Pain Release

Product NDC
69204-007
11-digit product format
692040007
Labeler code
69204
Product ID
69204-007_471f7c62-91ff-2cd8-e063-6294a90af3d9
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
17.62 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
MENTHOL17.62 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
781d53cf-b3df-3e2b-e053-2a91aa0a7dcdAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69204-007-03Pain Release30 mL in 1 BOTTLE, DROPPEROIL302
69204-007-03Pain Release1 in 1 BOXOIL12
69204-007-04Pain Release1 in 1 BOXOIL12
69204-007-04Pain Release10 mL in 1 BOTTLE, DROPPEROIL102
69204-007-05Pain Release6 mL in 1 BOTTLE, DROPPEROIL62
69204-007-05Pain Release1 in 1 BOXOIL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69204-007PAIN RELEASE (MENTHOL) OIL [NATURES FORMULAE HEALTH PRODUCTS LTD.]1Current NDC, Legacy NDC, 6 package rows20181014_781d53cf-b3df-3e2b-e053-2a91aa0a7dcd.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 112 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QC Cool and Heat Roll-OnMENTHOL 16%Chain Drug Marketing Association Incd35e9dfa-8a28-fdb3-e053-2995a90abc522024-12-15WarningsExact identifier
application number: M017
Meijer Cold and Hot Pain RelievingMENTHOL 16%Meijerbec62df3-06c9-a115-e053-2995a90a42672024-12-15WarningsExact identifier
application number: M017
Tommie Copper Pain ReliefMENTHOL 16%Tommie Copper, Inc.b4dfa5fa-2d61-db1e-e053-2a95a90a7ac82024-12-15WarningsExact identifier
application number: M017
Pain Relief Liquid RollerCAMPHOR 3.5%, MENTHOL 3.5%Tommie Copper, Inc.c9f0447e-de43-16a5-e053-2995a90a05c12024-12-15WarningsExact identifier
application number: M017
Tommie Copper Pain Relief Maximum StrengthTROLAMINE SALICYLATE 10%Tommie Copper, Inc.b622c14f-9bf3-0bbd-e053-2a95a90a2adc2024-12-15WarningsExact identifier
application number: M017
Copperlife Pain ReliefTROLAMINE SALICYLATE 10%Tommie Copper, Inc.c94d00f9-42ce-1d43-e053-2a95a90a058d2024-12-15WarningsExact identifier
application number: M017
Tommie Copper Pain Relief RollerCAMPHOR 3.5%, MENTHOL 3.5%Tommie Copper, Inc.b6c3d6eb-b485-33b8-e053-2a95a90a41e12024-12-15WarningsExact identifier
application number: M017
Tommie Copper Pain Relief RollerCAMPHOR 3.5%, MENTHOL 3.5%Tommie Copper, Inc.b4cd4fed-e8c8-db85-e053-2995a90a708b2024-12-15WarningsExact identifier
application number: M017
Copperlife Pain Relief LiquidMENTHOL 16%Tommie Copper, Inc.c93a0139-953b-5523-e053-2a95a90a0b2d2024-12-15WarningsExact identifier
application number: M017
Tommie Copper Pain ReliefTROLAMINE SALICYLATE 10%Tommie Copper, Inc.ca011b03-a263-1908-e053-2995a90ad9702024-12-15WarningsExact identifier
application number: M017
Warrior Chiggerex ReliefBENZOCAINE 10%Derma Care Research Labs, LLCdcf2f52b-2295-58e5-e053-2995a90a7fd82024-12-15WarningsExact identifier
application number: M017
Capsaicin CreamCAPSAICINTrifecta Pharmaceuticals USA LLCdef8d341-06a7-0e9b-e053-2995a90a0ad62024-12-13WarningsExact identifier
application number: M017
Mentholatum OriginalCAMPHOR, MENTHOLThe Mentholatum Company19e4b812-67c6-49fd-833a-b432100363f52024-12-13WarningsExact identifier
application number: M017
Cold and Hot MedicatedMENTHOLThe Mentholatum Company85bf425d-59d7-4462-ba46-2921454600992024-12-13WarningsExact identifier
application number: M017
Mentholatum Lidocaine IceLIDOCAINE HCL, MENTHOLThe Mentholatum Company4d74cbab-31cd-4579-9360-6852ee215b5e2024-12-13WarningsExact identifier
application number: M017
Mentholatum Deep Heating Rub Extra StrengthMENTHOL, METHYL SALICYLATEThe Mentholatum Companyf5684158-0d83-4031-b493-5422ddc73e782024-12-13WarningsExact identifier
application number: M017
Discount Drug Mart Anti-ItchCAMPHOR, MENTHOLDiscount Drug Mart87d379da-103a-c751-e053-2995a90a56de2024-12-13WarningsExact identifier
application number: M017
Audiologist Anti-itchHYDROCORTISONEOAKTREE PRODUCTS, INC.853e078e-1e91-d55f-e053-2991aa0a6dcd2024-12-13WarningsExact identifier
application number: M017
CVS Anti itchHYDROCORTISONECVS884df604-711b-4a3d-e053-2995a90a3a042024-12-13WarningsExact identifier
application number: M017
Dermoplast Pain RelievingBENZOCAINE AND LEVOMENTHOLAdvantice Health, LLC2347f0b8-d463-422d-8583-65624d9a1a912024-12-12WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69204-007-03692040007031 BOTTLE, DROPPER in 1 BOX (69204-007-03) / 30 mL in 1 BOTTLE, DROPPER2016-10-160000-00-00NoNoCurrent
69204-007-04692040007041 BOTTLE, DROPPER in 1 BOX (69204-007-04) / 10 mL in 1 BOTTLE, DROPPER2016-10-160000-00-00NoNoCurrent
69204-007-05692040007051 BOTTLE, DROPPER in 1 BOX (69204-007-05) / 6 mL in 1 BOTTLE, DROPPER2016-10-160000-00-00NoNoCurrent