FDA.reportPublic FDA data

Eucamint

Product NDC
10578-001
11-digit product format
105780001
Labeler code
10578
Product ID
10578-001_586256ec-2a26-89a5-e063-6394a90a40df
Type
HUMAN OTC DRUG
Nonproprietary name
menthol, camphor
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Indiana Botanic Gardens
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1995-01-01
Substance
MENTHOL; CAMPHOR (SYNTHETIC)
Active strength
2.61; 4.35 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage10578-00110578-001-04DDiscontinued by firm2026-10-21

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
Eucamint
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL2.61 g/100g
CAMPHOR (SYNTHETIC)4.35 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
5TJD82A1ETInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1663849Internal RxNorm lookup
1663854Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d79bc8de-9efb-4996-a55c-accda0f8edb2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10578-001-02Eucamint57 g in 1 JAROINTMENT574
10578-001-04Eucamint114 g in 1 JAROINTMENT1144

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ETEUCAMINT (MENTHOL, CAMPHOR) OINTMENT [INDIANA BOTANIC GARDENS]1
MENTHOLACTIVE INGREDIENTL7T10EIP3AEUCAMINT (MENTHOL, CAMPHOR) OINTMENT [INDIANA BOTANIC GARDENS]1
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ETEUCAMINT (MENTHOL, CAMPHOR) OINTMENT [INDIANA BOTANIC GARDENS]1
MENTHOLACTIVE MOIETYL7T10EIP3AEUCAMINT (MENTHOL, CAMPHOR) OINTMENT [INDIANA BOTANIC GARDENS]1
CITRONELLA OILINACTIVE INGREDIENTQYO8Q067D0EUCAMINT (MENTHOL, CAMPHOR) OINTMENT [INDIANA BOTANIC GARDENS]1
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI662EUCAMINT (MENTHOL, CAMPHOR) OINTMENT [INDIANA BOTANIC GARDENS]1
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHEUCAMINT (MENTHOL, CAMPHOR) OINTMENT [INDIANA BOTANIC GARDENS]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UEUCAMINT (MENTHOL, CAMPHOR) OINTMENT [INDIANA BOTANIC GARDENS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10578-001EUCAMINT (MENTHOL, CAMPHOR) OINTMENT [INDIANA BOTANIC GARDENS]4Current NDC, Legacy NDC, 2 package rows20241215_d79bc8de-9efb-4996-a55c-accda0f8edb2.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 8 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Health No DripNASAL MISTCVS PHARMACY,INC.60ee7bd2-0d7c-4228-a559-0d5dbd3d44fa2026-08-17WarningsExact identifier
application number: M012
Daytime Cold and Cough and NightTime Cold and Congestion ChildrensBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWalgreens2bdc62b6-f3e1-4a79-9b29-00cc1d4280b32026-08-17WarningsExact identifier
application number: M012
CVS Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLCVS HEALTHf01ab8ef-d29a-4e33-8a14-4c57ccdcc0d62026-08-17WarningsExact identifier
application number: M012
Daytime NighttimeACETAMINOPHEN, GUAIFENESIN, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLKROGER COMPANY30d50bbe-0a14-c985-e063-6294a90a47b32026-08-16WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEARMY AND AIR FORCE EXCHANGE SERVICE77f87e19-a9d5-479d-9434-bbde13210bfb2026-08-15WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECardinal Health 110, LLC. DBA Leaderb1c2055b-4b5a-4fa2-b600-8930c9c8524c2026-08-15WarningsExact identifier
application number: M012
Nighttime HBP Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS PHARMACY146c9a62-0418-4b5d-9074-5be8a05f3f932026-08-15WarningsExact identifier
application number: M012
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leader610accad-2f8b-4605-9357-a58e6e18d4172026-08-15WarningsExact identifier
application number: M012
Nasal Decongestant Maximum Strength, Non-DrowsyPSEUDOEPHEDRINE HCLAmerisource Bergen1fdb1ba5-4072-4baf-9e30-f01d57bf6d822026-08-15WarningsExact identifier
application number: M012
Cold and Flu NightACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWalgreen Company32c67914-d7cf-40ee-8682-0ba8ed6912872026-08-15WarningsExact identifier
application number: M012
CVS Childrens COLD PLUS COUGH PLUS SORE THROATACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDECVS PHARMACY27820bce-6638-4f17-ac66-62b02b76bec32026-08-14WarningsExact identifier
application number: M012
CVS PHARMACY Childrens Cold and AllergyBROMPHENIRAMINE MALEATECVS PHARMACY, INC.004e104b-d6ff-48d5-8685-cd1bff45399a2026-08-14WarningsExact identifier
application number: M012
CHILDRENS DIMETAPP COLD AND COUGHBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS PHARMACY7babf4f6-ca0a-44a7-b1ea-d60e20d36f152026-08-14WarningsExact identifier
application number: M012
NasalOXYMETAZOLINE HYDROCHLORIDEAmazon.com Services LLCe7c8ffed-83b8-4088-b72c-d937e93f8b542026-08-14WarningsExact identifier
application number: M012
CVS Mucus Relief DM and Overnight Cold and FluDEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN AND TRIPROLIDINE HCLCVS75520b77-d40b-4f43-b92a-7a3eba5b493f2026-08-14WarningsExact identifier
application number: M012
CVS Severe Multi-Symptom Cough Cold FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS PHARMACYbb24c298-1d00-4378-8de3-b4056220fa752026-08-14WarningsExact identifier
application number: M012
SEVERE COLD PLUS FLU DAYTIME NIGHTTIMEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATECVS Pharmacy,Inc.6cb1d08b-e544-4084-b9ed-1e0d99a709c82026-08-14Warnings, Adverse reactionsExact identifier
application number: M012
Theraflu Relief Max Strength DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS PHARMACY932a3d40-9b52-4e91-bc61-6fd506f2d9e62026-08-14WarningsExact identifier
application number: M012
Multi Symptom Severe Cold and Nighttime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLCVS Pharmacy,Inc.91063edd-1e7e-41e9-8412-b14ef37490182026-08-14WarningsExact identifier
application number: M012
CVS Childrens Cold and AllergyBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLCVS PHARMACY, INC.f4020c08-29f6-4609-834e-191ce68851302026-08-14WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1663849Camphor 4.35 % / Menthol 2.61 % Topical OintmentPSNd79bc8de-9efb-4996-a55c-accda0f8edb24
1663854Eucamint 4.35 % / 2.61 % Topical OintmentPSNd79bc8de-9efb-4996-a55c-accda0f8edb24
1663854camphor 0.0435 MG/MG / menthol 0.0261 MG/MG Topical Ointment [Eucamint]SBDd79bc8de-9efb-4996-a55c-accda0f8edb24
1663849camphor 0.0435 MG/MG / menthol 0.0261 MG/MG Topical OintmentSCDd79bc8de-9efb-4996-a55c-accda0f8edb24
1663849Camphor 4.35 % / Menthol 2.61 % Topical OintmentSYd79bc8de-9efb-4996-a55c-accda0f8edb24
1663854Eucamint 4.35 % / 2.61 % Topical OintmentSYd79bc8de-9efb-4996-a55c-accda0f8edb24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10578-001-021057800010257 g in 1 JAR (10578-001-02) 57 g1995-01-010000-00-00NoNoCurrent
10578-001-0410578000104114 g in 1 JAR (10578-001-04) 114 g1995-01-010000-00-00NoNoCurrent