Home NDC 50804-664 Antispetic
Product NDC 50804-664
11-digit product format 508040664
Labeler code 50804
Product ID 50804-664_4b313926-26e6-69d9-e063-6394a90a5db0
Type HUMAN OTC DRUG
Nonproprietary name Eucalyptol, menthol, methyl salicylate, thymol
Dosage form MOUTHWASH
Route ORAL
Labeler Perrigo Direct, Inc�
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 1992-10-01
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50804-664 50804-664-13 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50804-664 50804-664-13 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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 50804-664-12 Antispetic 1500 mL in 1 BOTTLE, PLASTIC MOUTHWASH 1500 23 50804-664-13 Antispetic 1250 mL in 1 BOTTLE, PLASTIC MOUTHWASH 1250 23 50804-664-69 Antispetic 250 mL in 1 BOTTLE, PLASTIC MOUTHWASH 250 23 50804-664-86 Antispetic 1000 mL in 1 BOTTLE, PLASTIC MOUTHWASH 1000 23
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50804-664 ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [PERRIGO DIRECT INC.] 21 Current NDC, Legacy NDC, 4 package rows 20250503_cb4cf304-4f19-40cd-b480-9d89d1909684.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Antispetic EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL Perrigo Direct, Inc cb4cf304-4f19-40cd-b480-9d89d1909684 2026-02-19 Warnings, Adverse reactions Exact identifier ndc (product): 50804-664
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 50804-664-12 50804066412 1500 mL in 1 BOTTLE, PLASTIC (50804-664-12) 1500 ml 1992-10-01 0000-00-00 No No Current 50804-664-13 50804066413 1250 mL in 1 BOTTLE, PLASTIC (50804-664-13) 1250 ml 1992-10-01 0000-00-00 No No Current 50804-664-69 50804066469 250 mL in 1 BOTTLE, PLASTIC (50804-664-69) 250 ml 1992-10-01 0000-00-00 No No Current 50804-664-86 50804066486 1000 mL in 1 BOTTLE, PLASTIC (50804-664-86) 1000 ml 1992-10-01 0000-00-00 No No Current