FDA.reportPublic FDA data

Antiseptic Mouthrinse

Product NDC
49035-072
11-digit product format
490350072
Labeler code
49035
Product ID
49035-072_4bd2d520-4420-c426-e063-6294a90a181b
Type
HUMAN OTC DRUG
Nonproprietary name
Eucalyptol, Menthol, Methyl salicylate, Thymol
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Walmart Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1989-11-11
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
Antiseptic Mouthrinse
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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-072-12Antiseptic Mouthrinse1500 mL in 1 BOTTLE, PLASTICMOUTHWASH150020
49035-072-69Antiseptic Mouthrinse250 mL in 1 BOTTLE, PLASTICMOUTHWASH25020
49035-072-77Antiseptic Mouthrinse500 mL in 1 BOTTLE, PLASTICMOUTHWASH50020
49035-072-86Antiseptic Mouthrinse1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100020

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EUCALYPTOLACTIVE INGREDIENTRV6J6604TKANTISEPTIC MOUTHRINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WAL-MART STORES, INC.]4
MENTHOLACTIVE INGREDIENTL7T10EIP3AANTISEPTIC MOUTHRINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WAL-MART STORES, INC.]4
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YANTISEPTIC MOUTHRINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WAL-MART STORES, INC.]4
THYMOLACTIVE INGREDIENT3J50XA376EANTISEPTIC MOUTHRINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WAL-MART STORES, INC.]4
EUCALYPTOLACTIVE MOIETYRV6J6604TKANTISEPTIC MOUTHRINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WAL-MART STORES, INC.]4
MENTHOLACTIVE MOIETYL7T10EIP3AANTISEPTIC MOUTHRINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WAL-MART STORES, INC.]4
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZANTISEPTIC MOUTHRINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WAL-MART STORES, INC.]4
THYMOLACTIVE MOIETY3J50XA376EANTISEPTIC MOUTHRINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WAL-MART STORES, INC.]4
ALCOHOLINACTIVE INGREDIENT3K9958V90MANTISEPTIC MOUTHRINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WAL-MART STORES, INC.]4
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMANTISEPTIC MOUTHRINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WAL-MART STORES, INC.]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GANTISEPTIC MOUTHRINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WAL-MART STORES, INC.]4
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SANTISEPTIC MOUTHRINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WAL-MART STORES, INC.]4
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ANTISEPTIC MOUTHRINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WAL-MART STORES, INC.]4
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYANTISEPTIC MOUTHRINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WAL-MART STORES, INC.]4
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRANTISEPTIC MOUTHRINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WAL-MART STORES, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RANTISEPTIC MOUTHRINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WAL-MART STORES, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-072ANTISEPTIC MOUTHRINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WAL-MART STORES, INC.]19Current NDC, Legacy NDC, 4 package rows20250303_a8daefba-b985-4ef9-b900-e5647324662e.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 % MouthwashPSNa8daefba-b985-4ef9-b900-e5647324662e20
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCDa8daefba-b985-4ef9-b900-e5647324662e20
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSYa8daefba-b985-4ef9-b900-e5647324662e20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-072-12490350072121500 mL in 1 BOTTLE, PLASTIC (49035-072-12) 1500 ml1989-11-110000-00-00NoNoCurrent
49035-072-6949035007269.25 L in 1 BOTTLE, PLASTIC (49035-072-69) 1989-11-110000-00-00NoNoCurrent
49035-072-7749035007277500 mL in 1 BOTTLE, PLASTIC (49035-072-77) 500 ml1989-11-110000-00-00NoNoCurrent
49035-072-86490350072861 L in 1 BOTTLE, PLASTIC (49035-072-86) 1 l1989-11-110000-00-00NoNoCurrent