Home Applications 021669 Application 021669
Type NDA
Sponsor SAGE PRODS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CHLORHEXIDINE GLUCONATE CHLORHEXIDINE GLUCONATE CLOTH;TOPICAL 2% Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 N021669-001 CHLORHEXIDINE GLUCONATE CHLORHEXIDINE GLUCONATE 2% CLOTH / TOPICAL RLD, RS 2005-04-25
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021669-001 7427574 2026-04-25 Drug product N021669-001 7935093 2027-10-02 U-1022 Drug product 2011-05-24
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.
Product history page 1 of 2 · 44 observed 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 2026-10-15 13:18:30 2026-09 N021669-001 CHLORHEXIDINE GLUCONATE 2% CLOTH / TOPICAL RLD, RS 2005-04-25 c2088c7a36db…2026-09-14 22:38:34 2026-08 N021669-001 CHLORHEXIDINE GLUCONATE 2% CLOTH / TOPICAL RLD, RS 2005-04-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021669-001 CHLORHEXIDINE GLUCONATE 2% CLOTH / TOPICAL RLD, RS 2005-04-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021669-001 CHLORHEXIDINE GLUCONATE 2% CLOTH / TOPICAL RLD, RS 2005-04-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021669-001 CHLORHEXIDINE GLUCONATE 2% CLOTH / TOPICAL RLD, RS 2005-04-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021669-001 CHLORHEXIDINE GLUCONATE 2% CLOTH / TOPICAL RLD, RS 2005-04-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021669-001 CHLORHEXIDINE GLUCONATE 2% CLOTH / TOPICAL RLD, RS 2005-04-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021669-001 CHLORHEXIDINE GLUCONATE 2% CLOTH / TOPICAL RLD, RS 2005-04-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021669-001 CHLORHEXIDINE GLUCONATE 2% CLOTH / TOPICAL RLD, RS 2005-04-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021669-001 CHLORHEXIDINE GLUCONATE 2% CLOTH / TOPICAL RLD, RS 2005-04-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021669-001 CHLORHEXIDINE GLUCONATE 2% CLOTH / TOPICAL RLD, RS 2005-04-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021669-001 CHLORHEXIDINE GLUCONATE 2% CLOTH / TOPICAL RLD, RS 2005-04-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021669-001 CHLORHEXIDINE GLUCONATE 2% CLOTH / TOPICAL RLD, RS 2005-04-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021669-001 CHLORHEXIDINE GLUCONATE 2% CLOTH / TOPICAL RLD, RS 2005-04-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021669-001 CHLORHEXIDINE GLUCONATE 2% CLOTH / TOPICAL RLD, RS 2005-04-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021669-001 CHLORHEXIDINE GLUCONATE 2% CLOTH / TOPICAL RLD, RS 2005-04-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021669-001 CHLORHEXIDINE GLUCONATE 2% CLOTH / TOPICAL RLD, RS 2005-04-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021669-001 CHLORHEXIDINE GLUCONATE 2% CLOTH / TOPICAL RLD, RS 2005-04-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021669-001 CHLORHEXIDINE GLUCONATE 2% CLOTH / TOPICAL RLD, RS 2005-04-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021669-001 CHLORHEXIDINE GLUCONATE 2% CLOTH / TOPICAL RLD, RS 2005-04-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021669-001 CHLORHEXIDINE GLUCONATE 2% CLOTH / TOPICAL RLD, RS 2005-04-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021669-001 CHLORHEXIDINE GLUCONATE 2% CLOTH / TOPICAL RLD, RS 2005-04-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021669-001 CHLORHEXIDINE GLUCONATE 2% CLOTH / TOPICAL RLD, RS 2005-04-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021669-001 CHLORHEXIDINE GLUCONATE 2% CLOTH / TOPICAL RLD, RS 2005-04-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021669-001 CHLORHEXIDINE GLUCONATE 2% CLOTH / TOPICAL RLD, RS 2005-04-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021669-001 CHLORHEXIDINE GLUCONATE 2% CLOTH / TOPICAL RLD, RS 2005-04-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021669-001 CHLORHEXIDINE GLUCONATE 2% CLOTH / TOPICAL RLD, RS 2005-04-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021669-001 CHLORHEXIDINE GLUCONATE 2% CLOTH / TOPICAL RLD, RS 2005-04-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021669-001 CHLORHEXIDINE GLUCONATE 2% CLOTH / TOPICAL RLD, RS 2005-04-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021669-001 CHLORHEXIDINE GLUCONATE 2% CLOTH / TOPICAL RLD, RS 2005-04-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021669-001 CHLORHEXIDINE GLUCONATE 2% CLOTH / TOPICAL RLD, RS 2005-04-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021669-001 CHLORHEXIDINE GLUCONATE 2% CLOTH / TOPICAL RLD, RS 2005-04-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021669-001 CHLORHEXIDINE GLUCONATE 2% CLOTH / TOPICAL RLD, RS 2005-04-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021669-001 CHLORHEXIDINE GLUCONATE 2% CLOTH / TOPICAL RLD, RS 2005-04-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021669-001 CHLORHEXIDINE GLUCONATE 2% CLOTH / TOPICAL RLD, RS 2005-04-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021669-001 CHLORHEXIDINE GLUCONATE 2% CLOTH / TOPICAL RLD, RS 2005-04-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021669-001 CHLORHEXIDINE GLUCONATE 2% CLOTH / TOPICAL RLD, RS 2005-04-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021669-001 CHLORHEXIDINE GLUCONATE 2% CLOTH / TOPICAL RLD, RS 2005-04-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021669-001 CHLORHEXIDINE GLUCONATE 2% CLOTH / TOPICAL RLD, RS 2005-04-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021669-001 CHLORHEXIDINE GLUCONATE 2% CLOTH / TOPICAL RLD, RS 2005-04-25 3a93d1ddd44b…
Observed Orange Book patent history# Patent history page 2 of 5 · 186 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021669-001 7066916 2024-02-17 U-737 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021669-001 7717889 2025-02-27 U-1022 Drug product 2012-05-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021669-001 7427574 2026-04-25 Drug product 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021669-001 7935093 2027-10-02 U-1022 Drug product 2011-05-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021669-001 7066916 2024-02-17 U-737 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021669-001 7717889 2025-02-27 U-1022 Drug product 2012-05-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021669-001 7427574 2026-04-25 Drug product 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021669-001 7935093 2027-10-02 U-1022 Drug product 2011-05-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021669-001 7066916 2024-02-17 U-737 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021669-001 7717889 2025-02-27 U-1022 Drug product 2012-05-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021669-001 7427574 2026-04-25 Drug product 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021669-001 7935093 2027-10-02 U-1022 Drug product 2011-05-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021669-001 7066916 2024-02-17 U-737 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021669-001 7717889 2025-02-27 U-1022 Drug product 2012-05-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021669-001 7427574 2026-04-25 Drug product 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021669-001 7935093 2027-10-02 U-1022 Drug product 2011-05-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021669-001 7595021 2023-05-12 U-1022 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021669-001 7066916 2024-02-17 U-737 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021669-001 7717889 2025-02-27 U-1022 Drug product 2012-05-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021669-001 7427574 2026-04-25 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021669-001 7935093 2027-10-02 U-1022 Drug product 2011-05-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021669-001 7595021 2023-05-12 U-1022 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021669-001 7066916 2024-02-17 U-737 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021669-001 7717889 2025-02-27 U-1022 Drug product 2012-05-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021669-001 7427574 2026-04-25 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021669-001 7935093 2027-10-02 U-1022 Drug product 2011-05-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021669-001 7595021 2023-05-12 U-1022 Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021669-001 7066916 2024-02-17 U-737 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021669-001 7717889 2025-02-27 U-1022 Drug product 2012-05-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021669-001 7427574 2026-04-25 Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021669-001 7935093 2027-10-02 U-1022 Drug product 2011-05-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021669-001 7595021 2023-05-12 U-1022 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021669-001 7066916 2024-02-17 U-737 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021669-001 7717889 2025-02-27 U-1022 Drug product 2012-05-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021669-001 7427574 2026-04-25 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021669-001 7935093 2027-10-02 U-1022 Drug product 2011-05-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021669-001 7595021 2023-05-12 U-1022 Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021669-001 7066916 2024-02-17 U-737 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021669-001 7717889 2025-02-27 U-1022 Drug product 2012-05-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021669-001 7427574 2026-04-25 Drug product bb7c543d1eb4…
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 · 1 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 53462-007 Skin antisepsis, oral cleansing, nasal antisepsis CHLORHEXIDINE GLUCONATE Sage Products, Inc. NDA Current 53462-007 Skin antisepsis, oral cleansing, nasal antisepsis CHLORHEXIDINE GLUCONATE Sage Products LLC NDA Current 53462-008 Skin antisepsis, oral cleansing, nasal antisepsis CHLORHEXIDINE GLUCONATE Sage Products, Inc. NDA Current 53462-009 Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System CHLORHEXIDINE GLUCONATE Sage Products, LLC NDA Current 53462-009 Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System CHLORHEXIDINE GLUCONATE Sage Products, LLC NDA Current 53462-110 Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System CHLORHEXIDINE GLUCONATE Sage Products, LLC NDA Current 53462-705 CHLORHEXIDINE GLUCONATE CHLORHEXIDINE GLUCONATE Sage Products LLC NDA Current 53462-705 CHLORHEXIDINE GLUCONATE CHLORHEXIDINE GLUCONATE Sage Products LLC NDA Current 53462-705 CHLORHEXIDINE GLUCONATE CHLORHEXIDINE GLUCONATE Sage Products LLC NDA Current 53462-705 Chlorhexidine Gluconate Chlorhexidine Gluconate Sage Products LLC NDA Current 86994-001 LARA MED Antibacterial Wet Wipes CHLORHEXIDINE GLUCONATE LARA KOZMETIK HIJYENIK URUNLERI SANAYI VE DIS TICARET ANONIM SIRKETI NDA Current 86994-001 LARA MED Antibacterial Wet Wipes CHLORHEXIDINE GLUCONATE LARA KOZMETIK HIJYENIK URUNLERI SANAYI VE DIS TICARET ANONIM SIRKETI NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 49705 SUPPL 2017-09-08 49699 SUPPL 2017-09-08 15951 SUPPL 2014-07-31 5952 SUPPL 2014-06-25 5951 SUPPL 2012-05-23 21773 SUPPL 2011-01-07 21772 ORIG 2007-01-22 28340 SUPPL 2006-08-21 15950 SUPPL 2006-08-18 28339 SUPPL 2006-01-20 37428 ORIG 2005-04-28 5950 ORIG 2005-04-28