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 86 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Freds Hydrocortisone Plus 12 Moisturizers HYDROCORTISONE FRED'S, INC. 7502eebe-11c5-4e9e-b427-b87180a84349 2025-07-16 Warnings Exact identifier application number: M017 PROINNATE Numbing Cream MENTHOL Guangzhou Haishi Biological Technology Co., Ltd. 39688b2b-c1fe-cd86-e063-6394a90a5345 2025-07-16 Warnings Exact identifier application number: M017 Methyl Salicylate METHYL SALICYLATE ViolaCare, Inc. 8f0ba6e7-8aa4-443e-99ae-a255085ddfec 2025-07-15 Warnings Exact identifier application number: M017 TopCare Hydrocortisone Intensive Healing Formula HYDROCORTISONE Topco Associates LLC 7daafc44-e2a4-4f1b-bfca-3309a8e9a920 2025-07-15 Warnings Exact identifier application number: M017 Hydrocortisone Plus 12 Moisturizers HYDROCORTISONE TARGET Corporation 72c3889c-b743-4728-a315-6e4063e00200 2025-07-15 Warnings Exact identifier application number: M017 Shopko Hydrocortisone Maximum Strength HYDROCORTISONE Shopko Stores Operating Co., LLC 0431a6af-4c9a-4bbd-a535-cba31a5e53cc 2025-07-15 Warnings Exact identifier application number: M017 Freds Hydrocortisone with Aloe HYDROCORTISONE FRED'S, INC. 076503bf-8238-4739-bb1c-c385e72f8a96 2025-07-15 Warnings Exact identifier application number: M017 Shopko Hydrocortisone HYDROCORTISONE Shopko Stores Operating Co., LLC 92bcbde3-401a-4301-854e-c352852317d6 2025-07-15 Warnings Exact identifier application number: M017 TopCare Hydrocortisone HYDROCORTISONE Topco Associates LLC bd3585fa-3b48-49b7-8ad1-749bf1e31ed5 2025-07-15 Warnings Exact identifier application number: M017 Methyl Salicylate 25% Pain Relieving METHYL SALICYLATE Puretek Corporation 376797ff-cf13-a3c6-e063-6394a90a9de1 2025-07-15 Warnings Exact identifier application number: M017 TIGER BALM PAIN RELIEVING CAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUM Haw Par Healthcare Ltd. 440e97bc-bd97-4733-9955-643b18e7fb18 2025-07-15 Warnings Exact identifier application number: M017 Tiger Balm Pain Relieving Hydrogel Large CAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUM Haw Par Healthcare Ltd. 064d04ca-184d-492b-867c-beaa165ab3e0 2025-07-14 Warnings Exact identifier application number: M017 Methyl Salicylate 25% Cream METHYL SALICYLATE Medcore LLC 143f76bf-2de4-466a-8a6b-d6ab6314a2c3 2025-07-14 Warnings Exact identifier application number: M017 BLUESPRING Doctors Pain Formula Pain Relief MENTHOL ACA MANAGEMENT LLC 98f3f719-792f-4a93-95b1-90072e0f8bf4 2025-07-14 Warnings Exact identifier application number: M017 Shopko Anti-Itch DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE Shopko Stores Operating Co., LLC 130119eb-b87e-4a07-8d2a-317369bfa541 2025-07-14 Warnings Exact identifier application number: M017 Equate Hydrocortisone Intensive Healing Formula HYDROCORTISONE Wal-Mart Stores Inc. 635b49c4-54d2-4b6d-bee8-851fc2c7ca9c 2025-07-14 Warnings Exact identifier application number: M017 ULTRA STRENGTH ZHENG GU SHUI MENTHOL AND CAMPHOR GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD 53397663-044d-4e48-989b-2c6257af5f84 2025-07-14 Warnings, Adverse reactions Exact identifier application number: M017 TIGER BALM PAIN RELIEVING HYDROGEL CAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUM Haw Par Healthcare Ltd. cb60037f-bceb-4090-a5e4-bdda0cbf9f5c 2025-07-14 Warnings Exact identifier application number: M017 Avedana Hydrocortisone Cream with Aloe HYDROCORTISONE Unipack LLC 2a55c426-39b4-4d94-b6b4-6c548c9685e9 2025-07-13 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE ACETATE Rite Aid Corporation cb6e0bed-2ea1-49d2-89e7-2554e7565b74 2025-07-11 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