Home NDC 84516-040 Cloveden 100 times higher concentrated
Product NDC 84516-040
11-digit product format 845160040
Labeler code 84516
Product ID 84516-040_3c0e1862-2940-4d23-e063-6294a90a33e1
Type HUMAN OTC DRUG
Nonproprietary name Cetylpyridinium Chloride
Dosage form MOUTHWASH
Route ORAL
Labeler Acuseplanet Inc
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-08-01
Substance CETYLPYRIDINIUM CHLORIDE
Active strength 2.29 g/100mL
NDC exclude flag No
Listing certified through 2026-12-31
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 Cloveden 100 times higher concentrated
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CETYLPYRIDINIUM CHLORIDE 2.29 g/100mL
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 2590919 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 84516-040-01 Cloveden 100 times higher concentrated 50 mL in 1 BOTTLE MOUTHWASH 50 1 84516-040-02 Cloveden 100 times higher concentrated 1 in 1 CARTON MOUTHWASH 1 1
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 19 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Burts Bees Charcoal Peppermint SODIUM FLUORIDE Procter & Gamble Manufacturing Company a343853e-4968-2753-e053-2995a90ab152 2026-02-02 Warnings Exact identifier application number: M021 Burts Bees Complete Multi-Care SODIUM FLUORIDE Procter & Gamble Manufacturing Company 12615266-06e8-b891-e063-6394a90ad75d 2026-02-02 Warnings Exact identifier application number: M021 LIVFRESH GUM PROTECT STANNOUS FLUORIDE Livionex Inc. 1da7dcf9-e675-4b4b-8286-bdaa6e59eb0f 2026-02-02 Warnings Exact identifier application number: M021 Brush Buddies Mouthwash Disney Cars Chow Cherry SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD. 49d66ad5-cdae-52f4-e063-6294a90a8ee9 2026-02-01 Warnings Exact identifier application number: M021 Crest 3D White Deep Stain Remover Brilliant White SODIUM MONOFLUOROPHOSPHATE The Procter & Gamble Manufacturing Company 4e53a086-6cda-6460-e063-6394a90af1f3 2026-02-01 Exact identifier application number: M021 ACT Kids Berry Blast SODIUM FLUORIDE Chattem, Inc. 4f81ea98-5c74-4473-9764-3f11d627cdf1 2026-02-01 Warnings Exact identifier application number: M021 Anticavity Rinse SODIUM FLUORIDE Rite Aid Corporation c1a22692-b955-498a-a7c1-1cd7bfd54bda 2026-01-30 Warnings, Adverse reactions Exact identifier application number: M021 ARU GUM HEALTH STANNOUS FLUORIDE Ashtel Studios, Inc. d8e8b92e-d8cb-45ad-8353-7dbe43c3dcd3 2026-01-30 Warnings Exact identifier application number: M021 Colgate Anticavity SODIUM MONOFLUOROPHOSPHATE FORMIA LIMITED b5eec445-d93a-4abb-a5e3-bfcde6fa2013 2026-01-28 Warnings Exact identifier application number: M021 Supersmile Original Mint SODIUM MONOFLUOROPHOSPHATE Robell Research, Inc 24fee793-57ed-87e9-e063-6394a90ab4ce 2026-01-28 Warnings Exact identifier application number: M021 Colgate 5g and Toothbrush Dental Kit SODIUM MONOFLUOROPHOSPHATE FORMIA LIMITED 0b269f9a-aa3f-47b5-b7e8-59a5ed0e2b13 2026-01-28 Warnings Exact identifier application number: M021 Brush Buddies SPIDEY and his AMAZING FRIENDS ANTICAVITY FLUORIDE-Spidey Punch SODIUM FLUORIDE Ashtel Studios Inc. 023cb63c-52b4-4723-bff6-c25105a53f76 2026-01-28 Warnings Exact identifier application number: M021 Brush Buddies STAR WARS ANTICAVITY FLUORIDE - Saber Strike Strawberry SODIUM FLUORIDE Ashtel Studios, Inc. ef4ea4a3-c1ac-447f-a70b-e3a330928cfd 2026-01-27 Warnings Exact identifier application number: M021 Toms of Maine Tropical Island ALUMINUM CHLOROHYDRATE Tom's of Maine ae6de376-76fd-4609-a2d5-7a902c0d4c5c 2026-01-27 Warnings Exact identifier application number: M021 Made by Dentists for Kids Fluoride Anticavity Bamboolicious (Bubblegum) SODIUM FLUORIDE Made by Dentists Inc. f3f6b32d-8e47-4f52-bd9a-20bd51c9d007 2026-01-27 Warnings Exact identifier application number: M021 Brush Buddies DISNEY PRINCESS ANTICAVITY FLUORIDE - Grand Grape SODIUM FLUORIDE Ashtel Studios Inc. 6c6d143f-4c2b-4207-bde7-9df8251616a3 2026-01-27 Warnings Exact identifier application number: M021 Brush Buddies TOY STORY ANTICAVITY FLUORIDE - WILD WEST WATERMELON SODIUM FLUORIDE Ashtel Studios, Inc. d80d0a87-5d1f-4114-977a-036ffed77205 2026-01-27 Warnings Exact identifier application number: M021 Brush Buddies DISNEY FROZEN ANTICAVITY FLUORIDE - Blizzard Berry SODIUM FLUORIDE Ashtel Studios, Inc. ac18dd0a-d476-48a7-8493-594a0293b926 2026-01-27 Warnings Exact identifier application number: M021 Brush Buddies Cars ANTICAVITY FLUORIDE - KA-CHOW CHERRY SODIUM FLUORIDE Ashtel Studios, Inc. 2500e14e-6cf4-4ac4-810f-1ef163c5e474 2026-01-27 Warnings Exact identifier application number: M021 Hello Unicorn Splash SODIUM FLUORIDE Accupac LLC 23807810-990a-b723-e063-6394a90aee3e 2026-01-22 Warnings Exact identifier application number: M021
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84516-040-01 84516004001 50 mL in 1 BOTTLE 50 ml Historical 84516-040-02 84516004002 1 BOTTLE in 1 CARTON (84516-040-02) / 50 mL in 1 BOTTLE (84516-040-01) 1 bottle 2025-08-01 No No Current