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 73 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Cold and HotMENTHOLCVS Pharmacya44cec95-822a-40b6-e053-2995a90ae31c2025-10-17WarningsExact identifier
application number: M017
Sombra MaxSOMBRA MAXSombra Cosmetics Inc.41623a46-e6e7-907e-e063-6394a90afc4c2025-10-17WarningsExact identifier
application number: M017
POMADA DRAGON PAIN RELIEVINGCAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATETELEVISA CONSUMER PRODUCTS USAc283291d-feaa-4f89-8fde-9e3957ea8b9f2025-10-17WarningsExact identifier
application number: M017
Ear Pain MDLIDOCAINE HYDROCHLORIDEEosera Inc78c4418f-7f0f-447f-a94f-d4c89a081af12025-10-17WarningsExact identifier
application number: M017
WOFANLI Quit Smoking Nicotine PatchesNICOTINE TRANSDERMAL PATCHESShenzhen Paxi Trading Co., Ltd.414217c1-ff3a-b556-e063-6394a90aa5db2025-10-16WarningsExact identifier
application number: M017
WOFANLI Quit Smoking Nicotine PatchesNICOTINE TRANSDERMAL PATCHESShenzhen Paxi Trading Co., Ltd.41422d04-160b-51b2-e063-6294a90ab2b22025-10-16WarningsExact identifier
application number: M017
WOFANLI Quit Smoking Nicotine PatchesNICOTINE TRANSDERMAL PATCHESShenzhen Paxi Trading Co., Ltd.41427275-4c35-bbdf-e063-6294a90a14cf2025-10-16WarningsExact identifier
application number: M017
Dollar General Menthol Pain Relief Gel RollonMENTHOLDolgencorp, LLC3a9b99e2-36b8-5dcf-e063-6394a90a382d2025-10-16WarningsExact identifier
application number: M017
Quality ChoiceHYDROCORTISONEChain Drug Marketing Association, Inc.24c3eb99-92ac-658c-e063-6394a90ab51f2025-10-16WarningsExact identifier
application number: M017
DentiCalmTOPICAL ANALGESICNFUSE LLC414e6f6f-06bb-b470-e063-6294a90af3902025-10-16WarningsExact identifier
application number: M017
WOFANLI Quit Smoking Nicotine PatchesNICOTINE TRANSDERMAL PATCHESShenzhen Paxi Trading Co., Ltd.413008cd-d239-1453-e063-6394a90a74f22025-10-15WarningsExact identifier
application number: M017
PERFORM LEO EXTENSIVE PAIN RELIEFLIDOCAINE, MENTHOLPERFORM LEO LLCf993ed5f-7dbb-4e3e-addf-f65b12f5cc482025-10-15WarningsExact identifier
application number: M017
Nufabrx Lower Leg SleeveCAPSAICINNufabrx LLCb8e3e528-b7cd-e4b7-e053-2995a90a40292025-10-15WarningsExact identifier
application number: M017
Nufabrx Medicine Infused Ankle SleeveCAPSAICINNufabrx LLC013d60c7-a613-7cdf-e063-6294a90ad5842025-10-15WarningsExact identifier
application number: M017
Nufabrx Calf SleeveCAPSAICINNufabrx LLCbd9459c4-5596-746f-e053-2995a90a54002025-10-15WarningsExact identifier
application number: M017
Nufabrx Arm SleeveCAPSAICINNufabrx LLCa7993eaf-6488-a818-e053-2995a90a7ea62025-10-15WarningsExact identifier
application number: M017
Nufabrx Back WrapCAPSAICINNufabrx LLCe4f85ac8-57cb-46eb-e053-2995a90a9b1c2025-10-15WarningsExact identifier
application number: M017
Nufabrx Medicine Infused SocksCAPSAICINNufabrx LLC013cb66f-8695-b69f-e063-6294a90a699c2025-10-15WarningsExact identifier
application number: M017
Nufabrx Neck WrapCAPSAICINNufabrx LLCe10b420c-500d-5738-e053-2a95a90a008f2025-10-15WarningsExact identifier
application number: M017
Nufabrx Knee SleeveCAPSAICINNufabrx LLCa5f455d4-5fc5-d516-e053-2a95a90a921e2025-10-15WarningsExact 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