Home NDC 72164-009 twice. Oral Wellness Gum Shield
Product NDC 72164-009
11-digit product format 721640009
Labeler code 72164
Product ID 72164-009_4e81d963-f1ce-c398-e063-6394a90a6fd1
Type HUMAN OTC DRUG
Nonproprietary name Cetylpyridinium Chloride
Dosage form RINSE
Route ORAL
Labeler Twice Twice LLC
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-08-01
Substance CETYLPYRIDINIUM CHLORIDE
Active strength .5 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 twice. Oral Wellness Gum Shield
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CETYLPYRIDINIUM CHLORIDE .5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination D9OM4SK49P Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1251617 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72164-009-20 twice. Oral Wellness Gum Shield 591 mL in 1 BOTTLE RINSE 591 3
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 72164-009-20 72164000920 591 mL in 1 BOTTLE (72164-009-20) 591 ml 2025-08-01 No No Current