FDA.reportPublic FDA data

Esunix Oral Bacteriostatic Gel

Product NDC
87118-006
11-digit product format
871180006
Labeler code
87118
Product ID
87118-006_45bc8e85-cabf-40fc-e063-6294a90a4427
Type
HUMAN OTC DRUG
Nonproprietary name
Cetylpyridinium Chloride
Dosage form
GEL, DENTIFRICE
Route
DENTAL
Labeler
Xiling (Zhenjiang) Medical Technology Co., Ltd.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-09-21
Substance
CETYLPYRIDINIUM CHLORIDE
Active strength
.06 g/100g
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
Esunix Oral Bacteriostatic Gel
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETYLPYRIDINIUM CHLORIDE.06 g/100g

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
2723721Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3f4ee467-8142-8cb7-e063-6394a90aa7f7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87118-006-01Esunix Oral Bacteriostatic Gel1 g in 1 TUBEGEL, DENTIFRICE13
87118-006-02Esunix Oral Bacteriostatic Gel10 in 1 BOXGEL, DENTIFRICE103

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 2 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tumeez Organic AppleCALCIUM CARBONATEBFY LLCf561685a-5260-59c6-e053-2a95a90ae2062026-08-25WarningsExact identifier
application number: M022
Ludens Watermelon Throat DropsPECTINPrestige Brands Holdings, Inc.adfb248a-96bb-4742-9df6-c47edccdd6712026-08-20WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWALMART INC. (see also Equate)584b38ce-d1ef-4ecc-a887-7c96e7f9669f2026-08-20WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWalgreensfb93c7f6-e025-4cf2-9997-acfe9a0debdd2026-08-19WarningsExact identifier
application number: M022
CVS SalineNASALCVS PHARMACYf02c41b0-c78e-41cd-aa4a-2756bbe920872026-08-19WarningsExact identifier
application number: M022
Listerine UltraClean Gum Plus Whitening Protection Cool Mint Antigingivitis/ Antiplaque MouthwashEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLC5965eb2a-1261-5258-e063-6294a90a7c2d2026-08-19WarningsExact identifier
application number: M022
Ludens Honey Licorice Throat DropsMENTHOLPrestige Brands Holdings, Inc.5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac2026-08-19WarningsExact identifier
application number: M022
Ludens Dual ReliefPECTIN AND MENTHOLPrestige Brands Holdings, Inc.d0213cb3-ec8e-40cc-82c9-694032f0490f2026-08-19WarningsExact identifier
application number: M022
CVS Health Sore Throat Fast Relief Oral AnestheticPHENOLCVS Pharmacy,Inc.4fb880db-2185-41ef-a5f9-8983a28d2c5b2026-08-17WarningsExact identifier
application number: M022
CVS Sore Throat CherryPHENOLCVS Pharmacy,Inc.887c68e0-ff44-4bad-b360-56fb99ed9c452026-08-17WarningsExact identifier
application number: M022
CVS Sore Throat Menthol FlavorPHENOLCVS PHARMACY,INC.665be058-b965-4b78-80b0-dd85241809322026-08-17WarningsExact identifier
application number: M022
Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDEHarris Teeter, LLC7e5f175d-f0d6-4665-ac14-1873d6b99c802026-08-12WarningsExact identifier
application number: M022
Gingicaine Gel Variety PakGINGICAINE GEL VARIETY PAKGingi-Pak a Division of the Belport62ed4ff3-18f6-5c67-e053-2991aa0a77922026-08-11WarningsExact identifier
application number: M022
Hydrogen Peroxide 3 Percent ReadyInCaseHYDROGEN PEROXIDEP & L Development, LLCb0866db5-3b0d-4478-9b3b-1f077d2f53932026-08-06WarningsExact identifier
application number: M022
Ollie Fresh MintSODIUM FLUORIDE, POTASSIUM NITRATEBrio Product Group LLC.ebeec44f-3c22-43f2-9256-6ece6025c1052026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.5868c5a1-273f-f023-e063-6394a90ac9d82026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.58690bb5-9604-26a4-e063-6394a90afdbe2026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.586918cf-7b13-5999-e063-6294a90a88a92026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.586924a0-322d-5dc3-e063-6294a90a15562026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.58692e90-de74-52d3-e063-6394a90a97022026-08-06WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2723721cetylpyridinium chloride 0.06 % Oral GelPSN3f4ee467-8142-8cb7-e063-6394a90aa7f73
2723721cetylpyridinium chloride 0.0006 MG/MG Oral GelSCD3f4ee467-8142-8cb7-e063-6394a90aa7f73
2723721cetylpyridinium chloride 0.06 % Oral GelSY3f4ee467-8142-8cb7-e063-6394a90aa7f73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87118-006-01871180006011 g in 1 TUBE1 gHistorical
87118-006-028711800060210 TUBE in 1 BOX (87118-006-02) / 1 g in 1 TUBE (87118-006-01) 10 tube2025-09-21NoNoCurrent