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 firm2026-10-16

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 2 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vicks childrens Cough CongestionPHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESINThe Procter & Gamble Manufacturing Companye2356457-9791-3710-e053-2995a90ad1402026-09-08WarningsExact identifier
application number: M012
Cold Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWal-Mart Stores Inc077fac1a-0ec5-40d9-8861-a281b48f650a2026-09-08WarningsExact identifier
application number: M012
Overnight Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLRARITAN PHARMACEUTICALSeef00453-9f4f-4a05-bb4e-49b94705b52c2026-09-08WarningsExact identifier
application number: M012
Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINERARITAN PHARMACEUTICALS INC9819155b-2713-42be-867e-16605e7643d02026-09-08WarningsExact identifier
application number: M012
Cold and Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATEWALMART INC.f9d1dfd1-527f-491d-9188-14886ac70ced2026-09-08WarningsExact identifier
application number: M012
severe cold and cough daytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDERARITAN PHARMACEUTICALS INC3ce8508e-7d9d-4413-858a-8f952e760c012026-09-08WarningsExact identifier
application number: M012
Multi Symptom Severe ColdACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLRARITAN PHARMACEUTICALS INCd9606c9a-31b1-4121-9870-809a05f5b68a2026-09-08WarningsExact identifier
application number: M012
Mucus Relief DM Honey and Berry FlavorDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINRARITAN PHARMACEUTICALS INC4898b1c2-55ef-4589-982b-2279c01707e52026-09-08WarningsExact identifier
application number: M012
Mucus Relief Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLChain Drug Marketing Association, Inc.2a7afe03-3c34-4e30-827e-b3bb2568cb972026-09-08WarningsExact identifier
application number: M012
Drx Choice childrens allergy chewsDIPHENHYDRAMINE HCLRARITAN PHARMACEUTICALS INCdd2be906-bd0a-437c-9693-54b9391a5da32026-09-05WarningsExact identifier
application number: M012
Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.49235f4f-e661-4a83-88ef-b9a9568487772026-09-04WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDERite Aid Corporation71845bf9-8981-4ca0-a62c-dbef102b1b022026-09-04WarningsExact identifier
application number: M012
NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEAmazon.com Services LLC774d2bde-9f57-4ced-800a-cada39c685ed2026-09-04WarningsExact identifier
application number: M012
NostrillaOXYMETAZOLINE HYDROCHLORIDEInsight Pharmaceuticals LLC86217847-8e2b-48cc-b289-4987fd3aa7c32026-09-04WarningsExact identifier
application number: M012
tussin cough chest congestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINRite Aid Corporation86fc3723-5fc5-4de5-bd04-7774c2abe5392026-09-04WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRTopco Associates, LLCed576bf1-3949-423e-af2e-e4b1a3839b212026-09-04WarningsExact identifier
application number: M012
tussin nighttime coughDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATERite Aid Corporation80d51af8-3a7b-4d22-8d4f-df5f919130472026-09-04WarningsExact identifier
application number: M012
NO MORE NOSEBLEEDOXYMETAZOLINE HYDROCHLORIDEDR. FRIEDMAN'S NO MORE NOSEBLEED KIT INC.69d3f1fe-b476-4f84-8c5e-94957b74b46c2026-09-04WarningsExact identifier
application number: M012
Ultra Fine Mist Sinus ReliefOXYMETAZOLINE HYDROCHLORIDEDOLGENCORP, INC.5f134840-2465-4585-a85d-08d746f76f7a2026-09-03WarningsExact identifier
application number: M012
Daytime Nighttime Severe Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCI DOXYLAMINE SUCINATEFamily Dollar (FAMILY WELLNESS)22918db6-9096-4eb8-a742-aaa2dd5c31da2026-09-03WarningsExact 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