FDA.reportPublic FDA data

Tartar control plus

Product NDC
0363-0855
11-digit product format
003630855
Labeler code
0363
Product ID
0363-0855_4aa57877-df81-00f9-e063-6394a90af055
Type
HUMAN OTC DRUG
Nonproprietary name
Eucalyptol, menthol, methyl salicylate, thymol
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Walgreen Co.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-01-24
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
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
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
0363-0855-86Tartar control plus1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100015

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EUCALYPTOLACTIVE INGREDIENTRV6J6604TKTARTAR CONTROL PLUS (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WALGREEN CO]1
MENTHOLACTIVE INGREDIENTL7T10EIP3ATARTAR CONTROL PLUS (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WALGREEN CO]1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YTARTAR CONTROL PLUS (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WALGREEN CO]1
THYMOLACTIVE INGREDIENT3J50XA376ETARTAR CONTROL PLUS (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WALGREEN CO]1
EUCALYPTOLACTIVE MOIETYRV6J6604TKTARTAR CONTROL PLUS (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WALGREEN CO]1
MENTHOLACTIVE MOIETYL7T10EIP3ATARTAR CONTROL PLUS (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WALGREEN CO]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZTARTAR CONTROL PLUS (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WALGREEN CO]1
THYMOLACTIVE MOIETY3J50XA376ETARTAR CONTROL PLUS (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WALGREEN CO]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MTARTAR CONTROL PLUS (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WALGREEN CO]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMTARTAR CONTROL PLUS (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WALGREEN CO]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1STARTAR CONTROL PLUS (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WALGREEN CO]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2TARTAR CONTROL PLUS (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WALGREEN CO]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYTARTAR CONTROL PLUS (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WALGREEN CO]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUTARTAR CONTROL PLUS (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WALGREEN CO]1
SORBITOLINACTIVE INGREDIENT506T60A25RTARTAR CONTROL PLUS (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WALGREEN CO]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4TARTAR CONTROL PLUS (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WALGREEN CO]1
WATERINACTIVE INGREDIENT059QF0KO0RTARTAR CONTROL PLUS (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WALGREEN CO]1
ZINC CHLORIDEINACTIVE INGREDIENT86Q357L16BTARTAR CONTROL PLUS (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WALGREEN CO]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0855TARTAR CONTROL PLUS (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WALGREEN CO]14Current NDC, Legacy NDC, 1 package rows20250519_0780b123-a401-405b-9e50-6be818d71d39.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 % MouthwashPSN0780b123-a401-405b-9e50-6be818d71d3915
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD0780b123-a401-405b-9e50-6be818d71d3915
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY0780b123-a401-405b-9e50-6be818d71d3915

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0855-86003630855861000 mL in 1 BOTTLE, PLASTIC (0363-0855-86) 1000 ml2014-01-240000-00-00NoNoCurrent