Pain Release

Product NDC
69204-008
11-digit product format
692040008
Labeler code
69204
Product ID
69204-008_471f7065-fab9-8af4-e063-6394a90a2157
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
OIL
Route
TOPICAL
Labeler
Natures Formulae Health Products Ltd.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-10-16
Substance
MENTHOL
Active strength
12.18 mg/mL
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 Release
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL12.18 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
781dfd66-f006-a2d7-e053-2991aa0a170cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69204-008-10Pain Release200 mL in 1 BOTTLE, DROPPEROIL2002
69204-008-10Pain Release1 in 1 BOXOIL12
69204-008-11Pain Release40 mL in 1 BOTTLE, PLASTICOIL402
69204-008-12Pain Release100 mL in 1 BOTTLE, PLASTICOIL1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69204-008PAIN RELEASE (MENTHOL) OIL [NATURES FORMULAE HEALTH PRODUCTS LTD.]1Current NDC, Legacy NDC, 4 package rows20181014_781dfd66-f006-a2d7-e053-2991aa0a170c.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 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 startMarketing endSampleExclude flagStatus
69204-008-10692040008101 BOTTLE, DROPPER in 1 BOX (69204-008-10) / 200 mL in 1 BOTTLE, DROPPER2016-10-160000-00-00NoNoCurrent
69204-008-116920400081140 mL in 1 BOTTLE, PLASTIC (69204-008-11) 40 ml2016-10-160000-00-00NoNoCurrent
69204-008-1269204000812100 mL in 1 BOTTLE, PLASTIC (69204-008-12) 100 ml2025-12-12NoNoCurrent