FDA.reportPublic FDA data

Mouth Rinse

Product NDC
55910-318
11-digit product format
559100318
Labeler code
55910
Product ID
55910-318_4c0f7ccc-21fb-c732-e063-6294a90aa9c4
Type
HUMAN OTC DRUG
Nonproprietary name
EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Old East Main Co.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2001-01-11
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
Mouth Rinse
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55910-318-122020-03-06C16284748780-19d75b9d1-2085-f424-e053-dadaa90a57ceRexall 318.003/318AH-AI Antiseptic Mouthrinse
55910-318-772020-03-06C16284748780-19d75b9d1-2085-f424-e053-dadaa90a57ceRexall 318.003/318AH-AI Antiseptic Mouthrinse
55910-318-122020-01-31C16284748780-19d75b9d1-2085-f424-e053-dadaa90a57ceRexall 318.003/318AH-AI Antiseptic Mouthrinse
55910-318-772020-01-31C16284748780-19d75b9d1-2085-f424-e053-dadaa90a57ceRexall 318.003/318AH-AI Antiseptic Mouthrinse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-318-12Mouth Rinse1500 mL in 1 BOTTLE, PLASTICMOUTHWASH150026
55910-318-77Mouth Rinse500 mL in 1 BOTTLE, PLASTICMOUTHWASH50026
55910-318-86Mouth Rinse1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100026

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EUCALYPTOLACTIVE INGREDIENTRV6J6604TKMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DOLGENCORP,LLC]2
MENTHOLACTIVE INGREDIENTL7T10EIP3AMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DOLGENCORP,LLC]2
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DOLGENCORP,LLC]2
THYMOLACTIVE INGREDIENT3J50XA376EMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DOLGENCORP,LLC]2
EUCALYPTOLACTIVE MOIETYRV6J6604TKMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DOLGENCORP,LLC]2
MENTHOLACTIVE MOIETYL7T10EIP3AMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DOLGENCORP,LLC]2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DOLGENCORP,LLC]2
THYMOLACTIVE MOIETY3J50XA376EMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DOLGENCORP,LLC]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DOLGENCORP,LLC]2
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DOLGENCORP,LLC]2
CARAMELINACTIVE INGREDIENTT9D99G2B1RMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DOLGENCORP,LLC]2
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DOLGENCORP,LLC]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DOLGENCORP,LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DOLGENCORP,LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-318MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [OLD EAST MAIN CO]25Current NDC, Legacy NDC, 3 package rows20250406_76554d61-ed96-4631-9140-135f1a2e282b.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 % MouthwashPSN76554d61-ed96-4631-9140-135f1a2e282b26
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD76554d61-ed96-4631-9140-135f1a2e282b26
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY76554d61-ed96-4631-9140-135f1a2e282b26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-318-12559100318121500 mL in 1 BOTTLE, PLASTIC (55910-318-12) 1500 ml2001-01-110000-00-00NoNoCurrent
55910-318-7755910031877500 mL in 1 BOTTLE, PLASTIC (55910-318-77) 500 ml2001-01-110000-00-00NoNoCurrent
55910-318-86559100318861000 mL in 1 BOTTLE, PLASTIC (55910-318-86) 1000 ml2001-01-110000-00-00NoNoCurrent