FDA.reportPublic FDA data

Antiseptic Mouth Rinse

Product NDC
53942-318
Requested package NDC
53942-318-86
11-digit product format
539420318
Labeler code
53942
Product ID
53942-318_5c8d4386-0e9d-aa29-e063-6394a90ae67a
Type
HUMAN OTC DRUG
Nonproprietary name
Eucalyptol, Menthol, Methyl Salicylate, Thymol
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Demoulas Super Markets, Inc
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1990-07-15
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

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Antiseptic 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 UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
RV6J6604TKInternal UNII lookup
L7T10EIP3AInternal UNII lookup
LAV5U5022YInternal UNII lookup
3J50XA376EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1043619Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
37e9f40c-dff3-4185-abad-889e97ee4fcfAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53942-318-12Antiseptic Mouth Rinse1500 mL in 1 BOTTLE, PLASTICMOUTHWASH150019
53942-318-13Antiseptic Mouth Rinse1250 mL in 1 BOTTLE, PLASTICMOUTHWASH125019
53942-318-86Antiseptic Mouth Rinse1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100019

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EUCALYPTOLACTIVE INGREDIENTRV6J6604TKANTISEPTIC MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DEMOULAS SUPER MARKETS]3
MENTHOLACTIVE INGREDIENTL7T10EIP3AANTISEPTIC MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DEMOULAS SUPER MARKETS]3
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YANTISEPTIC MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DEMOULAS SUPER MARKETS]3
THYMOLACTIVE INGREDIENT3J50XA376EANTISEPTIC MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DEMOULAS SUPER MARKETS]3
EUCALYPTOLACTIVE MOIETYRV6J6604TKANTISEPTIC MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DEMOULAS SUPER MARKETS]3
MENTHOLACTIVE MOIETYL7T10EIP3AANTISEPTIC MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DEMOULAS SUPER MARKETS]3
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZANTISEPTIC MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DEMOULAS SUPER MARKETS]3
THYMOLACTIVE MOIETY3J50XA376EANTISEPTIC MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DEMOULAS SUPER MARKETS]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MANTISEPTIC MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DEMOULAS SUPER MARKETS]3
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMANTISEPTIC MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DEMOULAS SUPER MARKETS]3
CARAMELINACTIVE INGREDIENTT9D99G2B1RANTISEPTIC MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DEMOULAS SUPER MARKETS]3
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ANTISEPTIC MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DEMOULAS SUPER MARKETS]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUANTISEPTIC MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DEMOULAS SUPER MARKETS]3
WATERINACTIVE INGREDIENT059QF0KO0RANTISEPTIC MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DEMOULAS SUPER MARKETS]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53942-318ANTISEPTIC MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DEMOULAS SUPER MARKETS]18Current NDC, Legacy NDC, 3 package rows20250418_37e9f40c-dff3-4185-abad-889e97ee4fcf.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 % MouthwashPSN37e9f40c-dff3-4185-abad-889e97ee4fcf19
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD37e9f40c-dff3-4185-abad-889e97ee4fcf19
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY37e9f40c-dff3-4185-abad-889e97ee4fcf19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53942-318-86539420318861000 mL in 1 BOTTLE, PLASTIC (53942-318-86) 1000 ml1990-07-150000-00-00NoNoCurrent