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 47 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NUVALU ICE THERAPY MENTHOL PAIN RELIEVINGMENTHOLJC SALES490bc3b1-48bf-5437-e063-6394a90a90182026-01-01WarningsExact identifier
application number: M017
NUVALU ICE THERAPY MENTHOL PAIN RELIEVINGMENTHOLNINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.5ae00308-0a8c-065c-e063-6394a90aff6b2026-01-01WarningsExact identifier
application number: M017
NUVALU ICE THERAPY MENTHOL PAIN RELIEVINGMENTHOLNINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.4a24e813-6dbc-3fd1-e063-6294a90a4ff02026-01-01WarningsExact identifier
application number: M017
Lidozen PatchLIDOCAINE, MENTHOLVillage Pharma LLCd0ec7d25-ad58-46f2-b3b3-f13b4648b0b62026-01-01WarningsExact identifier
application number: M017
FEMININE PAIN RELIEFMENTHOL, UNSPECIFIED FORMBeYou Together Ltd9636b973-fe7e-481e-a6e9-8070347c08832025-12-31WarningsExact identifier
application number: M017
Itch ReliefDIPHENHYDRAMINE HCLFSA Store Inc.47434af6-0fdd-9615-e063-6394a90ab9e82025-12-31WarningsExact identifier
application number: M017
Winco Lidocaine Pain Patch 4% 5ctLIDOCAINE PAIN PATCH 4%WINCO FOODS, LLC47439162-fc34-f0d0-e063-6394a90a29ab2025-12-31WarningsExact identifier
application number: M017
Pain Relief PatchPAIN RELIEF PATCHQUEST USA CORP.1ad47834-4f8e-c692-e063-6294a90a7e772025-12-31WarningsExact identifier
application number: M017
DermagesicPRAMOXINE HCL, ZINC OXIDE, CALAMINELlorens Pharmaceutical International Divisionbbff6b53-29da-45c1-8ccd-3e9df7f250e02025-12-31WarningsExact identifier
application number: M017
Dologesic Roll-OnLIDOCAINE HCLLlorens Pharmaceutical International Division, Inc.81546810-85a8-45fe-b9e6-cdd02cc4c0802025-12-31WarningsExact identifier
application number: M017
Mentholatum Soothing Vapor Rub LavenderCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Mentholatum Company47473b24-a3e3-2858-e063-6394a90a59202025-12-31WarningsExact identifier
application number: M017
Eucerin Itch Relief Intensive CalmingMENTHOLBeiersdorf Inca7a78af1-1f5a-684d-e053-2a95a90a6ae92025-12-31WarningsExact identifier
application number: M017
Eucerin Skin Calming Itch Relief TreatmentMENTHOLBeiersdorf Inc7e568311-1e6b-9b4b-e053-2991aa0a7b672025-12-31WarningsExact identifier
application number: M017
Steady FreddyLIDOCAINEMedical Symbiosis Pty Ltdcaa9eae9-7028-5185-e053-2a95a90ac5042025-12-31WarningsExact identifier
application number: M017
HYDROCORTISONEANTI-ITCH CREAMWater-Jel Technologies3d34ae31-265a-46bc-a52d-546ea5bb24b62025-12-31WarningsExact identifier
application number: M017
Antibacterial Lidocaine Wound GelBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEWater-Jel Technologies, LLCef1a6100-7f78-1fdb-e053-2a95a90abf202025-12-31WarningsExact identifier
application number: M017
Kroger Pain Relief Lidocaine PatchLIDOCAINEKroger Companyf6407554-c9a7-24e2-e053-2a95a90aae022025-12-30WarningsExact identifier
application number: M017
Kroger Hot and Cold Medicated PatchMENTHOLKroger Company0331c1dd-fe30-421a-85a7-6c6886e7ab272025-12-30WarningsExact identifier
application number: M017
Menthol, CamphorMENTHOL, CAMPHORChemco Corporation472fb097-92e5-c230-e063-6294a90ab33a2025-12-30WarningsExact identifier
application number: M017
MENTHOLMENTHOLCHEMCO CORPORATIOM472fb99c-dcc2-d9a9-e063-6294a90a794c2025-12-30WarningsExact 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