FDA.reportPublic FDA data

ARTREX

Product NDC
68354-131
Requested package NDC
68354-131-60
11-digit product format
683540131
Labeler code
68354
Product ID
68354-131_3274fbeb-5bb7-fc45-e063-6294a90a0586
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor, Menthol, and Turpentine
Dosage form
CREAM
Route
TOPICAL
Labeler
Bioved Pharmaceuticals
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2004-04-01
Substance
CAMPHOR (NATURAL); MENTHOL; TURPENTINE
Active strength
3; 1.8; 6 g/60g; g/60g; g/60g
NDC exclude flag
No
Listing certified through
2026-12-31
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 packagepackage68354-13168354-131-60IInactivated by FDA2026-08-03

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
68354-131-102024-01-30Composition
68354-131-602024-01-30Composition
68354-131-102021-08-17Composition
68354-131-602021-08-17Composition
68354-131-102021-07-23Composition
68354-131-602021-07-23Composition

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68354-131-10ARTREX10 g in 1 TUBECREAM1018
68354-131-60ARTREX60 g in 1 TUBECREAM6018

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAMPHOR (NATURAL)ACTIVE INGREDIENTN20HL7Q941ARTREX (CAMPHOR, MENTHOL, AND TURPENTINE) CREAM [BIOVED PHARMACEUTICALS]3
MENTHOLACTIVE INGREDIENTL7T10EIP3AARTREX (CAMPHOR, MENTHOL, AND TURPENTINE) CREAM [BIOVED PHARMACEUTICALS]3
TURPENTINEACTIVE INGREDIENTXJ6RUH0O4GARTREX (CAMPHOR, MENTHOL, AND TURPENTINE) CREAM [BIOVED PHARMACEUTICALS]3
CAMPHOR (NATURAL)ACTIVE MOIETYN20HL7Q941ARTREX (CAMPHOR, MENTHOL, AND TURPENTINE) CREAM [BIOVED PHARMACEUTICALS]3
MENTHOLACTIVE MOIETYL7T10EIP3AARTREX (CAMPHOR, MENTHOL, AND TURPENTINE) CREAM [BIOVED PHARMACEUTICALS]3
TURPENTINEACTIVE MOIETYXJ6RUH0O4GARTREX (CAMPHOR, MENTHOL, AND TURPENTINE) CREAM [BIOVED PHARMACEUTICALS]3
CINNAMON OILINACTIVE INGREDIENTE5GY4I6YCZARTREX (CAMPHOR, MENTHOL, AND TURPENTINE) CREAM [BIOVED PHARMACEUTICALS]3
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI662ARTREX (CAMPHOR, MENTHOL, AND TURPENTINE) CREAM [BIOVED PHARMACEUTICALS]3
GINGER OILINACTIVE INGREDIENTSAS9Z1SVUKARTREX (CAMPHOR, MENTHOL, AND TURPENTINE) CREAM [BIOVED PHARMACEUTICALS]3
METHYL SALICYLATEINACTIVE INGREDIENTLAV5U5022YARTREX (CAMPHOR, MENTHOL, AND TURPENTINE) CREAM [BIOVED PHARMACEUTICALS]3
ROSE OILINACTIVE INGREDIENTWUB68Y35M7ARTREX (CAMPHOR, MENTHOL, AND TURPENTINE) CREAM [BIOVED PHARMACEUTICALS]3
THYMOLINACTIVE INGREDIENT3J50XA376EARTREX (CAMPHOR, MENTHOL, AND TURPENTINE) CREAM [BIOVED PHARMACEUTICALS]3
WEST INDIAN LEMONGRASS OILINACTIVE INGREDIENT5BIA40E9EDARTREX (CAMPHOR, MENTHOL, AND TURPENTINE) CREAM [BIOVED PHARMACEUTICALS]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68354-131ARTREX (CAMPHOR, MENTHOL, AND TURPENTINE) CREAM [BIOVED PHARMACEUTICALS]18Current NDC, Legacy NDC, 2 package rows20250412_f1c77900-b2c2-4c27-8ac8-e211b7d080ad.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 1 of 7 · 136 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EarBalance Ear Pain DropsLIDOCAINE HYDROCHLORIDE OTIC SOLUTIONMarie's Original Formulas LLC54dc3642-0b7a-07d8-e063-6294a90ad5562026-07-22WarningsExact identifier
application number: M014
EarBalance Ear Pain DropsLIDOCAINE HYDROCHLORIDE OTIC SOLUTIONMarie's Original Formulas LLC55057e1b-b11e-51b9-e063-6394a90a9fca2026-07-22WarningsExact identifier
application number: M014
Macks Dry n ClearEAR DRYING AIDMcKeon Products Inc1ea1da54-2412-c25c-e063-6294a90aa2642026-06-26WarningsExact identifier
application number: M014
Equate Swimmers Instant Ear DryEQUATE SWIMMERS INSTANT EAR DRYWalmart Stores, Inc76b58a7a-48cf-866c-e053-2a91aa0a7e632026-06-26WarningsExact identifier
application number: M014
Quality Choice Earwax Removal Drops Earwax Removal AidCARBAMIDE PEROXIDEChain Drug Marketing Association, Inc.c68b40d9-c1d4-4425-8063-50c00299e7182026-06-10WarningsExact identifier
application number: M014
Quality Choice Earwax Removal Kit Earwax Removal Aid and BulbCARBAMIDE PEROXIDEChain Drug Marketing Association, Inc.b2a641da-e070-4223-b836-5ca9ffb89f3f2026-06-10WarningsExact identifier
application number: M014
Freskaro Ear Drops for SwimmersFRESKARO EAR DROPS FOR SWIMMERSPharma Nobis, LLC4f724d85-cd38-41da-e063-6394a90a9fd72026-06-03WarningsExact identifier
application number: M014
Audiologists Choice Earwax Removal SystemCARBAMIDE PEROXIDEOaktree Products Inc.c9ad507b-341c-474f-aaa2-3c3a97a30dd82026-05-29WarningsExact identifier
application number: M014
CVS Health Earwax Removal KitCARBAMIDE PEROXIDECVS Pharmacy, Inc.f842534c-46dd-42c7-8386-9a03ce16da862026-05-29WarningsExact identifier
application number: M014
Lucid Hearing Earwax Removal Kit and BulbCARBAMIDE PEROXIDEHearing Lab Technology LLC5e09f566-397f-44d6-8ba2-90987765c7372026-05-29WarningsExact identifier
application number: M014
Good Neighbor Pharmacy Earwax Removal DropsCARBAMIDE PEROXIDEAmerisource Bergen89eac1b0-c700-45b5-8478-da53ace72e162026-05-29WarningsExact identifier
application number: M014
Good Neighbor Pharmacy Earwax RemovalCARBAMIDE PEROXIDEAmerisource Bergend503b10f-85cd-4bb8-9dec-82d651d525fa2026-05-29WarningsExact identifier
application number: M014
Meijer Earwax Removal KitCARBAMIDE PEROXIDEMeijer Distribution Inc.a5f7bd55-55c3-4b0e-a16c-33bbea40536a2026-05-29WarningsExact identifier
application number: M014
Quality Choice Earwax Removal DropsCARBAMIDE PEROXIDEChain Drug Marketing Association, Inc.d8fd8102-114f-415d-9083-f98a63f9d1b32026-05-29WarningsExact identifier
application number: M014
Menthol Pain Relieving GelPAIN RELIEVING GELNeilMed Pharmaceuticals Inc513a206c-bbf6-3e51-e063-6294a90adf7a2026-05-07WarningsExact identifier
application number: M014
ear dropsCARBAMIDE PEROXIDE 6.5%Bionpharma Inc.e8bcf92c-ad32-49d5-e053-2995a90ae0c62026-04-27WarningsExact identifier
application number: M014
Freskaro Earwax Removal AidCARBAMIDE PEROXIDE 6.50% KITPharma Nobis, LLC4f5967ee-bc05-341c-e063-6394a90a35c62026-04-15WarningsExact identifier
application number: M014
GoodSense Ear Wax Removal KitCARBAMIDE PEROXIDEPreferred Pharmaceuticals Inc.9a4198d2-cbea-466a-a252-d5c63d9ea0c12026-04-09WarningsExact identifier
application number: M014
Good Neighbor Pharmacy Earwax Removal DropsCARBAMIDE PEROXIDEPreferred Pharmaceuticals Inc.52f733a7-1301-4078-9267-5ce95b006ccc2026-04-09WarningsExact identifier
application number: M014
Walgreens Swimmers EarISOPROPYL ALCOHOLWalgreens Co3fb65a5c-c47f-ef2b-e063-6394a90af21a2026-04-01WarningsExact identifier
application number: M014

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1551280camphor 5 % / menthol 3 % / turpentine oil 10 % Topical CreamPSNf1c77900-b2c2-4c27-8ac8-e211b7d080ad18
1551280camphor 50 MG/ML / menthol 30 MG/ML / turpentine 100 MG/ML Topical CreamSCDf1c77900-b2c2-4c27-8ac8-e211b7d080ad18
1551280camphor 5 % / menthol 3 % / turpentine 10 % Topical CreamSYf1c77900-b2c2-4c27-8ac8-e211b7d080ad18
1551280camphor 5 % / menthol 3 % / turpentine oil 10 % Topical CreamSYf1c77900-b2c2-4c27-8ac8-e211b7d080ad18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68354-131-606835401316060 g in 1 TUBE (68354-131-60) 60 g2014-07-010000-00-00NoNoCurrent