FDA.reportPublic FDA data

Zepol Topical Analgesic

Product NDC
55715-001
11-digit product format
557150001
Labeler code
55715
Product ID
55715-001_325d8b0c-da35-376b-e063-6394a90acdde
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor, Menthol
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Laboratorios Zepol S.A.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-10-05
Substance
CAMPHOR (SYNTHETIC); MENTHOL
Active strength
6.55; 6.55 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
Zepol Topical Analgesic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)6.55 g/100g
MENTHOL6.55 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
1044238Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ca20ade6-9b35-40bb-b3b2-fc3a0e1eece9Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55715-001-01Zepol Topical Analgesic30 g in 1 TUBEOINTMENT307
55715-001-12Zepol Topical Analgesic12 in 1 BOXOINTMENT127
55715-001-12Zepol Topical Analgesic10 g in 1 CANOINTMENT107
55715-001-90Zepol Topical Analgesic90 g in 1 TUBEOINTMENT907
55715-001-90Zepol Topical Analgesic1 in 1 BOXOINTMENT17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ETZEPOL TOPICAL ANALGESIC (CAMPHOR, MENTHOL) OINTMENT [LABORATORIOS ZEPOL S.A.]2
MENTHOLACTIVE INGREDIENTL7T10EIP3AZEPOL TOPICAL ANALGESIC (CAMPHOR, MENTHOL) OINTMENT [LABORATORIOS ZEPOL S.A.]2
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ETZEPOL TOPICAL ANALGESIC (CAMPHOR, MENTHOL) OINTMENT [LABORATORIOS ZEPOL S.A.]2
MENTHOLACTIVE MOIETYL7T10EIP3AZEPOL TOPICAL ANALGESIC (CAMPHOR, MENTHOL) OINTMENT [LABORATORIOS ZEPOL S.A.]2
EUCALYPTOLINACTIVE INGREDIENTRV6J6604TKZEPOL TOPICAL ANALGESIC (CAMPHOR, MENTHOL) OINTMENT [LABORATORIOS ZEPOL S.A.]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UZEPOL TOPICAL ANALGESIC (CAMPHOR, MENTHOL) OINTMENT [LABORATORIOS ZEPOL S.A.]2
THYME OILINACTIVE INGREDIENT2UK410MY6BZEPOL TOPICAL ANALGESIC (CAMPHOR, MENTHOL) OINTMENT [LABORATORIOS ZEPOL S.A.]2
TURPENTINEINACTIVE INGREDIENTXJ6RUH0O4GZEPOL TOPICAL ANALGESIC (CAMPHOR, MENTHOL) OINTMENT [LABORATORIOS ZEPOL S.A.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55715-001ZEPOL TOPICAL ANALGESIC (CAMPHOR, MENTHOL) OINTMENT [LABORATORIOS ZEPOL S.A.]7Current NDC, Legacy NDC, 5 package rows20250410_ca20ade6-9b35-40bb-b3b2-fc3a0e1eece9.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 36 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CAPSAICIN HEAT PatchCAPSAICIN HEAT PATCHHenan Enokon Medical Instrument Co., Ltd.49ac2045-2c07-af9a-e063-6294a90a052a2026-01-31WarningsExact identifier
application number: M017
COLD AND HOT MEDICATED PatchCOLD AND HOT MEDICATED PATCHHenan Enokon Medical Instrument Co., Ltd.49ac6a7b-25d3-6dc4-e063-6394a90a99b62026-01-31WarningsExact identifier
application number: M017
COLD AND HOT MEDICATED PatchCOLD AND HOT MEDICATED PATCHHenan Enokon Medical Instrument Co., Ltd.49aca763-be2a-cf38-e063-6294a90a092e2026-01-31WarningsExact identifier
application number: M017
PAIN RELIEF HOT PatchPAIN RELIEF HOT PATCHHenan Enokon Medical Instrument Co., Ltd.49ad128a-0f4c-085a-e063-6294a90ac9bb2026-01-31WarningsExact identifier
application number: M017
Walgreens Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLWalgreen Company3557d2e9-714a-4066-aa73-ea9e3363e5742026-01-30WarningsExact identifier
application number: M017
Alveora HEMORRHOID MASTERLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID MASTERJiangxi Yudexi Pharmaceutical Co., LTD4996f96a-898e-de01-e063-6394a90a39072026-01-30WarningsExact identifier
application number: M017
Sunburn ReliefLIDOCAINE HCL 0.5%Rite Aid Corporationb67af0c7-1ae8-4494-bb0e-d7f66ebca3522026-01-30Warnings, Adverse reactionsExact identifier
application number: M017
Drs Pharmacy PAIN RELIEF MUSCLE ARITHRITISCAPSAICINOL PHARMA TECH,LLC48fdf9dc-05df-866d-e063-6294a90ae03a2026-01-30WarningsExact identifier
application number: M017
ROCKTAPE GO Kinesiology Tape and AnalgesicMENTHOL, METHYL SALICYLATEImplus Footcare, LLCb779c7d8-dbe6-472f-9282-6cced25cfd2e2026-01-29WarningsExact identifier
application number: M017
RockSauce Warming MassageMENTHOL, METHYL SALICYLATEImplus Footcare, LLCde5f7add-1f2b-438a-ac17-753ebb53e6972026-01-29WarningsExact identifier
application number: M017
RockSauce Warming Massage Roll-OnMENTHOL, METHYL SALICYLATEImplus Footcare, LLC5a2d9c3a-67fc-4c1a-b1e8-62a93880397a2026-01-29WarningsExact identifier
application number: M017
Analgesic Dr. ColladoMENTHOL, METHYL SALICYLATELaboratorios Dr. Collado, S.Ac0dad2db-7c96-49b8-a451-bf8cfa7f798b2026-01-29WarningsExact identifier
application number: M017
RockSauce Warming MassageMENTHOL, METHYL SALICYLATEImplus Footcare, LLC3121c7f7-d7e5-4ca9-9057-03edf9c94c562026-01-29WarningsExact identifier
application number: M017
Analgesic Gel Dr. Collado Menthol 4 Methyl SalicylateMENTHOL, METHYL SALICYLATELaboratorios Dr. Collado, S.A.87c22e6f-3ab0-47c3-94ea-48b3d1a95d9d2026-01-29WarningsExact identifier
application number: M017
ProCure Hydrocortisone Cream PlusHYDROCORTISONERooftop Consumer Health, Inc.fe334cae-e019-4397-8498-df3c923ae8b52026-01-29WarningsExact identifier
application number: M017
Red Oil Pain ReliefCAMPHOR (SYNTHETIC), MENTHOL, PHENOLThe Red Oil Company Inc1e36579a-72da-46ba-ac72-5960a11c08802026-01-29WarningsExact identifier
application number: M017
Extra Strength BalmCAPSICUM, MENTHOLNATURES FORMULAE HEALTH PRODUCTS LTD.498a5e2a-4de0-561c-e063-6394a90ac05c2026-01-29WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET POTENT PAIN RELIEF45c76956-db3f-3e84-e063-6394a90adce12026-01-29WarningsExact identifier
application number: M017
PAIN RELIEF PATCHESLIDOCAINEWALMART STORES INCb82cfe42-f521-4784-8c60-98481524c5ec2026-01-29WarningsExact identifier
application number: M017
Equate Pain Relief Patch Camphor/Menthol/SalicylateCAMPHOR, MENTHOL, METHYL SALICYLATEWalmart Stores Incb869848c-21e2-5ca2-e053-2995a90a86f22026-01-29WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1044238camphor 6.55 % / menthol 6.55 % Topical OintmentPSNca20ade6-9b35-40bb-b3b2-fc3a0e1eece97
1044238camphor 0.07 MG/MG / menthol 0.07 MG/MG Topical OintmentSCDca20ade6-9b35-40bb-b3b2-fc3a0e1eece97
1044238camphor 0.065 MG/MG / menthol 0.065 MG/MG Topical OintmentSYca20ade6-9b35-40bb-b3b2-fc3a0e1eece97
1044238camphor 6.55 % / menthol 6.55 % Topical OintmentSYca20ade6-9b35-40bb-b3b2-fc3a0e1eece97

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55715-001-015571500010130 g in 1 TUBE (55715-001-01) 30 g2009-10-050000-00-00NoNoCurrent
55715-001-125571500011212 CAN in 1 BOX (55715-001-12) / 10 g in 1 CAN12 can2019-10-010000-00-00NoNoCurrent
55715-001-90557150001901 TUBE in 1 BOX (55715-001-90) / 90 g in 1 TUBE1 tube2009-10-050000-00-00NoNoCurrent