FDA.reportPublic FDA data

Camphotrex

Product NDC
59088-283
11-digit product format
590880283
Labeler code
59088
Product ID
59088-283_1e2d1f71-9f7b-e353-e063-6294a90a4a2c
Type
HUMAN OTC DRUG
Nonproprietary name
camphor, menthol
Dosage form
GEL
Route
TOPICAL
Labeler
PureTek Corporation
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-04-12
Substance
CAMPHOR (SYNTHETIC); MENTHOL
Active strength
4; 10 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
Camphotrex
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)4 g/100g
MENTHOL10 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1039731Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3b6c6eef-e92d-497d-afe8-82356637c2b8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59adc2ba-d5f0-4a52-b35a-cc77921a79d2Product name420250724
111d457e-3138-4512-b0ba-d0cd760c4055Product name320250225
2839c963-7eb3-970a-287f-ff1b6d381268Product name220250103
0426261e-1bb9-b78b-abd2-80da765a7e3eProduct name220240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7Product name520240320
0ac2f11f-f58d-baf2-71a0-680993b48a61Product name220231211
855d63c3-b090-4636-8fc7-6d39ad23c44fProduct name120230829
bb58f410-04be-65dd-9211-e89ead899698Product name620230323
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
0fcbc38a-8b29-3348-1cef-5222ea53484fProduct name420220516
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126
8d368a34-1453-43ea-828d-0dbcd72b8794Product name820210622
1e973b2d-e028-69cd-9258-4613ba80fdc5Product name320210512
d6bab9d2-edce-a213-4796-226ab15472c3Product name620200616
3eb481d3-8b69-436f-82dd-4a66345568abProduct name120190611
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
2487e6ef-d419-42fc-aaf8-7acc805d2370Product name220170718
c100f0c7-e9dd-42f4-b0a8-0d81bd2a877cProduct name120160303
49615343-b619-4365-8118-8f2ed6046e78Product name120160224
a6319377-430a-43db-82f9-30d1d9d89cf8Product name120151216
e071c814-e5e7-e7ed-ec76-428765d9c66bProduct name220151120
93148e06-b8d7-4e6c-853e-62f807d17fbbProduct name120151014
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
dbb00be6-fb1c-4b0a-a770-31f7e05e247eProduct name120150316
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
f6199b09-e585-7ceb-4b09-803cf5ce1ed1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-283-07Migranow85 g in 1 BOTTLE, WITH APPLICATORGEL85 g10 g in 100g6
59088-283-07Camphotrex85 g in 1 BOTTLE, WITH APPLICATORGEL855
59088-283-07Diclogen85 g in 1 BOTTLE, WITH APPLICATORGEL85 g4 g in 100g3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-283-07GM - Gram59088-283661941f3-de00-452c-8ce6-c427f590cbba12016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-283MIGRANOW (SUMATRIPTAN SUCCINATE, CAMPHOR, MENTHOL) KIT [PURETEK CORPORATION]6Current NDC, Legacy NDC20241215_b82d7d65-9ef4-4f05-9a7d-10440683332e.zip
59088-283CAMPHOTREX (CAMPHOR, MENTHOL) GEL [PURETEK CORPORATION]5Current NDC, Legacy NDC, 1 package rows20240727_3b6c6eef-e92d-497d-afe8-82356637c2b8.zip
59088-283DICLOGEN (DICLOFENAC SODIUM, CAMPHOR AND MENTHOL) KIT [PURETEK CORPORATION]2Current NDC, Legacy NDC20241208_1e2bb4e5-bb65-48a0-e063-6294a90a54d1.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 8 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine 4% PatchLIDOCAINEAldermed Inc.57994923-20fc-9d9d-e063-6394a90a22c92026-07-27WarningsExact identifier
application number: M017
Lidocaine 4% PatchLIDOCAINEAldermed Inc.579a5012-837a-828b-e063-6294a90a4fb22026-07-27WarningsExact identifier
application number: M017
Original Pain ReliefTOPICAL ANALGESIC LOTIONReal Time Pain Relief Inc579bd303-9a50-4d66-e063-6294a90a61412026-07-27WarningsExact identifier
application number: M017
Lidfix Pain Relief Patch LidocaineLIDOCAINEHETERO HEALTHCARE LIMITED2149f0e3-1983-4f02-929e-ecd20357f4bb2026-07-27WarningsExact identifier
application number: M017
RectoProtectLIDOCAINEAkron Pharma Inc.1ca7d6cf-85a1-41a6-a07f-cff06a7edfbb2026-07-27WarningsExact identifier
application number: M017
OWELL NATURALS MAXIMUM STRENGTH LEG PAIN RELIEFMENTHOLOWELL NATURAL 8 LLC57a124b4-66c6-2474-e063-6294a90ab0d72026-07-27WarningsExact identifier
application number: M017
Icy Hot Performance DryMENTHOL 16%, CAMPHOR 11%Chattem, Inc.8927570f-761b-4d83-8612-30077224fdb82026-07-27WarningsExact identifier
application number: M017
NUMBINGLIDOCAINEYIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED578675e8-30e7-6986-e063-6394a90a8afe2026-07-26WarningsExact identifier
application number: M017
Do Me Delay CreamBENZOCAINEProdigy Media53d5cd6b-96b8-9ba2-e063-6294a90a0d152026-07-24WarningsExact identifier
application number: M017
Bravado Labs Delay CreamBENZOCAINEProdigy Media Inc57269544-9cfb-4ff0-e063-6394a90adb022026-07-24WarningsExact identifier
application number: M017
Zytherial Lidocaine 4% Pain Relief PatchLIDOCAINE 4% PAIN RELIEF PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.56db5028-b631-7981-e063-6294a90ae3952026-07-24WarningsExact identifier
application number: M017
AEROBURNLIDOCAINE HYDROCHLORIDEAero Healthcare US LLCf8fa72db-5f7a-4158-a2b3-f8bc0e12df9f2026-07-24WarningsExact identifier
application number: M017
AEROSOOTHEHYDROCORTISONEAero Healthcare US LLC22b172a2-07e8-4ebb-b0a0-dfe4f25477fa2026-07-24WarningsExact identifier
application number: M017
Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLCVS Pharmacy49003aac-184c-ae33-e063-6294a90a29c02026-07-24WarningsExact identifier
application number: M017
Arlun Lidocaine CreamLIDOCAINE CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5765fbf1-e835-a11e-e063-6394a90a5ac22026-07-24WarningsExact identifier
application number: M017
DERMFREE PAIN RELIEFARNICA MONTANA HPUS 7% PAIN RELIEFJiangxi Yudexi Pharmaceutical Co., LTD4bb74112-c4e7-7988-e063-6394a90ae3f12026-07-24WarningsExact identifier
application number: M017
SERYNTH HEMORRHOIDLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOIDJiangxi Yudexi Pharmaceutical Co., LTD4c667f3d-1238-2f02-e063-6394a90ab7422026-07-24WarningsExact identifier
application number: M017
DERMFREE NUMBINGMENTHOL 5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4ca7222b-d754-9861-e063-6294a90a1b7b2026-07-24WarningsExact identifier
application number: M017
REINREUDE BACK PAIN THERAPYCAMPHOR 80MG MENTHOL 24MG CAPSICUM EXTRACT 16MG BACK PAIN THERAPYJiangxi Yudexi Pharmaceutical Co., LTD4ca7d0ca-6407-1fed-e063-6394a90aaccc2026-07-24WarningsExact identifier
application number: M017
SERYNTH NICOTINE TRANSDERMAL STOP SMOKING AIDNICOTINE21MG NICOTINE TRANSDERMAL STOP SMOKING AIDJiangxi Yudexi Pharmaceutical Co., LTD4d5821f9-605e-5391-e063-6294a90afcd22026-07-24WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039731camphor 4 % / menthol 10 % Topical GelPSNb82d7d65-9ef4-4f05-9a7d-10440683332e6
313161SUMAtriptan succinate 50 MG Oral TabletPSNb82d7d65-9ef4-4f05-9a7d-10440683332e6
1039731camphor 0.04 MG/MG / menthol 0.1 MG/MG Topical GelSCDb82d7d65-9ef4-4f05-9a7d-10440683332e6
313161sumatriptan 50 MG Oral TabletSCDb82d7d65-9ef4-4f05-9a7d-10440683332e6
1039731camphor 4 % / menthol 10 % Topical GelSYb82d7d65-9ef4-4f05-9a7d-10440683332e6
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSYb82d7d65-9ef4-4f05-9a7d-10440683332e6
1039731camphor 4 % / menthol 10 % Topical GelPSN3b6c6eef-e92d-497d-afe8-82356637c2b85
1039731camphor 0.04 MG/MG / menthol 0.1 MG/MG Topical GelSCD3b6c6eef-e92d-497d-afe8-82356637c2b85
1039731camphor 4 % / menthol 10 % Topical GelSY3b6c6eef-e92d-497d-afe8-82356637c2b85
1039731camphor 4 % / menthol 10 % Topical GelPSN1e2bb4e5-bb65-48a0-e063-6294a90a54d13
857700diclofenac sodium 1.5 % Topical SolutionPSN1e2bb4e5-bb65-48a0-e063-6294a90a54d13
1039731camphor 0.04 MG/MG / menthol 0.1 MG/MG Topical GelSCD1e2bb4e5-bb65-48a0-e063-6294a90a54d13
857700diclofenac sodium 15 MG/ML Topical SolutionSCD1e2bb4e5-bb65-48a0-e063-6294a90a54d13
1039731camphor 4 % / menthol 10 % Topical GelSY1e2bb4e5-bb65-48a0-e063-6294a90a54d13
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY1e2bb4e5-bb65-48a0-e063-6294a90a54d13
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY1e2bb4e5-bb65-48a0-e063-6294a90a54d13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59088-283-075908802830785 g in 1 BOTTLE, WITH APPLICATOR (59088-283-07) 85 g2016-04-120000-00-00NoNoCurrent