Home NDC 11344-318-69 Antiseptic Mouth Rinse
Product NDC 11344-318
Requested package NDC 11344-318-69
11-digit product format 113440318
Labeler code 11344
Product ID 11344-318_4cea14c9-e252-2e4f-e063-6294a90a5205
Type HUMAN OTC DRUG
Nonproprietary name Eucalyptol, Menthol, Methyl Salicylate, Thymol
Dosage form MOUTHWASH
Route ORAL
Labeler Nice-Pak Products, LLC
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2001-01-04
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 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 · 7 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 11344-318-69 Antiseptic Mouth Rinse 250 mL in 1 BOTTLE, PLASTIC MOUTHWASH 250 7 11344-318-77 Antiseptic Mouth Rinse 500 mL in 1 BOTTLE, PLASTIC MOUTHWASH 500 7 11344-318-86 Antiseptic Mouth Rinse 1000 mL in 1 BOTTLE, PLASTIC MOUTHWASH 1000 7
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11344-318 ANTISEPTIC MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [CONSUMER PRODUCT PARTNERS, LLC] 6 Current NDC, Legacy NDC, 3 package rows 20250423_5b9c19a1-e3c0-4bed-92dd-8bff48477e2e.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 Sample Exclude flag Status 11344-318-69 11344031869 250 mL in 1 BOTTLE, PLASTIC (11344-318-69) 250 ml 2001-01-04 No No Current