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 11 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OWELL NATURALS NEUROPATHY MAXIMUM STRENGTHMENTHOLOWELL NATURAL 8 LLC56b8d0cc-2f35-7d38-e063-6294a90ad06d2026-07-16WarningsExact identifier
application number: M017
ANTIPHLAMINEL-MENTHOL, L-CAMPHOR, METHYL SALICYLATEMasaem Company56b93c89-295b-f33a-e063-6294a90a5fe42026-07-16WarningsExact identifier
application number: M017
Meriwether Skin Pain ReliefMENTHOL, UNSPECIFIED FORMMeriwether Skin LLCf6e155be-5879-4176-bb0e-e364f2e5cdf92026-07-16WarningsExact identifier
application number: M017
Medi-First Muscle Rub CreamMENTHOL, METHYL SALICYLATEUnifirst First Aid Corporation56a6b8b2-7ab0-9854-e063-6294a90ab5ba2026-07-15WarningsExact identifier
application number: M017
Painsil Pain Relief Roll-OnLIDOCAINE HYDROCHLORIDEPainsil LLCdee39dff-5749-4ef2-a9ed-182f25e01f672026-07-14WarningsExact identifier
application number: M017
VARICOSE VEINS MAXIMUM STRENGTHMENTHOLOWELL NATURAL & LLC5692914f-1b14-e3e3-e063-6394a90a94bf2026-07-14WarningsExact identifier
application number: M017
ZyloReliefLIDOCAINE HYDROCHLORIDEHighmark Pharma LLC635f5b98-f74c-495f-a537-686fcba9ccad2026-07-14WarningsExact identifier
application number: M017
ENOKON PAIN RELIEF Spray.PAIN RELIEF SPRAY.Henan Enokon Medical Instrument Co., Ltd.5675ec21-b947-2206-e063-6294a90aa5092026-07-12WarningsExact identifier
application number: M017
Topcare Pain Relief PatchPAIN RELIEF PATCH MEDICATED 5% MENTHOL761624f00d0b8-d2f4-843b-e063-6294a90a332b2026-07-12WarningsExact identifier
application number: M017
Penetral Roll-onCAPSAICIN 0.025%PureTek Corporation56204c03-8b15-a8b5-e063-6394a90a81892026-07-10WarningsExact identifier
application number: M017
Intensive Healing Itch ReliefITCH RELIEF CREAMNeilMed Pharmaceuticals Inc563ef1d5-2180-bc45-e063-6294a90a813d2026-07-10WarningsExact identifier
application number: M017
AVON Foot Works Arthritis Achy Foot and MuscleMETHYL SALICYLATECOSMAX USA, CORPORATION56440d3f-bc93-cebb-e063-6294a90a5f792026-07-10WarningsExact identifier
application number: M017
CHEONG KUN PAIN RELIEVINGCAMPHORCHEONG KUN PAIN RELIEVER OIL CHINESE MEDICINE FACTORY (MACAU) LIMITED557d5cb3-2a05-4f45-e063-6394a90a9b122026-07-10WarningsExact identifier
application number: M017
Biofreeze ProfessionalMENTHOLReckitt Benckiser LLC485c8208-c93b-5b84-e063-6394a90ab77a2026-07-10WarningsExact identifier
application number: M017
Fit Mist Pain ReliefMENTHOLAroma Sensations Incf5a98544-8bd7-42dc-a594-5559e3920e292026-07-09WarningsExact identifier
application number: M017
Nuturna SciaticaMENTHOLMicelle Laboratories, Incorporatedff200864-bedf-4138-bdec-2b23701406dd2026-07-09WarningsExact identifier
application number: M017
Lidocaine creamDRS LIDOCAINE 5% CREAMOL PHARMA TECH LLC. (Drs. Pharmacy)372fe018-1e5a-9ec4-e063-6294a90a15002026-07-09WarningsExact identifier
application number: M017
Nupharmisto 4% Lidocaine Numbing creamLIDOCAINE 4%EveryMarket Inc5615e49d-e03b-f915-e063-6294a90a17862026-07-08WarningsExact identifier
application number: M017
CAREALL Musle and JointMENTHOLNew World Imports, Inc561cc103-ae88-8f30-e063-6294a90a05c42026-07-08WarningsExact identifier
application number: M017
HealthWise Medicated Cold HotMENTHOLVeridian Healthcare, LLC561e1409-d1d8-e35d-e063-6394a90a4d8f2026-07-08WarningsExact 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