Home NDC 53462-009 Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System
Product NDC 53462-009
11-digit product format 534620009
Labeler code 53462
Product ID 53462-009_8e71bf01-8708-1ddb-e053-2995a90abe6a
Type HUMAN OTC DRUG
Nonproprietary name CHLORHEXIDINE GLUCONATE
Dosage form KIT
Labeler Sage Products, LLC
Application NDA021669
Marketing category NDA
Marketing start 2016-12-28
Marketing end 0000-00-00
Active strength 0
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 38 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 53462-009-24 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 53462-009-24 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 53462-009-24 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 53462-009-24 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 53462-009-24 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 53462-009-24 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 53462-009-24 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53462-009-24 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53462-009-24 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 53462-009-24 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 53462-009-24 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 53462-009-24 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 53462-009-24 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 53462-009-24 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 53462-009-24 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 53462-009-24 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 53462-009-24 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 53462-009-24 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 53462-009-24 8dfbde2a14a4…c9ff85d89658…
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 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 · 41 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 2026-02-19 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…2022-10-28 04:53 UTC 2022-10 N021669-001 CHLORHEXIDINE GLUCONATE 2% CLOTH / TOPICAL RLD, RS 2005-04-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021669-001 CHLORHEXIDINE GLUCONATE 2% CLOTH / TOPICAL RLD, RS 2005-04-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021669-001 CHLORHEXIDINE GLUCONATE 2% CLOTH / TOPICAL RLD, RS 2005-04-25 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 5 · 180 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021669-001 7427574 2026-04-25 Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021669-001 7935093 2027-10-02 U-1022 Drug product 2011-05-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021669-001 7717889 2025-02-27 U-1022 Drug product 2012-05-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021669-001 7427574 2026-04-25 Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021669-001 7935093 2027-10-02 U-1022 Drug product 2011-05-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021669-001 7717889 2025-02-27 U-1022 Drug product 2012-05-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021669-001 7427574 2026-04-25 Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021669-001 7935093 2027-10-02 U-1022 Drug product 2011-05-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021669-001 7717889 2025-02-27 U-1022 Drug product 2012-05-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021669-001 7427574 2026-04-25 Drug product fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021669-001 7935093 2027-10-02 U-1022 Drug product 2011-05-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021669-001 7717889 2025-02-27 U-1022 Drug product 2012-05-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021669-001 7427574 2026-04-25 Drug product b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021669-001 7935093 2027-10-02 U-1022 Drug product 2011-05-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021669-001 7066916 2024-02-17 U-737 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021669-001 7717889 2025-02-27 U-1022 Drug product 2012-05-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021669-001 7427574 2026-04-25 Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021669-001 7935093 2027-10-02 U-1022 Drug product 2011-05-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021669-001 7066916 2024-02-17 U-737 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021669-001 7717889 2025-02-27 U-1022 Drug product 2012-05-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021669-001 7427574 2026-04-25 Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021669-001 7935093 2027-10-02 U-1022 Drug product 2011-05-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021669-001 7066916 2024-02-17 U-737 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021669-001 7717889 2025-02-27 U-1022 Drug product 2012-05-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021669-001 7427574 2026-04-25 Drug product 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021669-001 7935093 2027-10-02 U-1022 Drug product 2011-05-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021669-001 7066916 2024-02-17 U-737 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021669-001 7717889 2025-02-27 U-1022 Drug product 2012-05-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021669-001 7427574 2026-04-25 Drug product d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021669-001 7935093 2027-10-02 U-1022 Drug product 2011-05-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021669-001 7066916 2024-02-17 U-737 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021669-001 7717889 2025-02-27 U-1022 Drug product 2012-05-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021669-001 7427574 2026-04-25 Drug product d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021669-001 7935093 2027-10-02 U-1022 Drug product 2011-05-24 d06236e962d9…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…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53462-009-24 Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System 1 in 1 KIT KIT 1 5 53462-375-60 Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System 7 mL in 1 PACKET RINSE 7 mL 0.5 mg in 1mL 5 53462-705-23 Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System 6 in 1 PACKAGE CLOTH 6 500 mg 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53462-009 SKIN ANTISEPSIS, ORAL CLEANSING AND NASAL ANTISEPSIS SYSTEM (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, LLC] 5 Legacy NDC, 3 package rows 20190725_46f82c35-88bb-4f06-abf4-5250e7173aa6.zip
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 53462-009-24 53462000924 1 in 1 KIT Historical 53462-375-60 53462037560 7 mL in 1 PACKET 7 ml Historical 53462-705-23 53462070523 6 in 1 PACKAGE Historical