FDA.reportPublic FDA data

Tartar control plus

Product NDC
41163-855
11-digit product format
411630855
Labeler code
41163
Product ID
41163-855_4b09575a-6b32-833a-e063-6294a90a1c09
Type
HUMAN OTC DRUG
Nonproprietary name
Eucalyptol, menthol, methyl salicylate, thymol
Dosage form
MOUTHWASH
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-01-20
Substance
EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL
Active strength
.92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tartar control plus
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EUCALYPTOL.92 mg/mL
MENTHOL.42 mg/mL
METHYL SALICYLATE.6 mg/mL
THYMOL.64 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRV6J6604TK, L7T10EIP3A, LAV5U5022Y, 3J50XA376E
Rxcui1043619

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-855-12Tartar control plus1500 mL in 1 BOTTLE, PLASTICMOUTHWASH150015
41163-855-86Tartar control plus1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-855TARTAR CONTROL PLUS (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [UNITED NATURAL FOODS, INC. DBA UNFI]14Current NDC, Legacy NDC, 2 package rows20250330_263bed7e-b0fa-4a89-a4bd-4e6ae1e10687.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashPSN263bed7e-b0fa-4a89-a4bd-4e6ae1e1068715
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD263bed7e-b0fa-4a89-a4bd-4e6ae1e1068715
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY263bed7e-b0fa-4a89-a4bd-4e6ae1e1068715

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-855-12411630855121500 mL in 1 BOTTLE, PLASTIC (41163-855-12) 1500 ml2017-01-200000-00-00NoNoCurrent
41163-855-86411630855861000 mL in 1 BOTTLE, PLASTIC (41163-855-86) 1000 ml2017-01-200000-00-00NoNoCurrent