FDA.reportPublic FDA data

Original Antiseptic

Product NDC
36800-318
11-digit product format
368000318
Labeler code
36800
Product ID
36800-318_4ab8b01d-aab7-692f-e063-6394a90a34d6
Type
HUMAN OTC DRUG
Nonproprietary name
EUCALYPTOL, Menthol, Methyl salicylate, Thymol
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Topco Associates LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1990-07-15
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
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
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-318-12Original Antiseptic1500 mL in 1 BOTTLE, PLASTICMOUTHWASH150015
36800-318-69Original Antiseptic250 mL in 1 BOTTLE, PLASTICMOUTHWASH25015
36800-318-86Original Antiseptic1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100015

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EUCALYPTOLACTIVE INGREDIENTRV6J6604TKORIGINAL ANTISEPTIC (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]1
MENTHOLACTIVE INGREDIENTL7T10EIP3AORIGINAL ANTISEPTIC (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YORIGINAL ANTISEPTIC (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]1
THYMOLACTIVE INGREDIENT3J50XA376EORIGINAL ANTISEPTIC (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]1
EUCALYPTOLACTIVE MOIETYRV6J6604TKORIGINAL ANTISEPTIC (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]1
MENTHOLACTIVE MOIETYL7T10EIP3AORIGINAL ANTISEPTIC (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]1
METHYL SALICYLATEACTIVE MOIETYLAV5U5022YORIGINAL ANTISEPTIC (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]1
THYMOLACTIVE MOIETY3J50XA376EORIGINAL ANTISEPTIC (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MORIGINAL ANTISEPTIC (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMORIGINAL ANTISEPTIC (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]1
CARAMELINACTIVE INGREDIENTT9D99G2B1RORIGINAL ANTISEPTIC (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ORIGINAL ANTISEPTIC (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RORIGINAL ANTISEPTIC (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-318ORIGINAL ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]14Current NDC, Legacy NDC, 3 package rows20250529_b6c8d5b1-4b19-463c-826a-cccdcec09e2d.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 % MouthwashPSNb6c8d5b1-4b19-463c-826a-cccdcec09e2d15
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCDb6c8d5b1-4b19-463c-826a-cccdcec09e2d15
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSYb6c8d5b1-4b19-463c-826a-cccdcec09e2d15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-318-12368000318121500 mL in 1 BOTTLE, PLASTIC (36800-318-12) 1500 ml1990-07-150000-00-00NoNoCurrent
36800-318-6936800031869250 mL in 1 BOTTLE, PLASTIC (36800-318-69) 250 ml1990-07-150000-00-00NoNoCurrent
36800-318-86368000318861000 mL in 1 BOTTLE, PLASTIC (36800-318-86) 1000 ml1990-07-150000-00-00NoNoCurrent