Antiseptic Mouthrinse

Product NDC
72476-072
11-digit product format
724760072
Labeler code
72476
Product ID
72476-072_4ee26a82-1703-f0fb-e063-6394a90a91d1
Type
HUMAN OTC DRUG
Nonproprietary name
Eucalyptol, Menthol, Methyl salicylate, Thymol
Dosage form
MOUTHWASH
Route
ORAL
Labeler
ADUSA Distribution, LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-04-18
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 Mouthrinse
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
79b4969c-9cc8-4b51-8bf8-8dfcc412fb41Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72476-072-12Antiseptic Mouthrinse1500 mL in 1 BOTTLE, PLASTICMOUTHWASH15004
72476-072-69Antiseptic Mouthrinse250 mL in 1 BOTTLE, PLASTICMOUTHWASH2504
72476-072-77Antiseptic Mouthrinse500 mL in 1 BOTTLE, PLASTICMOUTHWASH5004
72476-072-86Antiseptic Mouthrinse1000 mL in 1 BOTTLE, PLASTICMOUTHWASH10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72476-072ANTISEPTIC MOUTHRINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [RETAIL BUSINESS SERVICES, LLC]2Current NDC, 4 package rows20250409_79b4969c-9cc8-4b51-8bf8-8dfcc412fb41.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antiseptic MouthrinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLADUSA Distribution, LLC79b4969c-9cc8-4b51-8bf8-8dfcc412fb412026-04-07Warnings, Adverse reactionsExact identifier
ndc (product): 72476-072

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashPSN79b4969c-9cc8-4b51-8bf8-8dfcc412fb414
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD79b4969c-9cc8-4b51-8bf8-8dfcc412fb414
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY79b4969c-9cc8-4b51-8bf8-8dfcc412fb414

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72476-072-12724760072121500 mL in 1 BOTTLE, PLASTIC (72476-072-12) 1500 ml2010-04-18NoNoCurrent
72476-072-6972476007269250 mL in 1 BOTTLE, PLASTIC (72476-072-69) 250 ml2010-04-18NoNoCurrent
72476-072-7772476007277500 mL in 1 BOTTLE, PLASTIC (72476-072-77) 500 ml2010-04-18NoNoCurrent
72476-072-86724760072861000 mL in 1 BOTTLE, PLASTIC (72476-072-86) 1000 ml2010-04-18NoNoCurrent