje Natural Business Inc.3c194b8f-cfa5-11e3-e063-6394a90a92de2025-08-11WarningsExact identifier
application number: M017
Thera Plus Extra Strength Muscle Rub Topical AnalgesicMENTHOLFOURSTAR GROUP USA, INC.8a3b6adf-afbb-4d77-a19b-a6514ebd3b502025-08-11WarningsExact identifier
application number: M017
EARTHS CARE ARTHRITISCAPSAICINDLC Laboratories, Inc.9460674b-057e-40b9-a0f9-ca3d92068d4f2025-08-11WarningsExact identifier
application number: M017
LILAS PERIODMENTHOLLilas Wellness, Inc.5ea53b4b-45e6-48a7-8090-09c3a21e7f632025-08-11WarningsExact identifier
application number: M017
Lidocaine Pain Relief Gel Roll-OnLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd31639407-0f11-bde2-e063-6294a90af6942025-08-10WarningsExact identifier
application number: M017
Chinese Red Tiger Lidocaine PatchesLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd20cd369c-3e98-3d8f-e063-6394a90a08242025-08-10WarningsExact identifier
application number: M017
Treatonic LIDOCAINE PAIN RELIEFLIDOCAINE 4%100 KARMA INC3bd66b03-ac82-2d45-e063-6294a90a610a2025-08-08WarningsExact identifier
application number: M017
Capsaicin 0.025%CAPSAICIN 0.025%Advanced Rx of Tennessee, LLC3bdcef94-d06f-9152-e063-6294a90a60722025-08-08WarningsExact identifier
application number: M017
MENTHOL 5%MENTHOL 5%Advanced Rx of Tennessee, LLC3bdd0c52-29d8-ab67-e063-6294a90a9c452025-08-08WarningsExact identifier
application number: M017
Methyl Salicylate 25% CreamMETHYL SALICYLATEAdvanced Rx of Tennessee, LLC3bdd3015-349a-0fac-e063-6394a90afe412025-08-08WarningsExact identifier
application number: M017
LIDOCAINE 4%LIDOCAINE 4%Advanced Rx of Tennessee, LLC3bdd6b3d-7180-288c-e063-6394a90a17852025-08-08WarningsExact identifier
application number: M017
Good Sense Pain Relief Roll OnLIDOCAINE HCLGeiss, Destin & Dunn, Inc38e76fd6-e5fb-493c-e063-6294a90afed42025-08-08WarningsExact 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