FDA.reportPublic FDA data

Peridex

Product NDC
48878-0620
11-digit product format
488780620
Labeler code
48878
Product ID
48878-0620_88264ba1-fa70-4e87-8289-a48539ce55aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
chlorhexidine gluconate
Dosage form
RINSE
Route
ORAL
Labeler
Solventum US LLC
Application
NDA019028
Marketing category
NDA
Marketing start
1986-08-13
Substance
CHLORHEXIDINE GLUCONATE
Active strength
1.2 mg/mL
Pharmacologic classes
Decreased Cell Wall Integrity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019028-001PERIDEXCHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTALATRLD, RS1986-08-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N019028-001AT

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N019028-001PERIDEX0.12%SOLUTION / DENTALATRLD, RS1986-08-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N019028-001AT1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PeridexCHLORHEXIDINE GLUCONATESolventum US LLC3fcd41c4-875a-4e54-b533-261f198011af2024-08-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 019028
application number: NDA019028
ndc (product): 48878-0620

Additional Listing Data#

Finished product
Yes
Brand name base
Peridex
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORHEXIDINE GLUCONATE1.2 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
MOR84MUD8EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
834127Internal RxNorm lookup
834135Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3fcd41c4-875a-4e54-b533-261f198011afAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48878-0620-1Peridex473 mL in 1 BOTTLERINSE47319
48878-0620-2Peridex1893 mL in 1 BOTTLE, DISPENSINGRINSE189319
48878-0620-3Peridex118 mL in 1 BOTTLERINSE11819
48878-0620-5Peridex473 mL in 1 BOTTLERINSE4738

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
48878-0620-1ML - Milliliter48878-062092ec50f4-5a42-4c30-8fa0-a8171835033e12012-07-24
48878-0620-2ML - Milliliter48878-06208979b721-1391-4fa2-986a-322bfed0be4312016-03-04
48878-0620-3ML - Milliliter48878-0620889428e9-d37f-40fa-b4eb-dd8b1cf918dc12014-06-03
48878-0620-4ML - Milliliter48878-0620effaa17f-09f9-40f7-9dd2-8e3ff98a4c5d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
chlorhexidine gluconateACTIVE INGREDIENTMOR84MUD8EPERIDEX (CHLORHEXIDINE GLUCONATE) RINSE [3M ESPE DENTAL PRODUCTS]10
chlorhexidineACTIVE MOIETYR4KO0DY52LPERIDEX (CHLORHEXIDINE GLUCONATE) RINSE [3M ESPE DENTAL PRODUCTS]10
alcoholINACTIVE INGREDIENT3K9958V90MPERIDEX (CHLORHEXIDINE GLUCONATE) RINSE [3M ESPE DENTAL PRODUCTS]10
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPERIDEX (CHLORHEXIDINE GLUCONATE) RINSE [3M ESPE DENTAL PRODUCTS]10
glycerinINACTIVE INGREDIENTPDC6A3C0OXPERIDEX (CHLORHEXIDINE GLUCONATE) RINSE [3M ESPE DENTAL PRODUCTS]10
saccharin sodiumINACTIVE INGREDIENTSB8ZUX40TYPERIDEX (CHLORHEXIDINE GLUCONATE) RINSE [3M ESPE DENTAL PRODUCTS]10
waterINACTIVE INGREDIENT059QF0KO0RPERIDEX (CHLORHEXIDINE GLUCONATE) RINSE [3M ESPE DENTAL PRODUCTS]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48878-0620PERIDEX (CHLORHEXIDINE GLUCONATE) RINSE [SOLVENTUM US LLC]19Current NDC, Legacy NDC, 3 package rows20240808_3fcd41c4-875a-4e54-b533-261f198011af.zip
48878-0620PERIDEX (CHLORHEXIDINE GLUCONATE) RINSE [SOLVENTUM US LLC]8Current NDC, Legacy NDC, 1 package rows20240808_4d2b43c9-64cb-468f-8541-d8c42aa084c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834127chlorhexidine gluconate 0.12 % Oral RinsePSN3fcd41c4-875a-4e54-b533-261f198011af19
834135Peridex 0.12 % Oral RinsePSN3fcd41c4-875a-4e54-b533-261f198011af19
834135chlorhexidine gluconate 1.2 MG/ML Mouthwash [Peridex]SBD3fcd41c4-875a-4e54-b533-261f198011af19
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCD3fcd41c4-875a-4e54-b533-261f198011af19
834127chlorhexidine gluconate 0.12 % MouthwashSY3fcd41c4-875a-4e54-b533-261f198011af19
834127chlorhexidine gluconate 0.12 % Oral RinseSY3fcd41c4-875a-4e54-b533-261f198011af19
834135Peridex 0.12 % Oral RinseSY3fcd41c4-875a-4e54-b533-261f198011af19
834135Peridex 1.2 MG/ML Oral RinseSY3fcd41c4-875a-4e54-b533-261f198011af19
834127chlorhexidine gluconate 0.12 % Oral RinsePSN4d2b43c9-64cb-468f-8541-d8c42aa084c28
834135Peridex 0.12 % Oral RinsePSN4d2b43c9-64cb-468f-8541-d8c42aa084c28
834135chlorhexidine gluconate 1.2 MG/ML Mouthwash [Peridex]SBD4d2b43c9-64cb-468f-8541-d8c42aa084c28
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCD4d2b43c9-64cb-468f-8541-d8c42aa084c28
834127chlorhexidine gluconate 0.12 % MouthwashSY4d2b43c9-64cb-468f-8541-d8c42aa084c28
834127chlorhexidine gluconate 0.12 % Oral RinseSY4d2b43c9-64cb-468f-8541-d8c42aa084c28
834135Peridex 0.12 % Oral RinseSY4d2b43c9-64cb-468f-8541-d8c42aa084c28
834135Peridex 1.2 MG/ML Oral RinseSY4d2b43c9-64cb-468f-8541-d8c42aa084c28

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
48878-0620-148878062001473 mL in 1 BOTTLE (48878-0620-1) 473 ml1986-08-130000-00-00NoNoCurrent
48878-0620-2488780620021893 mL in 1 BOTTLE, DISPENSING (48878-0620-2) 1893 ml2013-01-160000-00-00NoNoCurrent
48878-0620-348878062003118 mL in 1 BOTTLE (48878-0620-3) 118 ml2013-01-160000-00-00NoNoCurrent
48878-0620-548878062005473 mL in 1 BOTTLE473 mlHistorical