FDA.reportPublic FDA data

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
IngredientStrength
CETYLPYRIDINIUM CHLORIDE.027 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
D9OM4SK49PInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2741388Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
507c6896-2806-790c-e063-6394a90ac5ceAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87638-002-01anzoon ANTIBACTERIAL MOUTH WASH10 mL in 1 BOTTLELIQUID101
87638-002-02anzoon ANTIBACTERIAL MOUTH WASH15 mL in 1 BOTTLELIQUID151
87638-002-03anzoon ANTIBACTERIAL MOUTH WASH60 mL in 1 BOTTLELIQUID601
87638-002-04anzoon ANTIBACTERIAL MOUTH WASH100 mL in 1 BOTTLELIQUID1001
87638-002-05anzoon ANTIBACTERIAL MOUTH WASH260 mL in 1 BOTTLELIQUID2601
87638-002-06anzoon ANTIBACTERIAL MOUTH WASH300 mL in 1 BOTTLELIQUID3001
87638-002-07anzoon ANTIBACTERIAL MOUTH WASH500 mL in 1 BOTTLELIQUID5001
87638-002-08anzoon ANTIBACTERIAL MOUTH WASH1000 mL in 1 BOTTLELIQUID10001

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 26 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Complete plus Whitening plus ScopeSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc5d5bc17-e81b-34aa-e053-2a95a90ad77f2026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Advanced Gum Restore Deep CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc5745cc4-213d-1dde-e053-2995a90af5622026-01-08WarningsExact identifier
application number: M021
Crest 3D White Stain ShieldSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company960fef18-4533-5250-e053-2995a90aaf762026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Advanced Gum Restore WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc574b51d-07bd-b363-e053-2995a90a7c0e2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Brilliance BlastSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company6d9a1754-8d38-054f-e053-2991aa0a46532026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Breath Purify and Gum Deep CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc60fdacf-d997-19a5-e053-2a95a90a96a32026-01-08WarningsExact identifier
application number: M021
Crest Cavity Protection Cool Mint GelSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company3d7fffb9-47e0-73cd-e054-00144ff88e882026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Gum Detoxify UltraSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc73ed36a-0e2f-a137-e053-2a95a90a43e02026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Advanced Extra WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc688d37e-9e80-4599-e053-2a95a90a19162026-01-08WarningsExact identifier
application number: M021
Crest Gum Detoxify plus WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company63779942-0f6c-11c5-e053-2991aa0a25ab2026-01-08WarningsExact identifier
application number: M021
Crest Premium Plus Sensitivity Active FoamSODIUM FLUORIDE AND POTASSIUM NITRATEThe Procter & Gamble Manufacturing Companyb8535d1c-cf15-f353-e053-2a95a90a79742026-01-08WarningsExact identifier
application number: M021
Burts Bees Extra White Zen PeppermintSODIUM FLUORIDEProcter & Gamble Manufacturing Company81279e1f-6224-8114-e053-2991aa0aab082026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Bacteria Shield and Gum Deep CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc74229c4-b095-df32-e053-2a95a90a4aec2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Brilliance Advanced Whitening Fresh MintSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Companyc8350ab3-9347-58c0-e053-2995a90a72382026-01-08Exact identifier
application number: M021
Crest Premium Plus Anti-BacterialSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyb7af946e-1cac-b8c0-e053-2a95a90afa4a2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Stain Eraser Polishing MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyddcb0871-9900-125f-e053-2a95a90a75de2026-01-08Exact identifier
application number: M021
Burts Bees Deep Clean plus WhiteningSODIUM FLUORIDEProcter & Gamble Manufacturing Companyc924b8dd-8d84-1329-e053-2995a90a45312026-01-08WarningsExact identifier
application number: M021
Crest Plus Baking Soda and Peroxide Whitening with Tartar ProtectionSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company07ed767e-225c-e9c5-e063-6394a90af9312026-01-08WarningsExact identifier
application number: M021
Crest Plus Cavity Protection Cool Mint GelSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company0813171e-bda5-b004-e063-6394a90ad3642026-01-08WarningsExact identifier
application number: M021
Burts Bees Kids Strawberry SplashSODIUM FLUORIDEProcter & Gamble Manufacturing Company087b3434-2636-74ce-e063-6394a90a25ad2026-01-08WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2741388cetylpyridinium chloride 0.027 % MouthwashPSN507c6896-2806-790c-e063-6394a90ac5ce1
2741388cetylpyridinium chloride 0.27 MG/ML MouthwashSCD507c6896-2806-790c-e063-6394a90ac5ce1
2741388cetylpyridinium chloride 0.027 % MouthwashSY507c6896-2806-790c-e063-6394a90ac5ce1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87638-002-018763800020110 mL in 1 BOTTLE (87638-002-01) 10 ml2026-04-28NoNoCurrent
87638-002-028763800020215 mL in 1 BOTTLE (87638-002-02) 15 ml2026-04-28NoNoCurrent
87638-002-038763800020360 mL in 1 BOTTLE (87638-002-03) 60 ml2026-04-28NoNoCurrent
87638-002-0487638000204100 mL in 1 BOTTLE (87638-002-04) 100 ml2026-04-28NoNoCurrent
87638-002-0587638000205260 mL in 1 BOTTLE (87638-002-05) 260 ml2026-04-28NoNoCurrent
87638-002-0687638000206300 mL in 1 BOTTLE (87638-002-06) 300 ml2026-04-28NoNoCurrent
87638-002-0787638000207500 mL in 1 BOTTLE (87638-002-07) 500 ml2026-04-28NoNoCurrent
87638-002-08876380002081000 mL in 1 BOTTLE (87638-002-08) 1000 ml2026-04-28NoNoCurrent