FDA.reportPublic FDA data

Pain Relieving Cream

Product NDC
67385-701
11-digit product format
673850701
Labeler code
67385
Product ID
67385-701_b5e06ab5-1bf1-4605-92b2-11a8858002ff
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol, Unspecified Form and Methyl Salicylate
Dosage form
CREAM
Route
TOPICAL
Labeler
Garcoa, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-08-03
Substance
MENTHOL; METHYL SALICYLATE 2-ETHYLBUTYRATE
Active strength
1; 1.5 mg/100g; mg/100g
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 Relieving Cream
Brand name suffix
Analgesic
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL1 mg/100g
METHYL SALICYLATE 2-ETHYLBUTYRATE1.5 mg/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
J8D9175Q0GInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2f736307-5cd4-4a76-9044-4aeecba096ccAvailable on FDA.report

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 94 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Stop Itch GelDIPHENHYDRAMINE HCLWalgreens Co23586336-8f46-3dcd-e063-6394a90accc92025-05-04WarningsExact identifier
application number: M017
WaxRx EarAcheRx Pain Relieving Drops4% LIDOCAINE HCLDOCTOR EASY MEDICAL PRODUCTS, LLC34156655-8706-f0a4-e063-6294a90acc902025-05-01WarningsExact identifier
application number: M017
foster and thrive anti itch creamDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEStrategic Sourcing Services LLCbb08293d-5db8-4cc8-9fe3-bd02061dbeb92025-04-30WarningsExact identifier
application number: M017
Maximum Strength 4% Lidocaine PatchLIDOCAINESolis Pharmaceuticals Inc.3061d301-2104-b1b2-e063-6394a90a9b6e2025-04-29WarningsExact identifier
application number: M017
Maximum Strength 4% Lidocaine PatchLIDOCAINEInterMed Laboratories Private Limited33ed754e-8852-d5b2-e063-6394a90a7cf22025-04-29WarningsExact identifier
application number: M017
Cold Hot Medicated Patch 5% MentholMENTHOLInterMed Laboratories Private Limited33ee6e48-243e-4ded-e063-6394a90a987d2025-04-29WarningsExact identifier
application number: M017
Lidocaine Pain Relief Gel-PatchLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd32b96689-8e9b-4c2e-e063-6294a90a7d1c2025-04-29WarningsExact identifier
application number: M017
Lidocaine Pain Relief Gel-PatchLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd3304e362-dcda-3f5e-e063-6294a90a70152025-04-29WarningsExact identifier
application number: M017
Lidocaine Pain Relief Gel-PatchLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd2f2f753d-c791-e863-e063-6394a90aec5d2025-04-29WarningsExact identifier
application number: M017
Lidocaine Pain Relief Gel-PatchLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd3162c96a-061d-2971-e063-6394a90a9b742025-04-29WarningsExact identifier
application number: M017
Ivarest Poison Ivy Removal and Itch ReliefPRAMOXINE HYDROCHLORIDEBlistex Inc.dedbf5d9-0f86-4f32-8321-da86c9838c0a2025-04-29WarningsExact identifier
application number: M017
HealthWise 2X Medicated Pain Relief Cream Roll-onMENTHOLVeridian Healthcare33dae8a8-4197-f276-e063-6294a90aea832025-04-28WarningsExact identifier
application number: M017
HealthWise Roll-on Menthol Pain Relief GelMENTHOLVeridian Healthcare33dbb939-9397-7e70-e063-6294a90ac8f42025-04-28WarningsExact identifier
application number: M017
Stopain Extra Strength GelMENTHOLTroy Manufacturing, Inc.fa1a98bc-c233-410d-a20e-71111c8973722025-04-28WarningsExact identifier
application number: M017
Lidocaine Patch 4%LIDOCAINE 4%Medcore LLCb961906c-fe66-466b-af2c-072781fa098b2025-04-28WarningsExact identifier
application number: M017
Walgreens Lidocaine Knee and ElbowLIDOCAINEWalgreen Co.a3fb4c78-1493-4ba4-ae83-502dd825ed672025-04-25WarningsExact identifier
application number: M017
Walgreens Lidocaine BackLIDOCAINEWalgreen Co.e6bfd342-c0db-46b9-b5e6-5acbd860adf12025-04-25WarningsExact identifier
application number: M017
Electrum Numb FoamLIDOCAINE HCIRENU LABORATORIES, LLCc8472932-28b7-9189-e053-2a95a90a44df2025-04-25WarningsExact identifier
application number: M017
Benadryl Extra Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC66a2fd60-1757-45cc-a195-ecb9241dca2a2025-04-24WarningsExact identifier
application number: M017
Jakwork Numbing CreamNUMBING CREAMGuangzhou Zanming Trading Co., Ltd.3385cddb-609f-62e8-e063-6294a90add812025-04-24WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67385-701-0167385070101907 g in 1 BOTTLE, PUMP (67385-701-01) 907 g2026-08-03NoNoCurrent
67385-701-0267385070102453.6 g in 1 JAR (67385-701-02) 453.6 g2026-08-03NoNoCurrent
67385-701-0367385070103170 g in 1 BOTTLE, DISPENSING (67385-701-03) 170 g2026-08-03NoNoCurrent
67385-701-0467385070104113 g in 1 JAR (67385-701-04) 113 g2026-08-03NoNoCurrent