Home NDC 36800-072 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 Ingredient Strength 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.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1043619 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 36800-072-12 Antiseptic Mouth Rinse 1500 mL in 1 BOTTLE, PLASTIC MOUTHWASH 1500 15 36800-072-77 Antiseptic Mouth Rinse 500 mL in 1 BOTTLE, PLASTIC MOUTHWASH 500 15 36800-072-86 Antiseptic Mouth Rinse 1000 mL in 1 BOTTLE, PLASTIC MOUTHWASH 1000 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded EUCALYPTOL ACTIVE INGREDIENT RV6J6604TK ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC] 1 MENTHOL ACTIVE INGREDIENT L7T10EIP3A ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC] 1 METHYL SALICYLATE ACTIVE INGREDIENT LAV5U5022Y ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC] 1 THYMOL ACTIVE INGREDIENT 3J50XA376E ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC] 1 EUCALYPTOL ACTIVE MOIETY RV6J6604TK ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC] 1 MENTHOL ACTIVE MOIETY L7T10EIP3A ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC] 1 METHYL SALICYLATE ACTIVE MOIETY LAV5U5022Y ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC] 1 THYMOL ACTIVE MOIETY 3J50XA376E ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC] 1 BENZOIC ACID INACTIVE INGREDIENT 8SKN0B0MIM ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC] 1 FD&C GREEN NO. 3 INACTIVE INGREDIENT 3P3ONR6O1S ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC] 1 POLOXAMER 407 INACTIVE INGREDIENT TUF2IVW3M2 ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-072 ANTISEPTIC MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYOL SALICYLATE, THYMOL) MOUTHWASH [TOPCO ASSOCIATES, LLC] 14 Current NDC, Legacy NDC, 3 package rows 20250529_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 129 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Itch and Rash Cream HYDROCORTISONE Wildman Business Group 1f95757d-a434-f02a-e063-6294a90a2d12 2024-09-01 Warnings Exact identifier application number: M017 Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Wildman Business Group 1fd1a4b3-b6fd-0d4c-e063-6394a90a3680 2024-09-01 Warnings Exact identifier application number: M017 Thera Care Cold Hot Medicated Patch MENTHOL Veridian Healthcare b1ce129d-06a1-7755-e053-2995a90abd7d 2024-08-29 Warnings Exact identifier application number: M017 BIOSAVIA External Analgesic Pain Relief CAPSAICIN BIOSAVIA USA, LLC 814aa66b-7719-4a29-a84e-18290367e9c7 2024-08-28 Warnings Exact identifier application number: M017 Careland Plantar Fasciitis Hydrogel Pain Patches LIDOCAINE, MENTHOL Planet (Anhui) Pharmaceutical Co., Ltd. 0e2f29c2-2e95-4be0-b7e9-f1761a1321a5 2024-08-21 Warnings Exact identifier application number: M017 Careland Max Strength Lidocaine 4 Pain Relieving LIDOCAINE Planet (Anhui) Pharmaceutical Co., Ltd. 265b8dd7-64a4-4bc2-a91c-26c761c2090b 2024-08-21 Warnings Exact identifier application number: M017 Real Time Pain Relief Maxx Topical Analgesic MENTHOL REAL TIME PRODUCTS, INC f45eb95a-2813-4124-bdb0-54e078a8237d 2024-08-20 Warnings Exact identifier application number: M017 Theracare Lidocaine Pain relief LIDOCAINE Veridian Healthcare 1d8a3679-637d-94c0-e063-6294a90a9ecf 2024-08-19 Warnings Exact identifier application number: M017 LidoSync LIDOCAINE, MENTHOL iON Pharma, LLC 200f883c-439a-3b99-e063-6394a90aed10 2024-08-19 Warnings Exact identifier application number: M017 Eagle Brand Medicated Oil Refresh CAMPHOR, MENTHOL Borden Company (Private) Limited 09243a23-1f17-f77b-e063-6394a90a0b22 2024-08-19 Warnings Exact identifier application number: M017 CVS Health Maximum Strength Scalp Relief Anti-itch HYDROCORTISONE CVS Health b5ef0005-8b76-4205-8be0-db3a7ed7d1c4 2024-08-19 Warnings Exact identifier application number: M017 Rite Aid Pain Relieving Roll-On LIDOCAINE HCL Rite Aid Corporation 1406590c-667c-84eb-e063-6294a90a5052 2024-08-16 Warnings Exact identifier application number: M017 Nuvira CAPSAICIN 0.025%, MENTHOL 10%, METHYL NICOTINATE 0.25%, METHYL SALICYLATE 10% Strand Health Group ff448183-03cf-df2d-e053-6394a90a77f0 2024-08-16 Warnings Exact identifier application number: M017 FLANAX METHYL SALICYLATE, MENTHOL, CAPSAICIN Belmora LLC 5e06c688-a086-4c1c-8dab-fcead61fef40 2024-08-13 Warnings Exact identifier application number: M017 Pain Relief MENTHOL Pain Relieving Spray Inc. 1f44466f-044f-70fe-e063-6294a90ad575 2024-08-09 Warnings Exact identifier application number: M017 Meijer Cold Therapy Pain Relieving MENTHOL Meijer Inc 1c5b55e3-f859-71b6-e063-6294a90a633b 2024-08-08 Warnings Exact identifier application number: M017 HealthWise Soothing Cold Therapy Gel MENTHOL 4% Veridian Healthcare 1f09ccdd-09d8-6a8d-e063-6394a90a184f 2024-08-08 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE Nantong Health & Beyond Hygienic Products Inc. fbbbcc67-b46d-d41a-e053-6294a90aa55d 2024-08-08 Warnings Exact identifier application number: M017 Cheezheng Pain Relief Cream MENTHOL Tibet Cheezheng Tibetan Medicine Co. Ltd 37279a3f-9207-4e4c-90d6-52735044f104 2024-08-07 Warnings Exact identifier application number: M017 CVS Health Hydrocortisone Anti Itch HYDROCORTISONE CVS Health 546a1b8a-8254-432a-85c4-38ebee5ad568 2024-08-07 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 36800-072-12 36800007212 1500 mL in 1 BOTTLE, PLASTIC (36800-072-12) 1500 ml 1995-07-07 0000-00-00 No No Current 36800-072-77 36800007277 500 mL in 1 BOTTLE, PLASTIC (36800-072-77) 500 ml 1995-07-07 0000-00-00 No No Current 36800-072-86 36800007286 1000 mL in 1 BOTTLE, PLASTIC (36800-072-86) 1000 ml 1995-07-07 0000-00-00 No No Current