FDA.reportPublic FDA data

Pain Relief Patches

Product NDC
70000-0368
11-digit product format
700000368
Labeler code
70000
Product ID
70000-0368_45726fbc-3452-63f7-e063-6394a90a671a
Type
HUMAN OTC DRUG
Nonproprietary name
CAMPHOR, MENTHOL, METHYL SALICYLATE
Dosage form
PATCH
Route
TOPICAL
Labeler
Cardinal Health, 110 dba LEADER
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-03-01
Substance
CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE
Active strength
3.1; 6; 10 g/100g; g/100g; g/100g
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 Relief Patches
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)3.1 g/100g
MENTHOL6 g/100g
METHYL SALICYLATE10 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5TJD82A1ETInternal UNII lookup
L7T10EIP3AInternal UNII lookup
LAV5U5022YInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1793147Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f8837b69-8d85-448c-a4b4-be911bca1f6cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0368-1Pain Relief Patches6 in 1 BOXPATCH66
70000-0368-1Pain Relief Patches9 g in 1 PATCHPATCH96

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0368-1EA - Each70000-036822de7796-ba44-4f9d-8f66-5d0aa31842ef12019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0368PAIN RELIEF PATCHES (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [CARDINAL HEALTH, 110 DBA LEADER]5Current NDC, Legacy NDC, 2 package rows20241222_f8837b69-8d85-448c-a4b4-be911bca1f6c.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 87 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stopain Extra StrengthMENTHOLTroy Manufacturing, Inc.07e9a235-6d10-4407-8729-beaf936e97ad2025-07-03WarningsExact identifier
application number: M017
Blue Ice Topical Analgesic GelICE GELInternational Wholesale397cd306-078d-5b7d-e063-6294a90a8bbc2025-07-03WarningsExact identifier
application number: M017
LIDOCAINELIDOCAINE, MENTHOLVive Health LLC236ccc6d-21b7-6153-e063-6394a90a46342025-07-02WarningsExact identifier
application number: M017
AsperFlex MAXLIDOCAINE 4% WITH MENTHOL 1%Akron Pharma Inc.ccf6172b-350a-4b78-b844-f84bf17c491f2025-07-02WarningsExact identifier
application number: M017
METHYL SALICYLATE 25%METHYL SALICYLATEOncora Pharma, LLC3766e3a9-94a8-4c3e-e063-6394a90aa24a2025-07-01WarningsExact identifier
application number: M017
Diphenhydramine Hydrochloride and Zinc AcetateDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATESun Pharmaceutical Industries, Inc.c89e3de8-7d71-485c-8fc5-2832d6024f162025-07-01WarningsExact identifier
application number: M017
Westlake Outdoor Pain and Itch RelievingLIDOCAINE 4% PAIN AND ITCH RELIEVINGWESTLAKE HB PHARMA3c563b28-4f4f-9d0c-e063-6294a90adf732025-07-01WarningsExact identifier
application number: M017
Cortizone 10 Water ResistantHYDROCORTISONEChattem, Inc.118e55e7-241f-44c4-959e-09bf6221bd772025-07-01WarningsExact identifier
application number: M017
Quit Smoking Nicotine PatchesNICOTINE TRANSDERMAL PATCHESShenzhen Paxi Trading Co., Ltd.38c1616e-3b09-0669-e063-6294a90a2c862025-06-29WarningsExact identifier
application number: M017
Plantar Fasciitis CreamCAMPHORSOLALIA LLC388f33c2-2bdf-ded8-e063-6294a90aeeac2025-06-27WarningsExact identifier
application number: M017
4 Lidocaine Topical AnestheticLIDOCAINERUGBY LABORATORIES63327e57-f4c8-4ae6-9d28-cef8697bbdcc2025-06-27WarningsExact identifier
application number: M017
Diphenhydramine HCl and Zinc AcetateANTI-ITCH CONTINUOUS SPRAYWal-Mart Stores, Inc.709c3bb8-5b36-4823-941a-45ddb3e431c42025-06-27WarningsExact identifier
application number: M017
Burn Relief Professional Bio-KoolLIDOCAINE - 4%Kool-Down Inc.827e9c69-4706-0ccf-e053-2991aa0aa1c12025-06-27WarningsExact identifier
application number: M017
Lidocaine PatchLIDOCAINEShenzhen Finona Information Technology Co., Ltd3875bde5-2e1a-5fdf-e063-6294a90a3c0d2025-06-26WarningsExact identifier
application number: M017
SupreH Bee Venom Arthritis Pain Relieving CreamSUPREH BEE VENOM ARTHRITIS PAIN RELIEVING CREAMShenzhen Xinxin Yunhai Technology Co., Ltd.3876cc44-7f3a-b084-e063-6294a90a61422025-06-26WarningsExact identifier
application number: M017
MediBalmHYDROCORTISONEBalmRx, LLC324dd151-84c5-3e2f-e063-6394a90a569d2025-06-26WarningsExact identifier
application number: M017
PHIZICO Pain ReliefMENTHOLER3 BRANDS INC.72715dc5-d1e7-4b4b-8e28-4e367abba3222025-06-25WarningsExact identifier
application number: M017
Diva Cramp Care CreamMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corp37368566-b14e-4d5c-bdde-6eea9073974f2025-06-25WarningsExact identifier
application number: M017
H2Ocean NOTHING TATTOO GLIDE AFTERCARE MAX STRENGTHLIDOCAINE HCLH2Ocean, LLC386bf11b-1d71-44bf-e063-6394a90a28172025-06-25WarningsExact identifier
application number: M017
Burn Relief Extra Strength Kool-DownLIDOCAINE - 3.9%Kool-Down Inc827fec2f-db3c-adbb-e053-2a91aa0a7c172025-06-25WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1793147camphor 3.1 % / menthol 6 % / methyl salicylate 10 % Medicated PatchPSNf8837b69-8d85-448c-a4b4-be911bca1f6c6
1793147camphor 0.031 MG/MG / menthol 0.06 MG/MG / methyl salicylate 0.1 MG/MG Medicated PatchSCDf8837b69-8d85-448c-a4b4-be911bca1f6c6
1793147camphor 3.1 % / menthol 6 % / methyl salicylate 10 % Medicated PatchSYf8837b69-8d85-448c-a4b4-be911bca1f6c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0368-1700000368016 PATCH in 1 BOX (70000-0368-1) / 9 g in 1 PATCH6 patch2019-03-010000-00-00NoNoCurrent