FDA.reportPublic FDA data

Pain Release

Product NDC
69204-005
11-digit product format
692040005
Labeler code
69204
Product ID
69204-005_471f5c2f-0e22-8065-e063-6394a90a1be4
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
GRANULE
Route
TOPICAL
Labeler
Natures Formulae Health Products Ltd.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-10-16
Substance
MENTHOL
Active strength
1.6 mg/g
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
MENTHOL1.6 mg/g

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
781d3c8d-7b70-e973-e053-2991aa0aaa78Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69204-005-06Pain Release620 g in 1 BOTTLE, PLASTICGRANULE6202
69204-005-07Pain Release1 in 1 PACKETGRANULE12
69204-005-07Pain Release120 g in 1 POUCHGRANULE1202
69204-005-08Pain Release300 g in 1 BOTTLE, PLASTICGRANULE3002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69204-005PAIN RELEASE (MENTHOL) GRANULE [NATURES FORMULAE HEALTH PRODUCTS LTD.]1Current NDC, Legacy NDC, 4 package rows20181014_781d3c8d-7b70-e973-e053-2991aa0aaa78.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 46 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine 4% Topical Anesthetic CreamLIDOCAINE 4%Oncor Pharmaceuticals1baaa669-05af-4024-a0ba-ee3451756f6a2026-01-05WarningsExact identifier
application number: M017
TheraCare Pain ReliefMENTHOLVeridian Healthcare6834a6de-4d1d-4e40-945d-ec5c267abd142026-01-05WarningsExact identifier
application number: M017
TheraCare Lidocaine Pain ReliefLIDOCAINEVeridian Healthcareee8cd550-64ee-432e-98e5-b68083179a3c2026-01-05WarningsExact identifier
application number: M017
REGENECARE HALIDOCAINE HCLMPM Medical LLC0eee554f-dfe0-433a-9665-8bdb952298882026-01-05WarningsExact identifier
application number: M017
Pain Relieving CreamCAMPHOR AND MENTHOLPAIN WIZARD LIMITED LIABILITY COMPANY2647bba1-87f4-3c16-e063-6394a90ae0c92026-01-05WarningsExact identifier
application number: M017
TheraCare Lidocaine plus MentholLIDOCAINE, MENTHOLVeridian Healthcareefddd116-d753-425a-9ded-09b8045024e42026-01-05WarningsExact identifier
application number: M017
TheraCare Original MentholMENTHOLVeridian Healthcareea56e4e1-a758-428b-8758-ee31bb00ca822026-01-05WarningsExact identifier
application number: M017
Mugwort Patch (Cervical spine use)2%MENTHOLYIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED478e220c-0d35-9ee0-e063-6294a90ab6892026-01-04WarningsExact identifier
application number: M017
Mugwort Patch (Lumbar spine use)2%MENTHOLYIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED478e4b21-6d81-4cd3-e063-6394a90a18fe2026-01-04WarningsExact identifier
application number: M017
Mugwort Patch (Knee use)2%MENTHOLYIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED478e86d2-3030-91eb-e063-6394a90a4db02026-01-04WarningsExact identifier
application number: M017
American Safety and First AidHYDROCORTISONE ACETATEOrazen Inc4a543f90-d43c-4487-b27e-f43394c6320d2026-01-04WarningsExact identifier
application number: M017
Doctor Hoys Pain Relief GelMENTHOL, CAMPHOR (SYNTHETIC)Dynamic Blending Specialists, Inc.50123bb9-d5d8-4ba6-ab94-8ed95fe0f5a82026-01-02WarningsExact identifier
application number: M017
Doctor Hoys Pain Relief Gel Roll-OnMENTHOL, CAMPHOR (SYNTHETIC)Dynamic Blending Specialists, Inc.bf47acb2-6c90-4d5c-820b-447cac9305a42026-01-02WarningsExact identifier
application number: M017
Amino Rip Muscle Pain ReliefLIDOCAINE HCLLLORENS PHARMACEUTICALS INTERNATIONAL DIVISION2bed5764-4217-4aa3-9d90-3b5460dcffa32026-01-02WarningsExact identifier
application number: M017
Menthozen CreamMETHYL SALICYLATE, MENTHOL, CAPSAICINVillage Pharma LLC63bb0283-cfbe-4e9c-8772-73062c0c8d052026-01-01WarningsExact identifier
application number: M017
Menthozen HydrogelMENTHOL, CAPSAICINVillage Pharma LLC4c979a71-7c8f-4dff-abae-bf4cdf8f67b42026-01-01WarningsExact identifier
application number: M017
Lidozen GelLIDOCAINE HYDROCHLORIDE, MENTHOLVillage Pharma LLCffb7831f-4ca9-4d73-8303-e9cd900789822026-01-01WarningsExact identifier
application number: M017
Sting ReliefBENZOCAINE, ISOPROPYL ALCOHOLYiwu Ori-Power Medtech Co.,Ltd.116ee6dc-9c49-2e11-e063-6394a90a44ed2026-01-01WarningsExact identifier
application number: M017
MenthozenMETHYL SALICYLATE, MENTHOL, CAPSAICINVillage Pharma LLC48b1b99e-d0ec-4e5c-b80c-c0d2d87ecb132026-01-01WarningsExact identifier
application number: M017
NUVALU ICE THERAPY MENTHOL PAIN RELIEVINGMENTHOLJC SALES5adf457e-b4d0-30c8-e063-6294a90a64b92026-01-01WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69204-005-0669204000506620 g in 1 BOTTLE, PLASTIC (69204-005-06) 620 g2016-10-160000-00-00NoNoCurrent
69204-005-07692040005071 POUCH in 1 PACKET (69204-005-07) / 120 g in 1 POUCH1 pouch2016-10-160000-00-00NoNoCurrent
69204-005-0869204000508300 g in 1 BOTTLE, PLASTIC (69204-005-08) 300 g2025-12-12NoNoCurrent