Antiseptic Mouth Rinse

Product NDC
50804-072
11-digit product format
508040072
Labeler code
50804
Product ID
50804-072_4b30ce9b-4174-edc0-e063-6394a90a11d8
Type
HUMAN OTC DRUG
Nonproprietary name
EUCALYPTOL
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Perrigo Direct, Inc�
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-08-15
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

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50804-072-69Antiseptic Mouth Rinse250 mL in 1 BOTTLE, PLASTICMOUTHWASH2509
50804-072-86Antiseptic Mouth Rinse1000 mL in 1 BOTTLE, PLASTICMOUTHWASH10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50804-072-86ML - Milliliter50804-0723fe3032f-f19e-473c-bcfd-04405221c2d912022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50804-072ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [PERRIGO DIRECT, INC.]7Current NDC, Legacy NDC, 2 package rows20250410_790843ce-88e2-4060-b61f-925fb30272da.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 % MouthwashPSN790843ce-88e2-4060-b61f-925fb30272da9
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD790843ce-88e2-4060-b61f-925fb30272da9
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY790843ce-88e2-4060-b61f-925fb30272da9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50804-072-6950804007269250 mL in 1 BOTTLE, PLASTIC (50804-072-69) 250 ml2009-08-150000-00-00NoNoCurrent
50804-072-86508040072861000 mL in 1 BOTTLE, PLASTIC (50804-072-86) 1000 ml2009-08-150000-00-00NoNoCurrent