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 76 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methyl SalicylateMETHYL SALICYLATEPHARMACURE LLC66b13044-69d2-4559-9e65-8a4c601c077a2025-10-06WarningsExact identifier
application number: M017
Methyl SalicylateMETHYL SALICYLATEPHARMACURE LLCf119a1bd-095f-41f5-86d5-c0ee4f19fd2c2025-10-06WarningsExact identifier
application number: M017
LIDOCAINELIDOCAINEPHARMACURE LLC31d5e5c9-6ec4-4496-8a4c-cca39a2cbe322025-10-06WarningsExact identifier
application number: M017
Tempo coolMENTHOLThe Egyptian Saudi Co. For Medical Manufacturing (Masco-Mid) S.A.Ebd642389-6d03-4e09-a71c-312fb90eae892025-10-06WarningsExact identifier
application number: M017
Menthopatch HotMENTHOL , CAPSICUM EXTRACTTHE EGYPTIAN SAUDI CO FOR MEDICAL MANUFACTURING MASCOMID3d289be3-c237-4065-a8ac-e8c2e51b76a52025-10-06WarningsExact identifier
application number: M017
Mentho patch coolMENTHOLTHE EGYPTIAN SAUDI CO FOR MEDICAL MANUFACTURING MASCOMID02251a4a-fc6f-42c9-a244-6f4835de5edd2025-10-06WarningsExact identifier
application number: M017
Feminine Anti-Itch CremeBENZOCAINE, RESORCINOLQuality Choice (CHAIN DRUG MARKETING ASSOCIATION)aa6cc963-dc60-5222-e053-2995a90acaf62025-10-06WarningsExact identifier
application number: M017
TheraCare 2% Diphenhydramine Anti-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEVeridian Healthcare5999b677-63dd-49c6-b5b8-7b3c117ecc5c2025-10-06WarningsExact identifier
application number: M017
HealthWise Pain ReliefMENTHOLVeridian Healthcare06be5331-7a1e-4ab3-9f17-2d350bd4b8902025-10-02WarningsExact identifier
application number: M017
equate Burn ReliefLIDOCAINE HYDROCHLORIDEWalmart Inca90cbd92-80a5-4463-8152-b83165121a6f2025-10-02WarningsExact identifier
application number: M017
AsperFlex HOTCAMPHOR, MENTHOL, METHYL SALICYLATEAkron Pharma Inc.a6cb0656-8866-44ff-b40c-73655ff687212025-10-02WarningsExact identifier
application number: M017
AsperFlex Original Maximum StrengthMENTHOLAkron Pharma Inc.d766c61e-c48b-4aff-97b0-678159479e032025-10-02WarningsExact identifier
application number: M017
HealthWise Feminine Anti-Itch CreamBENZOCAINE, RESORCINOLVeridian Healthcare1f9110da-f448-8e20-e063-6294a90a42752025-10-02WarningsExact identifier
application number: M017
PROSTAT FIRST AID Burn Ease, 0.9gLIDOCAINEProStat First Aid LLCdc704403-e2aa-47f7-a7f4-f6afe1547ca82025-10-01WarningsExact identifier
application number: M017
PROSTAT FIRST AID Burn Ease, 0.9gLIDOCAINEProStat First Aid LLCe02558a9-fe2b-4f28-9fd3-7308f859d7592025-10-01WarningsExact identifier
application number: M017
FL Burn Ease, 0.9gLIDOCAINEProStat First Aid LLC4dc0d579-ab42-4ea5-9788-5e54d7d318a32025-10-01WarningsExact identifier
application number: M017
Carmex Classic Lip Balm MedicatedCAMPHOR (SYNTHETIC), WHITE PETROLATUMCarma Laboratories, Inc.c7a7626c-cf82-4301-af79-c5e85367e7772025-10-01WarningsExact identifier
application number: M017
Viaderma Calm Anti-ItchHYDROCORTISONEViaDerma Distribution, Inc.7afa2ccd-bfc6-48fc-9a14-a0c6d645844e2025-10-01WarningsExact identifier
application number: M017
AsperFlex AdvanceCAMPHOR, MENTHOL, METHYL SALICYLATEAkron Pharma Inc.d23d7f2b-4dcd-4c31-9d12-340f233018b42025-10-01WarningsExact identifier
application number: M017
HEATING PAIN RELIEFMETHYL SALICYLATE, MENTHOLSUNSET NOVELTIES, INC4024d604-c8c7-2d73-e063-6294a90a2e802025-10-01WarningsExact 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