Antiseptic Mouth Rinse

Product NDC
36800-072
11-digit product format
368000072
Labeler code
36800
Product ID
36800-072_4ab7ce2e-b288-955d-e063-6294a90a3a44
Type
HUMAN OTC DRUG
Nonproprietary name
Eucalyptol, Menthol, Methyol salicylate, Thymol
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Topco Associates LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1995-07-07
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 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
a38e91c1-7ac6-4a7f-a5a2-8d9166b1535aAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-072-12Antiseptic Mouth Rinse1500 mL in 1 BOTTLE, PLASTICMOUTHWASH150015
36800-072-77Antiseptic Mouth Rinse500 mL in 1 BOTTLE, PLASTICMOUTHWASH50015
36800-072-86Antiseptic Mouth Rinse1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100015

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EUCALYPTOLACTIVE INGREDIENTRV6J6604TKANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]1
MENTHOLACTIVE INGREDIENTL7T10EIP3AANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]1
THYMOLACTIVE INGREDIENT3J50XA376EANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]1
EUCALYPTOLACTIVE MOIETYRV6J6604TKANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]1
MENTHOLACTIVE MOIETYL7T10EIP3AANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]1
METHYL SALICYLATEACTIVE MOIETYLAV5U5022YANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]1
THYMOLACTIVE MOIETY3J50XA376EANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-072ANTISEPTIC MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYOL SALICYLATE, THYMOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]14Current NDC, Legacy NDC, 3 package rows20250529_a38e91c1-7ac6-4a7f-a5a2-8d9166b1535a.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 107 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
pain relief roll-onLIDOCAINE 4%Bionpharma Inc.f607b6dc-8d13-604a-e053-2995a90a59ab2024-12-23WarningsExact identifier
application number: M017
Veneno de Abeja Aceite De Vibora BrandMETHYL SALICYLATEMiramar Cosmetics, Inc DBA Miramar Laba6c4889c-e7a9-44b9-bd9a-70fd6e8c48252024-12-23WarningsExact identifier
application number: M017
Itch ReliefHYDROCORTISONE 1%Trifecta Pharmaceuticals USA LLCaf5daf6c-bcad-8ebf-e053-2a95a90af1b02024-12-20WarningsExact identifier
application number: M017
Pain Itch ReliefLIDOCAINE HCITrifecta Pharmaceutical USA LLCf40b19a8-795c-f514-e053-2a95a90a6d152024-12-20WarningsExact identifier
application number: M017
Muscle Rub CreamMENTHOL 10%, METHYL SALICYLATE 15%Trifecta Pharmaceuticals USA, LLC.44d3638d-f29b-0e01-e054-00144ff88e882024-12-20WarningsExact identifier
application number: M017
Rhuli GelCAMPHOR, MENTHOLTrifecta Pharmaceuticals USA, LLC.4fbb3c23-ed47-336e-e054-00144ff8d46c2024-12-20WarningsExact identifier
application number: M017
Hydrocortisone Cream with AloeHYDROCORTISONERugby Laboratories132982ea-cce6-687c-e063-6294a90a46322024-12-20WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE 1%Pharmacy Value Alliance LLC9bb98452-a605-5c20-e053-2995a90a1ea72024-12-20WarningsExact identifier
application number: M017
DCH Cooling Pain ReliefMENTHOL 10.5%Derma Care Research Labs, LLC00dcdae0-c744-8402-e063-6294a90a12f82024-12-20WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE 1%Pharmacy Value Alliance LLCab95e606-69f0-1d58-e053-2a95a90a073b2024-12-20WarningsExact identifier
application number: M017
Itch Relief CreamZINC ACETATE 0.1%, DIPHENHYDRAMINE HYDROCHLORIDE 2%Pharmacy Value Alliance LLC37fe6d82-adee-4f58-e054-00144ff88e882024-12-20WarningsExact identifier
application number: M017
Warrior First Aid Anti ItchDIPHENHYDRAMINE HCL 2%, ZINC ACETATE 0.1%Derma Care Research Labs, LLCec6e9a5b-c61d-a385-e053-2995a90ac9362024-12-20WarningsExact identifier
application number: M017
DCH Burn ReliefLIDOCAINE HCLDerma Care Research Labs, LLCff227154-cf3b-9796-e053-6294a90a55352024-12-20WarningsExact identifier
application number: M017
Outback Pain ReliefCAMPHOR 6%, MENTHOL 16%Derma Care Research Labs, LLCc238c930-2012-2d48-e053-2a95a90a8a4a2024-12-20WarningsExact identifier
application number: M017
Meijer Pain ReliefLIDOCAINE HCL 4%Meijerf31b11ed-2ff9-5cfc-e053-2a95a90af2ca2024-12-20WarningsExact identifier
application number: M017
Meijer Pain ReliefMENTHOL 10.5%Meijerbed81975-bd63-cf5b-e053-2995a90ac5fa2024-12-20WarningsExact identifier
application number: M017
Mirakel Pain and Itch ReliefBENZOCAINE 20%, RESORCINOL 3%Sanvio, Inc.ed34d728-0275-e209-e053-2995a90a93ff2024-12-20WarningsExact identifier
application number: M017
Meijer Pain ReliefLIDOCAINE 4%Meijerbed67c31-c479-6f9b-e053-2a95a90a55162024-12-20WarningsExact identifier
application number: M017
Blue-Emu Ultra with Hemp SeedTROLAMINE SALICYLATEKingsway Pharmaceuticals dba NFI, LLC80a3cf99-16e8-412b-ab9f-3d9d5cbb7aa92024-12-20WarningsExact identifier
application number: M017
Epsom SaltsMAGNESIUM SULFATEInternational Wholesale Inc.e4d9bc32-ac85-349f-e053-2995a90a032f2024-12-19WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashPSNa38e91c1-7ac6-4a7f-a5a2-8d9166b1535a15
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCDa38e91c1-7ac6-4a7f-a5a2-8d9166b1535a15
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSYa38e91c1-7ac6-4a7f-a5a2-8d9166b1535a15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-072-12368000072121500 mL in 1 BOTTLE, PLASTIC (36800-072-12) 1500 ml1995-07-070000-00-00NoNoCurrent
36800-072-7736800007277500 mL in 1 BOTTLE, PLASTIC (36800-072-77) 500 ml1995-07-070000-00-00NoNoCurrent
36800-072-86368000072861000 mL in 1 BOTTLE, PLASTIC (36800-072-86) 1000 ml1995-07-070000-00-00NoNoCurrent