FDA.reportPublic FDA data

Camphotrol

Product NDC
59088-488
11-digit product format
590880488
Labeler code
59088
Product ID
59088-488_1e2d2f1a-8848-6a76-e063-6394a90ae170
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
2022-01-18
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
Camphotrol
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
ccac9f37-a374-4765-e053-2a95a90ad2f7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-488-07Camphotrol85 g in 1 BOTTLE, WITH APPLICATORGEL854

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-488-07GM - Gram59088-48871bd6cbd-b404-4d1d-809e-cc516aa41b7e12022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-488CAMPHOTROL (CAMPHOR, MENTHOL) GEL [PURETEK CORPORATION]4Current NDC, Legacy NDC, 1 package rows20240727_ccac9f37-a374-4765-e053-2a95a90ad2f7.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 103 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Professional Therapy MuscleCare Pain RelievingMENTHOL, CAMPHORActive and Innovative Inc.42f1abeb-f6d7-01c3-e054-00144ff88e882025-01-23WarningsExact identifier
application number: M017
LIDOCAINELIDOCAINEPHARMACURE LLC53384c51-6da1-4fa4-8782-2606ca3d1c6f2025-01-22WarningsExact identifier
application number: M017
CapsaicinCAPSAICINPHARMACURE LLC829afe1b-6b2a-42a9-9626-8e39b0105e702025-01-22WarningsExact identifier
application number: M017
FORTHiQ Pain Relief Lidocaine PatchPAIN RELIEF LIDOCAINE PATCHHenan Enokon Medical Instrument Co., Ltd.2c593420-5788-3422-e063-6394a90a18902025-01-22WarningsExact identifier
application number: M017
RETALIEF LIDOCAINE 5LIDOCAINEReliable 1 Laboratories LLC2c262f3c-8cb2-4384-e063-6294a90a436d2025-01-20WarningsExact identifier
application number: M017
Eagle Brand Medicated Roll On AromaticCAMPHOR, MENTHOL, METHYL SALICYLATEBorden Company (Private) Limited1c3e5068-dd61-ebdb-e063-6294a90a97cc2025-01-20WarningsExact identifier
application number: M017
PROHEAL BURNLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.bbc0a5d6-1de6-4ca3-9bb4-a45662b5eab12025-01-19WarningsExact identifier
application number: M017
HERSTAT PLUS Cold Sore TreatmentCAMPHOR, MENTHOLHerstat (USA) Inc.e20ea714-663d-c4ac-e053-2a95a90a5ecc2025-01-18WarningsExact identifier
application number: M017
Pain Relief MedicatedCAMPHOR MENTHOL METHYL SALICYTATERITE AID CORPORATION60895211-69f3-478b-a33f-1c2071f629502025-01-16WarningsExact identifier
application number: M017
Elgin Pain ReliefMENTHOLEco-Logics, Inc.70eda21e-e566-42f4-9a49-b0d3ad0006522025-01-16WarningsExact identifier
application number: M017
Curist Lidocaine Patch Maximum StrengthLIDOCAINELittle Pharma, Inc.e574c188-cc65-287d-e053-2995a90a59722025-01-16WarningsExact identifier
application number: M017
Equate Hydrocortisone TopicalHYDROCORTISONEWalMart1f64555d-f77e-4a83-b222-fdb3ed7d88532025-01-16WarningsExact identifier
application number: M017
Equate HydrocortisoneHYDROCORTISONEWalMartf5c32b4a-1159-4b7a-b8ac-256d53020dc22025-01-16WarningsExact identifier
application number: M017
Lidocaine Pain Relief Gel-PatchLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd296fcc36-563f-19ca-e063-6394a90ab3ae2025-01-15WarningsExact identifier
application number: M017
K19 RELIEFMENTHOLK19 LLCe2e1ca96-1ae8-4c99-b8de-ce26754292f92025-01-15WarningsExact identifier
application number: M017
AnecreamLIDOCAINE 4%Focus Health Group2d7706e2-7363-4047-96cb-85b718277e8c2025-01-15WarningsExact identifier
application number: M017
BoroleumCAMPHOR, MENTHOL, WHITE PETROLATUMReliable 1 Laboratories846568af-0fdd-a80e-e053-2a91aa0a9c9e2025-01-15WarningsExact identifier
application number: M017
LidoPro Pain ReliefCAPSAICIN AND LIDOCAINEAdvanced Rx of Tennessee, LLC27d5997b-1cc2-41c2-e063-6394a90ac74a2025-01-15WarningsExact identifier
application number: M017
Pain Relief Patch 4% LidocaineLIDOCAINEReliable 1 Laboratories LLC2b624763-c310-63d9-e063-6394a90a19282025-01-15WarningsExact identifier
application number: M017
Cannarelief 1000mgMENTHOLCarolina Cannabis Creations LLC01e2ae1a-c969-6dd2-e063-6394a90a9d9e2025-01-15WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039731camphor 4 % / menthol 10 % Topical GelPSNccac9f37-a374-4765-e053-2a95a90ad2f74
1039731camphor 0.04 MG/MG / menthol 0.1 MG/MG Topical GelSCDccac9f37-a374-4765-e053-2a95a90ad2f74
1039731camphor 4 % / menthol 10 % Topical GelSYccac9f37-a374-4765-e053-2a95a90ad2f74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59088-488-075908804880785 g in 1 BOTTLE, WITH APPLICATOR (59088-488-07) 85 g2022-01-180000-00-00NoNoCurrent