Mouthwash

Product NDC
71927-006
11-digit product format
719270006
Labeler code
71927
Product ID
71927-006_323a2253-01b0-de24-e063-6394a90ae0d7
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol, Methyl salicylate, Thymol
Dosage form
LIQUID
Route
ORAL
Labeler
Orazen Inc
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-04-22
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mouthwash
Listing expiration
2026-12-31

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
71927-006-012025-04-07C16284748780-12cef2736-7d13-d83d-e063-dadaa90ab31f71927-006
71927-006-012025-01-30C16284748780-12cef2736-7d13-d83d-e063-dadaa90ab31f71927-006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71927-006-01Mouthwash251 mL in 1 BOTTLELIQUID2512

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71927-006MOUTHWASH (MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [ORAZEN INC]2Current NDC, Legacy NDC, 1 package rows20250409_873c43df-1d46-359b-e053-2a91aa0a4319.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 % MouthwashPSN873c43df-1d46-359b-e053-2a91aa0a43192
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD873c43df-1d46-359b-e053-2a91aa0a43192
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY873c43df-1d46-359b-e053-2a91aa0a43192

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71927-006-0171927000601251 mL in 1 BOTTLE (71927-006-01) 251 ml2019-04-220000-00-00NoNoCurrent