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 49 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Murchison Hume Dental KitSODIUM MONOFLUOROPHOSPHATEBuzz Products Inc.b1a442e1-86cf-cba6-e053-2995a90a593a2023-12-20WarningsExact identifier
application number: M021
United Airlines Polaris Kit with ColgateSODIUM MONOFLUOROPHOSPHATEBuzz Export Services Pty Ltd (Buzz Products)de4564a4-1012-baad-e053-2a95a90a11b72023-12-20WarningsExact identifier
application number: M021
Orajel Complete ProtectionSODIUM FLUORIDEChurch & Dwight Co., Inc.daebd16f-d278-446d-8b7a-33add5a74fdd2023-12-19WarningsExact identifier
application number: M021
Orajel Sensitivity ReliefSODIUM FLUORIDE AND POTASSIUM NITRATEChurch & Dwight Co., Inc.7b9d9e7d-3844-4d18-ab03-bd0e9dcfccdb2023-12-19WarningsExact identifier
application number: M021
ORTHO GUARDSODIUM FLUORIDEMassco Dental A Division of Dunagin Pharmaceuticals8d3e0dd0-b584-413b-adf3-5c2d05ab72dd2023-12-17WarningsExact identifier
application number: M021
Beyond Activated Coconut Charcoal and Sea SaltSODIUM FLUORIDEBeyond International Incd075fa15-7309-0c10-e053-2995a90a7c952023-11-28WarningsExact identifier
application number: M021
Pro-Den RxSTANNOUS FLUORIDEDen-mat Holdings, Llc9036aa8a-59b1-41b0-b3cb-529d3303a1c02023-11-20WarningsExact identifier
application number: M021
FluoridexSTANNOUS FLUORIDE RINSEDEN-MAT HOLDINGS, LLC5e81f073-c0ca-aa38-e053-2a91aa0ab37b2023-11-20WarningsExact identifier
application number: M021
Hello Vitamin C WhiteningSODIUM FLUORIDEColgate-Palmolive Company38a0276e-910c-527d-1736-65928b9d4ca42023-11-20WarningsExact identifier
application number: M021
POP Feeling PeachySODIUM FLUORIDELG H&H CO., LTD.0abaf99b-9547-46ae-e063-6394a90a6c152023-11-17WarningsExact identifier
application number: M021
UNIVERSAL ANTI-CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEUniversal Distribution Center LLCe3356374-befa-41b0-ab0f-edfd5a0626012023-11-16WarningsExact identifier
application number: M021
ANTI CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEUniversal Distribution Center LLC421fc2f0-b118-4e7a-a399-ba4780028c542023-11-16WarningsExact identifier
application number: M021
UNIVERSAL CHARCOAL WITH ALOE VERA ANTI-CAVITY FLUORIDESODIUM FLUORIDEUniversal Distribution Center LLC3411924d-1002-460c-83e8-c0c7fbff9ad12023-11-16WarningsExact identifier
application number: M021
ADVANCED WHITENING ANTI CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEUniversal Distribution Center LLC8ea8a8d9-b7e4-468f-9a09-4ec634cbd80e2023-11-16WarningsExact identifier
application number: M021
UNIVERSAL ADVANCED WHITENING ANTI-CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEUniversal Distribution Center LLC879dfaf0-27c8-41a3-8d01-a1c3eec9edfc2023-11-15WarningsExact identifier
application number: M021
EUTHYMOL Extraordinary Pink WhiteningSODIUM FLUORIDELG H&H CO., LTD.0989936c-237d-dc63-e063-6294a90a885f2023-11-07WarningsExact identifier
application number: M021
Eurofresh WhiteningSODIUM FLUORIDEFarmasi US LLCb56b2b55-e3a4-785a-e053-2a95a90a7abf2023-11-05WarningsExact identifier
application number: M021
Farmasi WhiteningSODIUM FLUORIDEFarmasi US LLC25b3608e-abed-41ca-9971-21981b8a46102023-11-05WarningsExact identifier
application number: M021
United Airlines Therabody UPP KitSODIUM MONOFLUOROPHOSPHATEWessco Internationalfb6c355b-a67d-c4b4-e053-6394a90a0e662023-10-26WarningsExact identifier
application number: M021
United Dental KitSODIUM MONOFLUOROPHOSPHATEWessco International7f348fe7-9918-4934-bed0-f0a77c09d0462023-10-26WarningsExact 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