Pain Reliever Cream

Product NDC
69396-151
11-digit product format
693960151
Labeler code
69396
Product ID
69396-151_13066b41-67db-9fea-e063-6394a90a9b5c
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol 10%, Methyl Salicylate 15%
Dosage form
CREAM
Route
TOPICAL
Labeler
Trifecta Pharmaceuticals USA, LLC.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-06
Substance
MENTHOL; METHYL SALICYLATE
Active strength
10; 15 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
Pain Reliever Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL10 g/100g
METHYL SALICYLATE15 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
311498Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
130665d6-3de8-cb91-e063-6294a90a2083Available 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
69396-151-01Pain Reliever Cream114 g in 1 TUBECREAM1141
69396-151-01Pain Reliever Cream1 in 1 BOXCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-151PAIN RELIEVER CREAM (MENTHOL 10%, METHYL SALICYLATE 15%) CREAM [TRIFECTA PHARMACEUTICALS USA, LLC.]1Current NDC, 2 package rows20240308_130665d6-3de8-cb91-e063-6294a90a2083.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 129 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Itch and Rash CreamHYDROCORTISONEWildman Business Group1f95757d-a434-f02a-e063-6294a90a2d122024-09-01WarningsExact identifier
application number: M017
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEWildman Business Group1fd1a4b3-b6fd-0d4c-e063-6394a90a36802024-09-01WarningsExact identifier
application number: M017
Thera Care Cold Hot Medicated PatchMENTHOLVeridian Healthcareb1ce129d-06a1-7755-e053-2995a90abd7d2024-08-29WarningsExact identifier
application number: M017
BIOSAVIA External Analgesic Pain ReliefCAPSAICINBIOSAVIA USA, LLC814aa66b-7719-4a29-a84e-18290367e9c72024-08-28WarningsExact identifier
application number: M017
Careland Plantar Fasciitis Hydrogel Pain PatchesLIDOCAINE, MENTHOLPlanet (Anhui) Pharmaceutical Co., Ltd.0e2f29c2-2e95-4be0-b7e9-f1761a1321a52024-08-21WarningsExact identifier
application number: M017
Careland Max Strength Lidocaine 4 Pain RelievingLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.265b8dd7-64a4-4bc2-a91c-26c761c2090b2024-08-21WarningsExact identifier
application number: M017
Real Time Pain Relief Maxx Topical AnalgesicMENTHOLREAL TIME PRODUCTS, INCf45eb95a-2813-4124-bdb0-54e078a8237d2024-08-20WarningsExact identifier
application number: M017
Theracare Lidocaine Pain reliefLIDOCAINEVeridian Healthcare1d8a3679-637d-94c0-e063-6294a90a9ecf2024-08-19WarningsExact identifier
application number: M017
LidoSyncLIDOCAINE, MENTHOLiON Pharma, LLC200f883c-439a-3b99-e063-6394a90aed102024-08-19WarningsExact identifier
application number: M017
Eagle Brand Medicated Oil RefreshCAMPHOR, MENTHOLBorden Company (Private) Limited09243a23-1f17-f77b-e063-6394a90a0b222024-08-19WarningsExact identifier
application number: M017
CVS Health Maximum Strength Scalp Relief Anti-itchHYDROCORTISONECVS Healthb5ef0005-8b76-4205-8be0-db3a7ed7d1c42024-08-19WarningsExact identifier
application number: M017
Rite Aid Pain Relieving Roll-OnLIDOCAINE HCLRite Aid Corporation1406590c-667c-84eb-e063-6294a90a50522024-08-16WarningsExact identifier
application number: M017
NuviraCAPSAICIN 0.025%, MENTHOL 10%, METHYL NICOTINATE 0.25%, METHYL SALICYLATE 10%Strand Health Groupff448183-03cf-df2d-e053-6394a90a77f02024-08-16WarningsExact identifier
application number: M017
FLANAXMETHYL SALICYLATE, MENTHOL, CAPSAICINBelmora LLC5e06c688-a086-4c1c-8dab-fcead61fef402024-08-13WarningsExact identifier
application number: M017
Pain ReliefMENTHOLPain Relieving Spray Inc.1f44466f-044f-70fe-e063-6294a90ad5752024-08-09WarningsExact identifier
application number: M017
Meijer Cold Therapy Pain RelievingMENTHOLMeijer Inc1c5b55e3-f859-71b6-e063-6294a90a633b2024-08-08WarningsExact identifier
application number: M017
HealthWise Soothing Cold Therapy GelMENTHOL 4%Veridian Healthcare1f09ccdd-09d8-6a8d-e063-6394a90a184f2024-08-08WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONENantong Health & Beyond Hygienic Products Inc.fbbbcc67-b46d-d41a-e053-6294a90aa55d2024-08-08WarningsExact identifier
application number: M017
Cheezheng Pain Relief CreamMENTHOLTibet Cheezheng Tibetan Medicine Co. Ltd37279a3f-9207-4e4c-90d6-52735044f1042024-08-07WarningsExact identifier
application number: M017
CVS Health Hydrocortisone Anti ItchHYDROCORTISONECVS Health546a1b8a-8254-432a-85c4-38ebee5ad5682024-08-07WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311498menthol 10 % / methyl salicylate 15 % Topical CreamPSN130665d6-3de8-cb91-e063-6294a90a20831
311498menthol 100 MG/ML / methyl salicylate 150 MG/ML Topical CreamSCD130665d6-3de8-cb91-e063-6294a90a20831
311498menthol 10 % / methyl salicylate 15 % Topical CreamSY130665d6-3de8-cb91-e063-6294a90a20831
311498menthol 10 GM / methyl salicylate 15 GM per 100 GM Topical CreamSY130665d6-3de8-cb91-e063-6294a90a20831

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69396-151-01693960151011 TUBE in 1 BOX (69396-151-01) / 114 g in 1 TUBE1 tube2024-03-06NoNoCurrent