Antiseptic Mouth Rinse

Product NDC
37808-318
11-digit product format
378080318
Labeler code
37808
Product ID
37808-318_4a9014de-51a1-319c-e063-6394a90a4632
Type
HUMAN OTC DRUG
Nonproprietary name
Eucalyptol, Menthol, Methyl salicylate, Thymol
Dosage form
MOUTHWASH
Route
ORAL
Labeler
H E B
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-05-21
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 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-318-12Antiseptic Mouth Rinse1500 mL in 1 BOTTLE, PLASTICMOUTHWASH150016
37808-318-77Antiseptic Mouth Rinse500 mL in 1 BOTTLE, PLASTICMOUTHWASH50016
37808-318-86Antiseptic Mouth Rinse1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-318ANTISEPTIC MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [HEB]15Current NDC, Legacy NDC, 3 package rows20250417_8ba4382d-1a88-4a8d-9d40-c0f38cfd01a5.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 % MouthwashPSN8ba4382d-1a88-4a8d-9d40-c0f38cfd01a516
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD8ba4382d-1a88-4a8d-9d40-c0f38cfd01a516
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY8ba4382d-1a88-4a8d-9d40-c0f38cfd01a516

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-318-12378080318121500 mL in 1 BOTTLE, PLASTIC (37808-318-12) 1500 ml2009-05-21NoNoHistorical
37808-318-7737808031877500 mL in 1 BOTTLE, PLASTIC (37808-318-77) 500 ml2009-05-210000-00-00NoNoCurrent
37808-318-86378080318861000 mL in 1 BOTTLE, PLASTIC (37808-318-86) 1000 ml2009-05-210000-00-00NoNoCurrent