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 9 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REINREUDE BACK PAIN THERAPYCAMPHOR 80MG MENTHOL 24MG BACK PAIN THERAPYJiangxi Yudexi Pharmaceutical Co., LTD4dfc77bb-11dd-e0f0-e063-6294a90a4e9c2026-07-24WarningsExact identifier
application number: M017
DRAVYNOR QUIT SMOKING PatchesNICOTINE18% MENTHOL 0.3% QUIT SMOKING PATCHESWenzhou Yuyuan Pharmaceutical Co., Ltd.5768631f-d517-5b43-e063-6294a90a8f462026-07-24WarningsExact identifier
application number: M017
DERMFREE NUMBINGLIDOCAINE4% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4a5b47ce-2bf1-42c7-e063-6294a90af09f2026-07-23WarningsExact identifier
application number: M017
DERMFREE WART CORN REMOVERSALICYLIC ACID 40% WART CORN REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a5c63b3-44de-8736-e063-6394a90ac21a2026-07-23WarningsExact identifier
application number: M017
DERMFREE Anti-itchHYDROCORTISONE1% ANTI-ITCHJiangxi Yudexi Pharmaceutical Co., LTD4a5af4c6-555a-e74c-e063-6394a90aa6ce2026-07-23WarningsExact identifier
application number: M017
DERMFREE HEMORRHOIDLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOIDJiangxi Yudexi Pharmaceutical Co., LTD4a5d0e79-d620-0147-e063-6294a90a31032026-07-23WarningsExact identifier
application number: M017
MAG 5 PT WARMING FORMULAMENTHOLRENU LABORATORIES, LLCa499ac9b-0e8e-e23f-e053-2a95a90abe9a2026-07-23WarningsExact identifier
application number: M017
Icy Hot Performance Cream Pain ReliefMENTHOL 16%, CAMPHOR 11%Chattem, Inc.73f7a113-ef11-4932-bf4d-4e62863f79412026-07-23WarningsExact identifier
application number: M017
Numbing Pain ReliefLIDOCAINE 4%Walgreen Company2425badb-e196-e9f8-e063-6294a90a7bf42026-07-22WarningsExact identifier
application number: M017
Cooling Pain ReliefMENTHOL 4.5%Walgreen Company24345ccf-c96f-31b0-e063-6294a90a82b52026-07-22WarningsExact identifier
application number: M017
Heat Pain ReliefCAPSAICIN 0.1%Walgreen Company2434f9cf-74aa-17af-e063-6294a90a56d92026-07-22WarningsExact identifier
application number: M017
Pain Relief Patch LidocaineLIDOCAINEHyVee41c26a66-3371-2c2c-e063-6294a90aa38b2026-07-22WarningsExact identifier
application number: M017
CVS Ultra Strength MuscleMENTHOL, CAMPHOR, METHYL SALICYLATECVS Pharmacy48bef8bc-6e39-a328-e063-6394a90ae4502026-07-22WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEAKRON PHARMA INCdaad9a1e-98d2-4ce7-9d97-ac5d81905abb2026-07-22WarningsExact identifier
application number: M017
Professional Therapy MuscleCare Pain RelievingMENTHOL, CAMPHORActive and Innovative573c2d85-9e0b-7955-e063-6394a90aff642026-07-22WarningsExact identifier
application number: M017
DOCTOR INK TOPICAL ANTISEPTIC WITH PAIN RELIEFBENZALKONIUM CHLORIDE, LIDOCAINEEnviro Specialty Chemicals Incf7abe66c-dc2d-4ef7-9b11-5b87157fd3022026-07-21WarningsExact identifier
application number: M017
Bclsks NUMBINGMENTHOL 1% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD49e26770-ddf6-7515-e063-6394a90a4ab32026-07-21WarningsExact identifier
application number: M017
Rstrvbr QUIT SMOKINGNICOTINE21MG QUIT SMOKINGJiangxi Yudexi Pharmaceutical Co., LTD4a5e9691-727f-6bcd-e063-6294a90aadfc2026-07-21WarningsExact identifier
application number: M017
Rstrvbr QUIT SMOKINGNICOTINE14MG QUIT SMOKINGJiangxi Yudexi Pharmaceutical Co., LTD4a5eec19-7f9a-d277-e063-6294a90ace952026-07-21WarningsExact identifier
application number: M017
Rstrvbr QUIT SMOKINGNICOTINE7MG QUIT SMOKINGJiangxi Yudexi Pharmaceutical Co., LTD4a5f124e-2dd7-16b8-e063-6294a90a5cdb2026-07-21WarningsExact 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