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 54 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Burn Ease, 3.5gBURN EASE, 3.5GProStat First Aid LLC004aa18f-3a97-f454-e063-6394a90afcff2025-12-15WarningsExact identifier
application number: M017
PS-3866 Burn Ease, 0.9gPS-3866 BURN EASE, 0.9GProStat First Aid LLC004d00a5-9cff-29ff-e063-6294a90aeb8c2025-12-15WarningsExact identifier
application number: M017
First Aid Burn CreamFIRST AID BURN CREAMProStat First Aid LLC0037a1a4-d747-2567-e063-6394a90a721c2025-12-15WarningsExact identifier
application number: M017
PS-3885 Burn Ease, 3.5gPS-3885 BURN EASE, 3.5GProStat First Aid LLC004c6deb-2844-a0d0-e063-6394a90ae5e42025-12-15WarningsExact identifier
application number: M017
2677 First Aid Burn Cream2677 FIRST AID BURN CREAMProStat First Aid LLCff5bb628-8ef7-4540-e053-6394a90a55ed2025-12-15WarningsExact identifier
application number: M017
Burn EaseBURN EASEProStat First Aid LLCf71b98b4-22d0-0124-e053-6394a90ae4cf2025-12-15WarningsExact identifier
application number: M017
Burn EaseBURN EASEProStat First Aid LLCf71eb4f5-2280-5867-e053-6394a90aac572025-12-15WarningsExact identifier
application number: M017
Burn Ease 3.5gBURN EASE 3.5GFront Line Safety0f8e6842-c889-d5d3-e063-6394a90af8802025-12-15WarningsExact identifier
application number: M017
Burn Ease 3.5gBURN EASE 3.5GFront Line Safety0f8c59fb-3622-2bb7-e063-6294a90adc6e2025-12-15WarningsExact identifier
application number: M017
Burn EaseBURN EASEFront Line Safety0e34cb09-d8c6-f8c0-e063-6294a90a0be02025-12-15WarningsExact identifier
application number: M017
Burn Ease 3.5gBURN EASE 3.5GFront Line Safety0f52021f-af8a-5b95-e063-6294a90a2c2a2025-12-15WarningsExact identifier
application number: M017
Burn EaseBURN EASEProStat First Aid LLC0e25c936-e40a-e23c-e063-6294a90ac0e42025-12-15WarningsExact identifier
application number: M017
Sting Relief WipesSTING RELIEF WIPESProStat First Aid LLC0e20252a-5ecb-2526-e063-6294a90a8cde2025-12-15WarningsExact identifier
application number: M017
First Aid Burn CreamFIRST AID BURN CREAMFront Line Safety0f4ce2c2-f306-d95f-e063-6394a90ae7b32025-12-15WarningsExact identifier
application number: M017
Magsoothium BodyMENTHOL, CAPSAICINUbu/Elements, Inc.f604d30c-b17c-ec01-e053-2a95a90aa3042025-12-15WarningsExact identifier
application number: M017
Salonpas pain relieving JETMENTHOL, METHYL SALICYLATEHisamitsu Pharmaceutical Co., Inc.dd1ea3bf-891a-402e-8f43-14302bc9c3e52025-12-15WarningsExact identifier
application number: M017
Herbal Tendon Bone ReliefCAMPHOR MINTGuchutang Biotechnology (Longyan) Co., Ltd.45cf4040-9751-d24b-e063-6294a90aff272025-12-13WarningsExact identifier
application number: M017
ElixirLidoFastLIDOCAINE 5% CREAMELIXIR HEALTHCARE USA, LLC.45de5a3d-06c2-aa02-e063-6294a90a63d32025-12-13WarningsExact identifier
application number: M017
MEDI FIRST PLUSHYDROCORTISONE ACETATEOrazen Inc5781124a-60f4-4a64-80b7-ce5f28d495b52025-12-12WarningsExact identifier
application number: M017
MEDI-FIRSTHYDROCORTISONE ACETATEOrazen Incaeffd85c-58a7-4d64-bf94-977b6fbbe7132025-12-12WarningsExact 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