Home NDC 57243-664-69 Antispetic
Product NDC 57243-664
Requested package NDC 57243-664-69
11-digit product format 572430664
Labeler code 57243
Product ID 57243-664_4a2d2d09-942f-46cf-e063-6394a90aaa8a
Type HUMAN OTC DRUG
Nonproprietary name Eucalyptol, menthol, methyl salicylate, thymol
Dosage form MOUTHWASH
Route ORAL
Labeler Salado Sales Inc.
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2010-06-04
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 Additional Listing Data#
Finished product Yes
Brand name base Antispetic
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 57243-664-69 Antispetic 250 mL in 1 BOTTLE, PLASTIC MOUTHWASH 250 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded EUCALYPTOL ACTIVE INGREDIENT RV6J6604TK ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SALADO SALES, INC.] 1 MENTHOL ACTIVE INGREDIENT L7T10EIP3A ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SALADO SALES, INC.] 1 METHYL SALICYLATE ACTIVE INGREDIENT LAV5U5022Y ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SALADO SALES, INC.] 1 THYMOL ACTIVE INGREDIENT 3J50XA376E ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SALADO SALES, INC.] 1 EUCALYPTOL ACTIVE MOIETY RV6J6604TK ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SALADO SALES, INC.] 1 MENTHOL ACTIVE MOIETY L7T10EIP3A ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SALADO SALES, INC.] 1 SALICYLIC ACID ACTIVE MOIETY O414PZ4LPZ ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SALADO SALES, INC.] 1 THYMOL ACTIVE MOIETY 3J50XA376E ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SALADO SALES, INC.] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SALADO SALES, INC.] 1 BENZOIC ACID INACTIVE INGREDIENT 8SKN0B0MIM ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SALADO SALES, INC.] 1 FD&C GREEN NO. 3 INACTIVE INGREDIENT 3P3ONR6O1S ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SALADO SALES, INC.] 1 POLOXAMER 407 INACTIVE INGREDIENT TUF2IVW3M2 ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SALADO SALES, INC.] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SALADO SALES, INC.] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SALADO SALES, INC.] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SALADO SALES, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SALADO SALES, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57243-664 ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SALADO SALES, INC.] 16 Current NDC, Legacy NDC, 1 package rows 20250429_c99a8a64-b328-45a3-8ef9-353b40dc20e4.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 1 of 1 · 1 matching rows.
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 57243-664-69 57243066469 250 mL in 1 BOTTLE, PLASTIC (57243-664-69) 250 ml 2010-06-04 0000-00-00 No No Current