FDA.reportPublic FDA data

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 13 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr SabharwalsMETHYL SALICYLATE 10% GEL PATCHDr. Sabharwal's Wound Care4a7790bb-25cb-72b8-e063-6294a90a6b9c2026-06-29WarningsExact identifier
application number: M017
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYTarget Corporation36602b7a-99c0-f6a4-e063-6294a90a87582026-06-29WarningsExact identifier
application number: M017
FIRST SHIELDBENZALKONIUM CHLORIDE, LIDOCAINE HCIUnishieldf86f7446-b741-9f40-e053-6394a90a44222026-06-29WarningsExact identifier
application number: M017
MQ Lidocaine Pain Relief PatchLIDOCAINE PAIN RELIEF PATCHZhengzhou Miaoqi Medical Technology Co., Ltd.5560cdab-cee8-f6ec-e063-6294a90ad0242026-06-29WarningsExact identifier
application number: M017
GNP Lidocaine Maximum StrengthLIDOCAINE HCLAMERISOURCE BERGEN9f559c20-c9ac-e480-e053-2a95a90a8fce2026-06-29WarningsExact identifier
application number: M017
NUMBINGLIDOCAINEYIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED5553385d-c1e6-1242-e063-6394a90aa5a72026-06-28WarningsExact identifier
application number: M017
MOROVANLIDOCAINEHONG KONG UNORDERED TRADING CO., LIMITED550c8d2d-e0d7-1531-e063-6394a90a374d2026-06-25WarningsExact identifier
application number: M017
Marie Originals Medicated Outdoor Anti ItchHYDROCORTISONE SPRAYMarie's Original Formulas, LLC5517ee5f-1c51-cfd6-e063-6294a90af56f2026-06-25WarningsExact identifier
application number: M017
Marie Originals Medicated Outdoor Anti ItchHYDROCORTISONE SPRAYMarie's Original Formulas LLC55188ede-68cd-fcc6-e063-6394a90a5c582026-06-25WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONE CREAM 1%NuCare Pharmaceuticals, Inc.54f07a23-213f-ca46-e063-6394a90a00342026-06-24WarningsExact identifier
application number: M017
Terramed Just Think Comfort HerpCare EXTERNAL ANALGESIC FOR THE TEMPORARY RELIEF OF ITCHING AND IRRITATIONMENTHOL,PRAMOXINE HYDROCHLORIDERida LLCb62d09e4-7ced-49a9-8c83-3a8ef580f25a2026-06-23WarningsExact identifier
application number: M017
Terramed Just Think Comfort HerpCare Intimate Wash EXTERNAL ANALGESIC FOR THE TEMPORARY RELIEF OF ITCHING AND IRRITATIONPRAMOXINE HYDROCHLORIDERida LLC5b2cb1bd-2f1e-4670-b40e-6c058bfd12a22026-06-23WarningsExact identifier
application number: M017
Pain Relieving cleansing sparyBENZALKONIUM CHLORIDE AND LIDOCAINE HCITrifecta Pharmaceuticals USA, LLC.48edbb8d-0c35-91d8-e063-6394a90a71b82026-06-19WarningsExact identifier
application number: M017
Pain ReliefMENTHOLTrifecta Pharmaceuticals USA, LLC.493ab515-5cda-7b5a-e063-6294a90a295b2026-06-19WarningsExact identifier
application number: M017
Tiger Balm Muscle RubMETHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC)Haw Par Healthcare Ltd.011fc383-10bc-44cf-a67c-4be45fef33e02026-06-19WarningsExact identifier
application number: M017
CVS Health Scalp ReliefSALICYLIC ACIDCVS Health8de46015-817c-4cd9-95f8-293424f2a5c42026-06-19WarningsExact identifier
application number: M017
Careland Kinesiology Dual Action Pain Relieving TapeLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.67e0b3c5-e88e-4c48-a1e8-39f502ac249d2026-06-18WarningsExact identifier
application number: M017
ZensaLIDOCAINEAlera Skin Care Products Inc.549348ec-2eb2-3781-e063-6294a90a2f4a2026-06-18WarningsExact identifier
application number: M017
SprayPain AwayCAPSAICINProximity Capital Partners LLC dba Asutrac603e999-2316-496a-e053-2995a90ab4ed2026-06-17WarningsExact identifier
application number: M017
SprayPain Away LavenderCAPSAICINProximity Capital Partners LLC dba Asutra547e2167-ade0-ac7e-e063-6294a90a18ea2026-06-17WarningsExact 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