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 firm2026-10-20

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 4 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WALMART DAYTIME AND NIGHTTIME MS SEVERE RELIEF VALUE PACKACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCLWAL-MART STORES INC888bd90a-a059-4814-bd65-6b735ecfaf3a2026-08-31WarningsExact identifier
application number: M012
Severe Cold and Flu Daytime and NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLKroger49a98411-aa5a-6de3-e063-6294a90a148f2026-08-31WarningsExact identifier
application number: M012
equate daytime nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESEN, PHENYLEPHRINE HYDROCHLORIDESixarp, LLC5a5a6917-9fb5-e6ca-e063-6394a90af9dc2026-08-31WarningsExact identifier
application number: M012
Zicam Intense Sinus ReliefOXYMETAZOLINE HYDROCHLORIDEChurch & Dwight Co., Inc.d916f7ff-84b7-57ef-e053-2995a90a3efa2026-08-31WarningsExact identifier
application number: M012
Afrin Original NasalOXYMETAZOLINE HYDROCHLORIDEJC World Bell Wholesale Co., Inc.ecfa14b8-a3f3-4569-b489-c9e1a51cf09e2026-08-31WarningsExact identifier
application number: M012
Dextromethorphan HBrDEXTROMETHORPHAN HBRBIONPHARMA INC.5a5dde85-8785-8149-e063-6294a90a4d572026-08-31WarningsExact identifier
application number: M012
Equate NasalOXYMETAZOLINE HCLSixarp, LLC5a5e2458-bab0-4931-e063-6394a90ad6062026-08-31WarningsExact identifier
application number: M012
MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH RELIEFDEXTROMETHORPHAN HYDROBROMIDE AND HEXYLRESORCINOLReckitt Benckiser LLC8d670d91-9e22-45b9-b568-5b62c2133d322026-08-31WarningsExact identifier
application number: M012
Daytime Cold and Flu Multi Symptom ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLShield Pharmaceuticals Corpe85b4c2a-d4e0-452c-9a08-fcc0ff6eaa212026-08-31WarningsExact identifier
application number: M012
Daytime Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLShield Pharmaceuticals Corp67849e09-2056-4013-98b1-d003ed3250a22026-08-31WarningsExact identifier
application number: M012
MAX Tussin Mucus and Chest Congestion Sugar FreeGUAIFENESINAkron Pharma Inc.3b023b91-e703-4599-9864-96d8c328b45c2026-08-31WarningsExact identifier
application number: M012
MAX Tussin Mucus and Chest CongestionGUAIFENESINAkron Pharma Inc.ac874a31-5556-4669-937f-dcb52aaecd8a2026-08-31WarningsExact identifier
application number: M012
MAX Tussin Cough and Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINAkron Pharma Inc.e0ce4287-bfa1-4413-97c8-4fe2e39bda362026-08-31WarningsExact identifier
application number: M012
Acetaminophen PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLUnited Natural Foods, Inc. dba UNFI24173e77-92ec-4a87-a471-d6867837c1802026-08-31WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLDOLGENCORP, LLC69af44c2-390c-4223-889a-d5555aef57782026-08-28WarningsExact identifier
application number: M012
Tussin DM DaytimeDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED432d4833-2eaf-4f7c-b6b4-41043a6b7e2a2026-08-28WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLYour Military Exchanges13fcc43c-bdda-4b65-b6d7-23b39e6836512026-08-28Warnings, Adverse reactionsExact identifier
application number: M012
Multi-Symptom AllergyACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLWalgreen Company5170c450-989d-44fa-ab38-86c78feae3b62026-08-28WarningsExact identifier
application number: M012
Pain Reliever PM Extra strengthACETAMINOPHEN, DIPHENHYDRAMINE HCLWalgreens54cbbc5f-908b-47b2-b37f-3646354d35682026-08-27WarningsExact identifier
application number: M012
Maximum Strength Mucus ReliefDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLHyvee Inc4e578c7a-88d4-e4cd-e063-6394a90aac442026-08-27WarningsExact 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