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 51 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Certain Dri Clinical Strength Prescription Protection RollonCERTAIN DRI CLINICAL STRENGTH PRESCRIPTION PROTECTION ROLLONClarion Brands LLC46a1f92e-4411-3989-e063-6394a90a70382025-12-23WarningsExact identifier
application number: M017
PREMIERES PAINMENTHOLPremiere Enterprises128bd1e7-e961-416c-933b-fbd146e3d3862025-12-23WarningsExact identifier
application number: M017
PREMIERES PAINMENTHOLPremiere Enterprises35ff19df-4cc4-4fce-bd30-d87d835e0e262025-12-23WarningsExact identifier
application number: M017
Premieres PainMENTHOLPremiere Enterprises1f081913-6106-4d06-a37a-631f710dbacb2025-12-23WarningsExact identifier
application number: M017
ABSORBINE jr.LIDOCAINE HCL, PHENOLClarion Brands, LLCe1de73bb-917c-48d1-9a78-00c76edddb982025-12-23WarningsExact identifier
application number: M017
ABSORBINE jr. PLUS KneeCAMPHOR, MENTHOLClarion Brands, LLC3ad8718d-ebf1-474f-8a91-48c78ab3b5c12025-12-23WarningsExact identifier
application number: M017
Absorbine Jr. PlusMENTHOLClarion Brands, LLCfd5d77fc-dc73-2aec-2c7f-0fca5d7d3a752025-12-23WarningsExact identifier
application number: M017
ABSORBINE JR PLUS ULTRA STRENGTH PAINMENTHOLClarion Brands, LLCcf329707-d90a-29dd-f2c2-acfd5af614f32025-12-23WarningsExact identifier
application number: M017
Absorbine Jr Pro CreamLIDOCAINE HCL, PHENOLClarion Brands, LLC17b3f1e6-5554-4f3e-b133-76ae8ffea9192025-12-23WarningsExact identifier
application number: M017
Absorbine Jr Pro No Mess Roll-on PlusLIDOCAINE HCL, PHENOLClarion Brands, LLCa7172f17-1525-4738-b72c-92479c730af22025-12-23WarningsExact identifier
application number: M017
ABSORBINE JRMENTHOLClarion Brands, LLCd656e7f6-ca26-1873-6c11-08aa82091bb02025-12-23WarningsExact identifier
application number: M017
Relief RecoveryMETHYL SALICYLATEMayway Corporation27afd45e-2dc5-d099-e063-6394a90ad2b72025-12-23WarningsExact identifier
application number: M017
MobilityMETHYL SALICYLATEMayway Corporation27af9d17-9c15-5e2a-e063-6394a90aeda52025-12-23WarningsExact identifier
application number: M017
medlot pain relief gel patchLIDOCAINELotfancy, Inc.3ce4af20-b227-5b98-e063-6394a90ab9922025-12-23WarningsExact identifier
application number: M017
Nizoral Scalp Itch ReliefHYDROCORTISONEKramer Laboratoriesdba59238-6beb-447e-8c4c-e4bc00fd2c202025-12-23WarningsExact identifier
application number: M017
Salonpas LIDOCAINE Pain RelievingLIDOCAINEHisamitsu America, Inc.63911880-8194-4c7d-a72f-cab94761b2d72025-12-23WarningsExact identifier
application number: M017
The Body Builders CreamMENTHOLSmart Cookie Solutionsf803325e-eb86-4b9e-a401-0a91bdcd63892025-12-22WarningsExact identifier
application number: M017
PROINNATE Numbing CreamLIDOCAINE,MENTHOLGuangdong Aimu Biological Technology Co., Ltd46895ddb-0b9f-675e-e063-6394a90adf232025-12-22WarningsExact identifier
application number: M017
Caring Mills Vaginal Anti-Itch CreamBENZOCAINE, RESORCINOLVeridian Healthcaref2362658-aea2-438e-a66c-738022e6e0472025-12-22WarningsExact identifier
application number: M017
HealthWise Pain Relieving Menthol GelMENTHOL 2%Veridian Healthcare396d0fd4-67be-4de1-8f0c-42c83dfe91202025-12-22WarningsExact 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