Home NDC 0116-0620 Peridex
Product NDC 0116-0620
11-digit product format 001160620
Labeler code 0116
Product ID 0116-0620_f0711fbf-b273-0705-e053-2a95a90a131a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name chlorhexidine gluconate
Dosage form RINSE
Route ORAL
Labeler Xttrium Laboratories, Inc.
Application NDA019028
Marketing category NDA
Marketing start 1986-08-13
Marketing end 0000-00-00
Substance CHLORHEXIDINE GLUCONATE
Active strength 1 mg/mL
Pharmacologic classes Decreased Cell Wall Integrity [PE]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019028-001 PERIDEX CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT RLD, RS 1986-08-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N019028-001 AT
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019028-001 PERIDEX 0.12% SOLUTION / DENTAL AT RLD, RS 1986-08-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019028-001 PERIDEX 0.12% SOLUTION / DENTAL AT RLD, RS 1986-08-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019028-001 PERIDEX 0.12% SOLUTION / DENTAL AT RLD, RS 1986-08-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019028-001 PERIDEX 0.12% SOLUTION / DENTAL AT RLD, RS 1986-08-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019028-001 PERIDEX 0.12% SOLUTION / DENTAL AT RLD, RS 1986-08-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019028-001 PERIDEX 0.12% SOLUTION / DENTAL AT RLD, RS 1986-08-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019028-001 PERIDEX 0.12% SOLUTION / DENTAL AT RLD, RS 1986-08-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019028-001 PERIDEX 0.12% SOLUTION / DENTAL AT RLD, RS 1986-08-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019028-001 PERIDEX 0.12% SOLUTION / DENTAL AT RLD, RS 1986-08-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N019028-001 PERIDEX 0.12% SOLUTION / DENTAL AT RLD, RS 1986-08-13 cb3db0bc1861…2026-08-01 22:54:32 2026-06 N019028-001 PERIDEX 0.12% SOLUTION / DENTAL AT RLD, RS 1986-08-13 a50c72e98297…
Observed Orange Book normalized TE history# 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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Peridex CHLORHEXIDINE GLUCONATE Solventum US LLC 3fcd41c4-875a-4e54-b533-261f198011af 2024-08-01 Warnings, Adverse reactions Exact identifier application applno (NDA): 019028 application number: NDA019028
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0116-0620 PERIDEX (CHLORHEXIDINE GLUCONATE) RINSE [XTTRIUM LABORATORIES, INC.] 16 Legacy NDC 20221223_4703eff7-b30b-5a7d-e054-00144ff88e88.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0116-0620-01 00116062001 473 mL in 1 BOTTLE (0116-0620-01) 473 ml 1986-08-13 0000-00-00 No No Current 0116-0620-02 00116062002 1893 mL in 1 BOTTLE, DISPENSING (0116-0620-02) 1893 ml 2013-01-16 0000-00-00 No No Current 0116-0620-03 00116062003 118 mL in 1 BOTTLE (0116-0620-03) 118 ml 2013-01-16 0000-00-00 No No Current