FDA.reportPublic FDA data

ARTREX

Product NDC
68354-131
Requested package NDC
68354-131-10
11-digit product format
683540131
Labeler code
68354
Product ID
68354-131_c9ef18bf-50b6-ea88-e053-2a95a90a951f
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor, Menthol, and Turpentine
Dosage form
CREAM
Route
TOPICAL
Labeler
Bioved Pharmaceuticals
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2004-04-01
Marketing end
0000-00-00
Substance
CAMPHOR (NATURAL); MENTHOL; TURPENTINE
Active strength
3 g/60g; g/60g; g/60g
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage68354-13168354-131-10IInactivated by FDA2026-09-14

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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]18Legacy NDC, 2 package rows20250412_f1c77900-b2c2-4c27-8ac8-e211b7d080ad.zip

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
68354-131-106835401311010 g in 1 TUBE (68354-131-10) 10 g2017-08-020000-00-00YesNoCurrent