FDA.reportPublic FDA data

Application 019028

Type
NDA
Sponsor
3M

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PERIDEXCHLORHEXIDINE GLUCONATESOLUTION;DENTAL0.12%YesYes

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Major Oral Rinse0.12% CHLORHEXIDINE GLUCONATEMajor Pharmaceuticalsb48e69dc-0913-423f-e053-2a95a90a53df2025-12-03Warnings, Adverse reactionsExact identifier
ndc (product): 0904-7035
PeridexCHLORHEXIDINE GLUCONATESolventum US LLC3fcd41c4-875a-4e54-b533-261f198011af2024-08-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 019028
application number: NDA019028
ndc (product): 48878-0620
Sky Oral RinseCHLORHEXIDINE GLUCONATEMcKessonb479c166-899b-0565-e053-2995a90a20942022-09-26Warnings, Adverse reactionsExact identifier
ndc (product): 63739-052

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0116-0620Peridexchlorhexidine gluconateXttrium Laboratories, Inc.NDACurrent
0116-0620Peridexchlorhexidine gluconateXttrium Laboratories, Inc.NDACurrent
0116-0620Peridexchlorhexidine gluconateXttrium Laboratories, Inc.NDACurrent
0116-0620Peridexchlorhexidine gluconateXttrium Laboratories, Inc.NDACurrent
0904-7035Major Oral Rinse0.12% Chlorhexidine GluconateMajor PharmaceuticalsNDACurrent
48878-0620Peridexchlorhexidine gluconate3M ESPE Dental ProductsNDACurrent
48878-0620Peridexchlorhexidine gluconate3M ESPE Dental ProductsNDACurrent
48878-0620Peridexchlorhexidine gluconate3M ESPE Dental ProductsNDACurrent
48878-0620Peridexchlorhexidine gluconate3M ESPE Dental ProductsNDACurrent
63739-052Sky Oral RinseChlorhexidine GluconateMcKessonNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
11418SUPPL2013-01-22
1208SUPPL2013-01-22
11419SUPPL2013-01-14
16177SUPPL2010-10-04