Original Antiseptic

Product NDC
72288-318
11-digit product format
722880318
Labeler code
72288
Product ID
72288-318_4c2091f5-d975-ff68-e063-6394a90a1153
Type
HUMAN OTC DRUG
Nonproprietary name
EUCALYPTOL, Menthol, Methyl salicylate, Thymol
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Amazon.com Services LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-05-01
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
Original Antiseptic
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
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72288-318-12Original Antiseptic1500 mL in 1 BOTTLE, PLASTICMOUTHWASH150014
72288-318-69Original Antiseptic250 mL in 1 BOTTLE, PLASTICMOUTHWASH25014
72288-318-77Original Antiseptic500 mL in 1 BOTTLE, PLASTICMOUTHWASH50014
72288-318-86Original Antiseptic1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-318ORIGINAL ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [AMAZON.COM SERVICES LLC]12Current NDC, Legacy NDC, 4 package rows20250519_11bfc79f-ffba-45f9-82b2-a7c19b990bb2.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 % MouthwashPSN11bfc79f-ffba-45f9-82b2-a7c19b990bb214
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD11bfc79f-ffba-45f9-82b2-a7c19b990bb214
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY11bfc79f-ffba-45f9-82b2-a7c19b990bb214

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72288-318-12722880318121500 mL in 1 BOTTLE, PLASTIC (72288-318-12) 1500 ml2018-05-010000-00-00NoNoCurrent
72288-318-6972288031869250 mL in 1 BOTTLE, PLASTIC (72288-318-69) 250 ml2018-05-010000-00-00NoNoCurrent
72288-318-7772288031877500 mL in 1 BOTTLE, PLASTIC (72288-318-77) 500 ml2018-05-010000-00-00NoNoCurrent
72288-318-86722880318861000 mL in 1 BOTTLE, PLASTIC (72288-318-86) 1000 ml2018-05-010000-00-00NoNoCurrent