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 101 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Menthol Pain Relief Gel-Roll OnMENTHOLGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.0bd62de8-ce8b-c110-e063-6294a90a98cb2025-02-07WarningsExact identifier
application number: M017
Menthol Pain Relief Gel-TubeMENTHOLGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.0bb07892-824e-8691-e063-6294a90a38912025-02-07WarningsExact identifier
application number: M017
Olu Pain ManagementLIDOCAINE AND CAMPHOROlakino Therapeutics LLC2a41a621-c6f7-5819-e063-6394a90ae67d2025-02-07WarningsExact identifier
application number: M017
Pain Reliveing PatchLIDOCAINE 4%simple diagnostics02ed0b27-bba9-ec0c-e063-6294a90a014d2025-02-07WarningsExact identifier
application number: M017
FlexDermal Pain Relieving Roll-OnMENTHOLSOLVADERM LLCd4d8050e-0761-4491-8635-39c806701eb52025-02-06WarningsExact identifier
application number: M017
Lipo Flavonoid Ear Pain Relief Drops with 4% LidocaineLIPO FLAVONOID EAR PAIN RELIEF DROPS WITH 4% LIDOCAINEClarion Brands LLC2d7e9f6a-0f21-b103-e063-6294a90a912f2025-02-06WarningsExact identifier
application number: M017
signature care HydrocortisoneHYDROCORTISONESafeway9fe16fc5-77e3-47f5-a943-85bc6565c0d42025-02-06WarningsExact identifier
application number: M017
Methyl SalicylateMETHYL SALICYLATEPHARMACURE LLC8803ae01-ea48-46c2-ab64-bb273de605ac2025-02-05WarningsExact identifier
application number: M017
Hempvana Maximum Strength Pain Relief Cream 10% Trolamine SalicylateTROLAMINE SALICYLATETELEBRANDS CORP2d685602-5cd6-3b36-e063-6394a90a3c5d2025-02-05WarningsExact identifier
application number: M017
LidocoreLIDOCAINEiON Pharma, LLC204c3e50-1ac8-f442-e063-6294a90ae7b52025-02-05WarningsExact identifier
application number: M017
Methyl SalicylateMETHYL SALICYLATEPHARMACURE LLC2c32cfed-2022-4e7c-ae9c-ba22dbb560af2025-02-04WarningsExact identifier
application number: M017
CapsaicinCAPSAICINPHARMACURE LLCb2b2de93-d957-43d7-a2a8-b46bcaea1f0d2025-02-04WarningsExact identifier
application number: M017
Hempvana Maximum Strength Pain Relief Cream ExtremeMENTHOL 16%, CAMPHOR 11%Telebrands Corp2d54077e-4c8d-aaae-e063-6394a90adb412025-02-04WarningsExact identifier
application number: M017
Capsaicin External AnalgesicCAPSAICINNuCare Pharmaceuticals,Inc.fd90a67d-d60d-a849-e053-6394a90a2cc82025-02-04WarningsExact identifier
application number: M017
Rugby Muscle Rub CreamMUSCLE RUB CREAMNuCare Pharmaceuticals, Inc.2d58c15a-5ddb-1b16-e063-6294a90a3fbb2025-02-04WarningsExact identifier
application number: M017
CetilarMENTHOL 1.4%PharmaNutra Usa Corp.2dd14bd4-b4e1-bc7d-e063-6394a90a1e592025-02-04WarningsExact identifier
application number: M017
Stopain Extra Strength ContinuousMENTHOLTroy Manufacturing, Inc.0d199d39-5b47-4c7f-b83a-757f39aa17b62025-02-03WarningsExact identifier
application number: M017
TheraCare Pain Relieving Lidocaine CreamLIDOCAINE HYDROCHLORIDEVeridian Healthcare2d42192b-8889-a896-e063-6294a90a4fc82025-02-03WarningsExact identifier
application number: M017
Tiger Balm Pain Relieving MuscleMETHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC)Haw Par Healthcare Ltd.96b06d3f-8685-4314-ad7d-5d2720f4dde62025-02-03WarningsExact identifier
application number: M017
Icy Hot Medicated No Mess ApplicatorMENTHOLChattem, Inc.4ce2b823-7ef5-4cca-a2d8-2fe781bc958e2025-02-01WarningsExact 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