FDA.reportPublic FDA data

chlorhexidine gluconate 1.2 MG/ML Mouthwash [Nupro Chlorhexidine]

RxCUI
1869723
RxNorm name
chlorhexidine gluconate 1.2 MG/ML Mouthwash [Nupro Chlorhexidine]
Display name
NUPRO CHLORHEXIDINE (Mouthwash)
Full name
chlorhexidine gluconate 1.2 MG/ML Mouthwash [Nupro Chlorhexidine]
Term type
SBD
Status
Active
Strength
0.12%
Dose form
Mouthwash
Route
Mouthwash
Updated
2026-11-11 03:17:39

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
032017
Active start
032017
Multiple ingredient
NO
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
chlorhexidine gluconate1.2 MG / 1 MLchlorhexidinechlorhexidine gluconate

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Mouthwash7067

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
chlorhexidine2358

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRNupro Chlorhexidine 0.12 % Mouthwash1NAMES
RxNorm Namechlorhexidine gluconate 1.2 MG/ML Mouthwash [Nupro Chlorhexidine]1NAMES
RxNorm Synonym
2 linked values
2NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID
2 linked values
2CODES
RxCUI18697231CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0116-0800-160116-0800NUPRO Chlorhexidine Gluconate CHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.ANDA077789
65222-800-1665222-800NUPRO Chlorhexidine Gluconate CHLORHEXIDINE GLUCONATEDentsply LLC. Professional Division Trading as "DENTSPLY Professional"ANDA077789

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA0777890116-0800NUPRO Chlorhexidine Gluconate CHLORHEXIDINE GLUCONATEANDAXttrium Laboratories, Inc.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 2 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00116080016rxnav_ndcsyes
65222080016rxnav_ndcsyes

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NUPRO Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.4a3b87bc-d913-6c88-e054-00144ff8d46c2025-04-30Warnings, Adverse reactionsExact identifier
ndc (package): 0116-0800-16
ndc (product): 0116-0800
ndc11 (package): 00116080016
rxcui: 1869723
NUPRO Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEDentsply LLC. Professional Division Trading as "DENTSPLY Professional"d9d25abd-c3b4-4713-91c7-538f98e8fb702024-12-24Warnings, Adverse reactionsExact identifier
ndc (package): 65222-800-16
ndc (product): 65222-800
ndc11 (package): 65222080016
rxcui: 1869723

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
4a3b87bc-d913-6c88-e054-00144ff8d46cNupro Chlorhexidine 0.12 % Oral Rinse [PSN] · chlorhexidine gluconate 1.2 MG/ML Mouthwash [Nupro Chlorhexidine] [SBD] · Nupro Chlorhexidine 0.12 % Mouthwash [SY] · Nupro Chlorhexidine 1.2 MG/ML Mouthwash [SY]47NUPRO DENTSPLY Chlorhexidine Gluconate 0.12%, USP20250430
d9d25abd-c3b4-4713-91c7-538f98e8fb70Nupro Chlorhexidine 0.12 % Oral Rinse [PSN] · chlorhexidine gluconate 1.2 MG/ML Mouthwash [Nupro Chlorhexidine] [SBD] · Nupro Chlorhexidine 0.12 % Mouthwash [SY] · Nupro Chlorhexidine 1.2 MG/ML Mouthwash [SY]44NUPRO Chlorhexidine Gluconate – chlorhexidine gluconate rinse DENTSPLY Professional20241224

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
4a3b87bc-d913-6c88-e054-00144ff8d46cNUPRO DENTSPLY Chlorhexidine Gluconate 0.12%, USPXttrium Laboratories, Inc.20250430
d9d25abd-c3b4-4713-91c7-538f98e8fb70NUPRO Chlorhexidine Gluconate – chlorhexidine gluconate rinse DENTSPLY ProfessionalDentsply LLC. Professional Division Trading as "DENTSPLY Professional" | Xttrium Laboratories, Inc.20241224

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCS03AAAntiinfectivesATC1-4chlorhexidine
ATCS02AAAntiinfectivesATC1-4chlorhexidine
ATCB05CAAntiinfectivesATC1-4chlorhexidine
ATCA01ABAntiinfectives and antiseptics for local oral treatmentATC1-4chlorhexidine
ATCR02AAAntisepticsATC1-4chlorhexidine
ATCD08ACBiguanides and amidinesATC1-4chlorhexidine
ATCD09AAMedicated dressings with antiinfectivesATC1-4chlorhexidine
ATCS01AXOther antiinfectivesATC1-4chlorhexidine
FDASPLN0000008478Decreased Cell Wall IntegrityPEhas_pechlorhexidine
MEDRTD002710ChlorhexidineCHEMhas_ingredientchlorhexidine gluconate
MEDRTD002710ChlorhexidineCHEMhas_ingredientchlorhexidine
MEDRTD002180Candidiasis, OralDISEASEmay_treatchlorhexidine
MEDRTD002180Candidiasis, OralDISEASEmay_treatchlorhexidine gluconate
MEDRTD004342Drug HypersensitivityDISEASEci_withchlorhexidine
MEDRTD004342Drug HypersensitivityDISEASEci_withchlorhexidine gluconate
MEDRTD016905Gram-Negative Bacterial InfectionsDISEASEmay_treatchlorhexidine
MEDRTD016905Gram-Negative Bacterial InfectionsDISEASEmay_treatchlorhexidine gluconate
MEDRTD016908Gram-Positive Bacterial InfectionsDISEASEmay_treatchlorhexidine
MEDRTD016908Gram-Positive Bacterial InfectionsDISEASEmay_treatchlorhexidine gluconate
MEDRTD010510Periodontal DiseasesDISEASEmay_treatchlorhexidine
MEDRTD010510Periodontal DiseasesDISEASEmay_treatchlorhexidine gluconate
MEDRTD012874Skin Diseases, InfectiousDISEASEmay_treatchlorhexidine
MEDRTD012874Skin Diseases, InfectiousDISEASEmay_treatchlorhexidine gluconate
MEDRTN0000000065Physiochemical ActivityMOAhas_moachlorhexidine gluconate
MEDRTN0000000065Physiochemical ActivityMOAhas_moachlorhexidine
MEDRTN0000008478Decreased Cell Wall IntegrityPEhas_pechlorhexidine gluconate
MEDRTN0000008478Decreased Cell Wall IntegrityPEhas_pechlorhexidine

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH1.2 MG/ML (expressed as chlorhexidine gluconate)
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
CODESANDAANDA077789
NAMESPrescribable SynonymNupro Chlorhexidine 0.12 % Oral Rinse
SOURCESSourceMetathesaurus FDA Structured Product Labels