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 13 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CloSYSSODIUM FLUORIDERowpar Pharmaceuticals, Inc.ed617c7a-805c-4788-9bce-9b7fead4312d2026-03-31WarningsExact identifier
application number: M021
Colgate Total Enamel StrengthSTANNOUS FLUORIDEColgate-Palmolive Company1f29c893-e7c5-4a0e-941b-c2634d8211472026-03-25WarningsExact identifier
application number: M021
AP-24 WhiteningSODIUM MONOFLUOROPHOSPHATENSE Products, Inc.57e9e68c-41dd-470b-80db-dfaedc0e2a0a2026-03-24WarningsExact identifier
application number: M021
Euthymol WhiteningSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.369c0d44-6375-dcae-e063-6394a90a74d02026-03-24WarningsExact identifier
application number: M021
Euthymol Whitening Purple CorrectorSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.369bc785-fb77-a56d-e063-6394a90a2e6b2026-03-24WarningsExact identifier
application number: M021
SensitiveToothpasteANTI SENSITIVETOOTHPASTEHuain Best Trade Co., Ltd.4db239f3-2ad7-3a5b-e063-6294a90a11a72026-03-23WarningsExact identifier
application number: M021
Crest BubblegumSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company7d6268c7-b273-1bbf-e053-2a91aa0a5d322026-03-17WarningsExact identifier
application number: M021
Natures Promise Childrens Fluoride StrawberrySODIUM MONOFLUOROPHOSPHATEFoodhold U.S.A.81a4e196-8b2d-0745-e053-2991aa0a7de62026-03-16WarningsExact identifier
application number: M021
Stance0.63% STANNOUS FLUORIDE CONCENTRATE RINSEElevate Oral Care3ae8badf-f960-62fd-e054-00144ff8d46c2026-03-11WarningsExact identifier
application number: M021
Stance0.63% STANNOUS FLUORIDE CONCENTRATE RINSEElevate Oral Care3ae71258-a8c2-6eb5-e054-00144ff88e882026-03-11WarningsExact identifier
application number: M021
Delta Travel Kit Comfort plusSODIUM MONOFLUOROPHOSPHATEBuzz Products Inc.d31e0920-4317-1e0c-e053-2a95a90aebeb2026-03-11WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDECVS Pharmacy, Inc.eac346d9-d9c1-4417-8193-390c7a0dcc2a2026-03-10Warnings, Adverse reactionsExact identifier
application number: M021
Crest Cavity Protection RegularSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company6caf3f2e-70a2-4530-99fa-f5af7e4c511a2026-03-10WarningsExact identifier
application number: M021
Amerfresh ToothpowderSODIUM FLUORIDEYangzhou ONE & ONLY Personal Care Products Co., LTD1cacf93e-aa60-4717-87ab-0568a701a4f32026-03-10WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDECVS Pharmacy, Inc.a51357df-6d55-4030-a5db-42da7ba54a372026-03-09Warnings, Adverse reactionsExact identifier
application number: M021
FluorideFLUORIDE TOOTHPASTEMcKesson4c482e45-0502-a93a-e063-6394a90aa9612026-03-05WarningsExact identifier
application number: M021
Colgate Maximum Cavity Protection Bubble Fruit FlavorSODIUM FLUORIDEColgate-Palmolive Company0a1389f6-cac9-3d58-0744-c488abb0bbcc2026-03-03WarningsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDEAmazon.com Services LLC349eca80-2e0c-409b-af29-3235fdc0695b2026-03-03Warnings, Adverse reactionsExact identifier
application number: M021
Oral AntivavitySODIUM FLUORIDEAmazon.com Services LLC03735abc-d1be-4ca0-a497-0a5c5f2894022026-03-03Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEOld East Main Co.f8036e2e-7541-4922-92b9-0d8319f7b64c2026-03-02Warnings, Adverse reactionsExact 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