FDA.reportPublic FDA data

TopCare Health Pain Relief

Product NDC
36800-670
11-digit product format
368000670
Labeler code
36800
Product ID
36800-670_42632fa6-40b5-d6c2-e063-6294a90a02d2
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol, Camphor, and Methyl Salicylate
Dosage form
PATCH
Route
TOPICAL
Labeler
Topco Associates LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-03-08
Substance
CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE
Active strength
.012; .057; .063 mg/g; mg/g; 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
TopCare Health Pain Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC).012 mg/g
MENTHOL.057 mg/g
METHYL SALICYLATE.063 mg/g

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
853260Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
dac364ef-6dcd-3fc6-e053-2a95a90a9bb2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-670-40TopCare Health Pain Relief40 in 1 CARTONPATCH405
36800-670-40TopCare Health Pain Relief1 g in 1 PATCHPATCH15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-670TOPCARE HEALTH PAIN RELIEF (MENTHOL, CAMPHOR, AND METHYL SALICYLATE) PATCH [TOPCO ASSOCIATES LLC]4Current NDC, Legacy NDC, 2 package rows20241212_dac364ef-6dcd-3fc6-e053-2a95a90a9bb2.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 119 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HydrocortisoneHYDROCORTISONEKroger Companyfc1677f2-4078-4ebd-9c3b-86a29a35b4892024-11-12WarningsExact identifier
application number: M017
CVS Health Lidocaine CreamLIDOCAINECVS Healthad950680-c03c-4fa5-aa7f-239a889cd0972024-11-12WarningsExact identifier
application number: M017
CVS Arthritis Pain ReliefARTHRITIS PAIN RELIEFCVS Health575dd514-fd99-4e44-8fc8-52938f9abc262024-11-11WarningsExact identifier
application number: M017
ThermaPatch (TM) Lidocaine Pain Relief PatchLIDOCAINE PAIN RELIEF PATCHHenan Enokon Medical Instrument Co., Ltd.26769590-cd50-1b01-e063-6394a90a445c2024-11-09WarningsExact identifier
application number: M017
DG Health Cold Zone Pain Relieving Topical AnalgesicMENTHOL, UNSPECIFIED FORMDolgencorp Inc22594ab8-9a4a-426f-aced-5c636620fa2c2024-11-08WarningsExact identifier
application number: M017
Peviderm Pramoxine Hydrocholride 1%PRAMOXINE HYDROCHLORIDEStratus Pharmaceuticals Inc680b40fa-1922-443a-a4b0-7c3f6a2b847d2024-11-07WarningsExact identifier
application number: M017
Meijer Analgesic with Aloe Topical AnalgesicTROLAMINE SALICYLATEMeijer Distribution, Incf6c1e09e-4c61-4c2a-87d7-b052ed36fcac2024-11-07WarningsExact identifier
application number: M017
Meijer Pain Relieving Balm AnalgesicTROLAMINE SALICYLATEMeijer Distribution, Inc1b7535cc-01ac-49f0-9889-dd14b254d4ae2024-11-07WarningsExact identifier
application number: M017
BENGAY Tropical JasmineLIDOCAINEKenvue Brands LLCc416320a-c0d7-401e-b0fa-44114d76a5572024-11-06WarningsExact identifier
application number: M017
Bengay Ultra Strength Large SizeMENTHOL, UNSPECIFIED FORMKenvue Brands LLCf57ccc33-400b-4401-a348-c54d1eb9f5d02024-11-06WarningsExact identifier
application number: M017
Band Aid Antiseptic Cleansing To GoBENZALKONIUM CHLORIDE, PRAMOXINE HCLKenvue Brands LLCd5749cba-32f3-cf9c-e053-2a95a90a44162024-11-06WarningsExact identifier
application number: M017
Pain Relieving CreamCAMPHOR AND MENTHOLGOLDEN TIGER DISTRIBUTION L.L.C.26473383-282c-fb10-e063-6394a90a5fa22024-11-06WarningsExact identifier
application number: M017
Pain Relieving CreamCAMPHOR AND MENTHOLGOLDEN TIGER DISTRIBUTION L.L.C.1b6f929a-db65-8a02-e063-6394a90a8b592024-11-06WarningsExact identifier
application number: M017
Meijer Maximum Strength Pain Relieving AnalgesicMENTHOL, UNSPECIFIED FORMMeijer Distribution, Incbd6f04f9-a23b-45f6-bce2-1ef7203198e12024-11-06WarningsExact identifier
application number: M017
Meijer Cold and Hot Pain Relieving AnalgesicLIDOCAINE HYDROCHLORIDE AND MENTHOL, UNSPECIFIED FORMMeijer Distribution, Inc6d356563-9098-4994-8ad8-819a8033a9f42024-11-06WarningsExact identifier
application number: M017
TopCare Maximum Strength Pain Relieving AnalgesicMENTHOL, UNSPECIFIED FORMTopco Associates LLCdc80d2f9-e3eb-4feb-bad5-7d6ab107f9ab2024-11-05WarningsExact identifier
application number: M017
Aveeno Restorative Skin Therapy Itch Relief BalmPRAMOXINE HYDROCHLORIDEKenvue Brands LLC61824ca7-a2d3-4830-b2bb-149a3222bfc82024-11-05WarningsExact identifier
application number: M017
Aveeno Hydrocortisone ANTI-ITCHHYDROCORTISONEKenvue Brands LLC233de4d7-e533-40cd-a5ed-e8b09abc626e2024-11-05WarningsExact identifier
application number: M017
STING MASTERLIDOCAINE HYDROCHLORIDELes Technologies Ptero, Inc94c6fd1f-9e74-420b-9d25-61b37953b8382024-11-05WarningsExact identifier
application number: M017
Alocane Emergency BurnLIDOCAINE HYDROCHLORIDEQuest Products, LLC.0c8e65a6-dff3-43b4-a3f1-95deb574ea892024-11-05WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
853260camphor 1.2 % / menthol 5.7 % / methyl salicylate 6.3 % Medicated PatchPSNdac364ef-6dcd-3fc6-e053-2a95a90a9bb25
853260camphor 0.012 MG/MG / menthol 0.057 MG/MG / methyl salicylate 0.063 MG/MG Medicated PatchSCDdac364ef-6dcd-3fc6-e053-2a95a90a9bb25
853260camphor 1.2 % / menthol 5.7 % / methyl salicylate 6.3 % Medicated PatchSYdac364ef-6dcd-3fc6-e053-2a95a90a9bb25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-670-403680006704040 PATCH in 1 CARTON (36800-670-40) / 1 g in 1 PATCH40 patch2022-03-080000-00-00NoNoCurrent