FDA.reportPublic FDA data

Pain Relief Gel Roll On

Product NDC
69396-184
11-digit product format
693960184
Labeler code
69396
Product ID
69396-184_50b1a42e-f7ee-74db-e063-6294a90a7d89
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
GEL
Route
TOPICAL
Labeler
Trifecta Pharmaceuticals USA
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-04-27
Substance
MENTHOL
Active strength
40 g/L
NDC exclude flag
No
Listing certified through
2027-12-31
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
Pain Relief Gel Roll On
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL40 g/L

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
415974Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
50b1a420-d5cd-6d61-e063-6294a90a0451Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-184-01Pain Relief Gel Roll On1 in 1 BOXGEL11
69396-184-01Pain Relief Gel Roll On0.074 L in 1 BOTTLEGEL0.0741
69396-184-03Pain Relief Gel Roll On0.074 L in 1 BOTTLEGEL0.0741
69396-184-03Pain Relief Gel Roll On3 in 1 BOXGEL31

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 11 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OWELL NATURALS NEUROPATHY MAXIMUM STRENGTHMENTHOLOWELL NATURAL 8 LLC56b8d0cc-2f35-7d38-e063-6294a90ad06d2026-07-16WarningsExact identifier
application number: M017
ANTIPHLAMINEL-MENTHOL, L-CAMPHOR, METHYL SALICYLATEMasaem Company56b93c89-295b-f33a-e063-6294a90a5fe42026-07-16WarningsExact identifier
application number: M017
Meriwether Skin Pain ReliefMENTHOL, UNSPECIFIED FORMMeriwether Skin LLCf6e155be-5879-4176-bb0e-e364f2e5cdf92026-07-16WarningsExact identifier
application number: M017
Medi-First Muscle Rub CreamMENTHOL, METHYL SALICYLATEUnifirst First Aid Corporation56a6b8b2-7ab0-9854-e063-6294a90ab5ba2026-07-15WarningsExact identifier
application number: M017
Painsil Pain Relief Roll-OnLIDOCAINE HYDROCHLORIDEPainsil LLCdee39dff-5749-4ef2-a9ed-182f25e01f672026-07-14WarningsExact identifier
application number: M017
VARICOSE VEINS MAXIMUM STRENGTHMENTHOLOWELL NATURAL & LLC5692914f-1b14-e3e3-e063-6394a90a94bf2026-07-14WarningsExact identifier
application number: M017
ZyloReliefLIDOCAINE HYDROCHLORIDEHighmark Pharma LLC635f5b98-f74c-495f-a537-686fcba9ccad2026-07-14WarningsExact identifier
application number: M017
ENOKON PAIN RELIEF Spray.PAIN RELIEF SPRAY.Henan Enokon Medical Instrument Co., Ltd.5675ec21-b947-2206-e063-6294a90aa5092026-07-12WarningsExact identifier
application number: M017
Topcare Pain Relief PatchPAIN RELIEF PATCH MEDICATED 5% MENTHOL761624f00d0b8-d2f4-843b-e063-6294a90a332b2026-07-12WarningsExact identifier
application number: M017
Penetral Roll-onCAPSAICIN 0.025%PureTek Corporation56204c03-8b15-a8b5-e063-6394a90a81892026-07-10WarningsExact identifier
application number: M017
Intensive Healing Itch ReliefITCH RELIEF CREAMNeilMed Pharmaceuticals Inc563ef1d5-2180-bc45-e063-6294a90a813d2026-07-10WarningsExact identifier
application number: M017
AVON Foot Works Arthritis Achy Foot and MuscleMETHYL SALICYLATECOSMAX USA, CORPORATION56440d3f-bc93-cebb-e063-6294a90a5f792026-07-10WarningsExact identifier
application number: M017
CHEONG KUN PAIN RELIEVINGCAMPHORCHEONG KUN PAIN RELIEVER OIL CHINESE MEDICINE FACTORY (MACAU) LIMITED557d5cb3-2a05-4f45-e063-6394a90a9b122026-07-10WarningsExact identifier
application number: M017
Biofreeze ProfessionalMENTHOLReckitt Benckiser LLC485c8208-c93b-5b84-e063-6394a90ab77a2026-07-10WarningsExact identifier
application number: M017
Fit Mist Pain ReliefMENTHOLAroma Sensations Incf5a98544-8bd7-42dc-a594-5559e3920e292026-07-09WarningsExact identifier
application number: M017
Nuturna SciaticaMENTHOLMicelle Laboratories, Incorporatedff200864-bedf-4138-bdec-2b23701406dd2026-07-09WarningsExact identifier
application number: M017
Lidocaine creamDRS LIDOCAINE 5% CREAMOL PHARMA TECH LLC. (Drs. Pharmacy)372fe018-1e5a-9ec4-e063-6294a90a15002026-07-09WarningsExact identifier
application number: M017
Nupharmisto 4% Lidocaine Numbing creamLIDOCAINE 4%EveryMarket Inc5615e49d-e03b-f915-e063-6294a90a17862026-07-08WarningsExact identifier
application number: M017
CAREALL Musle and JointMENTHOLNew World Imports, Inc561cc103-ae88-8f30-e063-6294a90a05c42026-07-08WarningsExact identifier
application number: M017
HealthWise Medicated Cold HotMENTHOLVeridian Healthcare, LLC561e1409-d1d8-e35d-e063-6394a90a4d8f2026-07-08WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
415974menthol 4 % Topical GelPSN50b1a420-d5cd-6d61-e063-6294a90a04511
415974menthol 0.04 MG/MG Topical GelSCD50b1a420-d5cd-6d61-e063-6294a90a04511
415974menthol 4 % Topical GelSY50b1a420-d5cd-6d61-e063-6294a90a04511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69396-184-01693960184011 BOTTLE in 1 BOX (69396-184-01) / .074 L in 1 BOTTLE1 bottle2026-04-30NoNoCurrent
69396-184-03693960184033 BOTTLE in 1 BOX (69396-184-03) / .074 L in 1 BOTTLE3 bottle2026-04-30NoNoCurrent