Home NDC 87638-002 anzoon ANTIBACTERIAL MOUTH WASH
Product NDC 87638-002
11-digit product format 876380002
Labeler code 87638
Product ID 87638-002_507c6896-2807-790c-e063-6394a90ac5ce
Type HUMAN OTC DRUG
Nonproprietary name Cetylpyridinium Chloride
Dosage form LIQUID
Route TOPICAL
Labeler Shandong AZC Biotechnology Co.,Ltd.
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-04-28
Substance CETYLPYRIDINIUM CHLORIDE
Active strength .027 g/100mL
NDC exclude flag No
Listing certified through 2027-12-31
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 anzoon ANTIBACTERIAL MOUTH WASH
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CETYLPYRIDINIUM CHLORIDE .027 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 2741388 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 87638-002-01 anzoon ANTIBACTERIAL MOUTH WASH 10 mL in 1 BOTTLE LIQUID 10 1 87638-002-02 anzoon ANTIBACTERIAL MOUTH WASH 15 mL in 1 BOTTLE LIQUID 15 1 87638-002-03 anzoon ANTIBACTERIAL MOUTH WASH 60 mL in 1 BOTTLE LIQUID 60 1 87638-002-04 anzoon ANTIBACTERIAL MOUTH WASH 100 mL in 1 BOTTLE LIQUID 100 1 87638-002-05 anzoon ANTIBACTERIAL MOUTH WASH 260 mL in 1 BOTTLE LIQUID 260 1 87638-002-06 anzoon ANTIBACTERIAL MOUTH WASH 300 mL in 1 BOTTLE LIQUID 300 1 87638-002-07 anzoon ANTIBACTERIAL MOUTH WASH 500 mL in 1 BOTTLE LIQUID 500 1 87638-002-08 anzoon ANTIBACTERIAL MOUTH WASH 1000 mL in 1 BOTTLE LIQUID 1000 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 48 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join EUTHYMOL Extraordinary Pink Whitening SODIUM FLUORIDE LG H&H CO., LTD. 13910b55-9b5d-af53-e063-6294a90acf5d 2024-03-13 Warnings Exact identifier application number: M021 BIO SPECTRA ATTITUDE SODIUM FLUORIDE 9055-7588 Quebec Inc. DBA Attitude e3bb60f8-2a06-42d6-a182-8c31bb982a2a 2024-03-01 Warnings Exact identifier application number: M021 Maximum Security SODIUM FLUORIDE Bob Barker Company Inc. e29f30ec-72ea-4944-a2c2-b1696d31b639 2024-02-27 Warnings Exact identifier application number: M021 Made by Dentists For Kids Monster Slime Sour Apple SODIUM FLUORIDE MADE BY DENTISTS INC dfddc67c-3626-48c4-8120-bcc6c455d119 2024-02-23 Warnings Exact identifier application number: M021 Orajel Gabbys Dollhouse SODIUM FLUORIDE Church & Dwight Co., Inc. cd47bd1e-44ac-465f-8529-6073ade14706 2024-02-23 Warnings Exact identifier application number: M021 Colgate Kids Maximum Cavity Protection SODIUM FLUORIDE Colgate-Palmolive c44c7a7e-fc3e-a81b-1961-ff89614b678f 2024-02-22 Warnings Exact identifier application number: M021 TheraBreath Fresh Breath Anticavity Mild Mint SODIUM FLUORIDE Church & Dwight Co., Inc. 19ce5324-7d8d-4d70-ad9b-238f7e612eac 2024-02-06 Warnings Exact identifier application number: M021 Nature Mint Anticavity SODIUM MONOFLUOROPHOSPHATE Bob Barker Company Inc. 916891d3-5234-46a8-a492-21a31f36a852 2024-02-02 Warnings Exact identifier application number: M021 Treatment Rinse Mint ANTICARIES DENTAL ALLIANCE HOLDINGS LLC f1255065-b7c3-4eb6-e053-2995a90afcdb 2024-01-31 Warnings Exact identifier application number: M021 Maintenance Rinse Mint ANTICARIES Dental Alliance Holdings LLC f1273510-aa83-3ef9-e053-2a95a90aea27 2024-01-31 Warnings Exact identifier application number: M021 ATOMY PROPOLIS TOOTHPAS TE 50G SODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDE ATOMY CO., LTD. 98d839e3-a1aa-c83d-e053-2995a90a7e79 2024-01-30 Warnings Exact identifier application number: M021 ATOMY PROPOLIS TOOTHPAS TE 200G SODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDE ATOMY CO., LTD. 98aebbec-aec0-1478-e053-2a95a90a03ea 2024-01-30 Warnings Exact identifier application number: M021 Toms Childrens Anticavity Mouthwash Silly Strawberry SODIUM FLUORIDE Tom's of Maine, Inc. 998c6f35-20f4-4cb8-bc48-6aa39e61481a 2024-01-18 Warnings Exact identifier application number: M021 Gel-Kam Fruit and Berry STANNOUS FLUORIDE Colgate Oral Pharmaceuticals, Inc. 8c2c3c5c-ddef-4a4d-8bc3-5a98c577e74c 2024-01-18 Warnings Exact identifier application number: M021 Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride SODIUM FLUORIDE Colgate Oral Pharmaceuticals, Inc. 9a976ac8-d966-4d94-93da-45652f2d2481 2024-01-12 Warnings Exact identifier application number: M021 Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Mint Fluoride SODIUM FLUORIDE Colgate Oral Pharmaceuticals, Inc. 2b4b6f9a-0e31-4891-8721-d1b9a58cca96 2024-01-12 Warnings Exact identifier application number: M021 Colgate MaxFresh with Mini Breath Cool Mint SODIUM FLUORIDE Colgate-Palmolive Company 51abd6bc-7a3d-4b0e-a810-af9e94926438 2024-01-09 Warnings Exact identifier application number: M021 Colgate Enamel Strength Mouthwash SODIUM FLUORIDE Colgate-Palmolive - do not use f0cca38b-c0a3-4788-8cca-727a5684c16b 2024-01-09 Warnings Exact identifier application number: M021 PerCara Oral Health Rinse Fresh Mint CETYLPYRIDINIUM CHLORIDE LEC Custom Products, Inc bd98c654-218b-15ac-e053-2a95a90a75d1 2024-01-01 Warnings Exact identifier application number: M021 PerCara Kids Bubble Gum SODIUM FLUORIDE LEC Custom Products, Inc. be3a7272-acfb-7d14-e053-2995a90a9420 2024-01-01 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 87638-002-01 87638000201 10 mL in 1 BOTTLE (87638-002-01) 10 ml 2026-04-28 No No Current 87638-002-02 87638000202 15 mL in 1 BOTTLE (87638-002-02) 15 ml 2026-04-28 No No Current 87638-002-03 87638000203 60 mL in 1 BOTTLE (87638-002-03) 60 ml 2026-04-28 No No Current 87638-002-04 87638000204 100 mL in 1 BOTTLE (87638-002-04) 100 ml 2026-04-28 No No Current 87638-002-05 87638000205 260 mL in 1 BOTTLE (87638-002-05) 260 ml 2026-04-28 No No Current 87638-002-06 87638000206 300 mL in 1 BOTTLE (87638-002-06) 300 ml 2026-04-28 No No Current 87638-002-07 87638000207 500 mL in 1 BOTTLE (87638-002-07) 500 ml 2026-04-28 No No Current 87638-002-08 87638000208 1000 mL in 1 BOTTLE (87638-002-08) 1000 ml 2026-04-28 No No Current