Home NDC 81657-001-01 Chlorhexidine Gluconate Solution 0.75% Antiseptic
Product NDC 81657-001
Requested package NDC 81657-001-01
11-digit product format 816570001
Labeler code 81657
Product ID 81657-001_c516fa22-f099-5a13-e053-2a95a90adff1
Type HUMAN OTC DRUG
Nonproprietary name Chlorhexidine Gluconate Solution 0.75% Antiseptic
Dosage form SOLUTION
Route TOPICAL
Labeler USA Medical Supply LLC
Application NDA020111
Marketing category NDA
Marketing start 2014-09-30
Marketing end 0000-00-00
Substance CHLORHEXIDINE GLUCONATE
Active strength 1 mg/100mL
NDC exclude flag No
Listing certified through 2022-12-31
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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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 N020111-001 CHLORHEXIDINE GLUCONATE CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11
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 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 cb3db0bc1861…
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 81657-001-01 Chlorhexidine Gluconate Solution 0.75% Antiseptic 118 mL in 1 BOTTLE, PLASTIC SOLUTION 118 1 81657-001-02 Chlorhexidine Gluconate Solution 0.75% Antiseptic 236 mL in 1 BOTTLE, PLASTIC SOLUTION 236 1 81657-001-03 Chlorhexidine Gluconate Solution 0.75% Antiseptic 3785 mL in 1 JUG SOLUTION 3785 1 81657-001-04 Chlorhexidine Gluconate Solution 0.75% Antiseptic 236 mL in 1 BOTTLE, PUMP SOLUTION 236 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81657-001 CHLORHEXIDINE GLUCONATE SOLUTION 0.75% ANTISEPTIC SOLUTION [USA MEDICAL SUPPLY LLC] 1 Legacy NDC, 4 package rows 20210620_c516ebf4-f3b8-6039-e053-2a95a90a4184.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 81657-001-01 81657000101 118 mL in 1 BOTTLE, PLASTIC (81657-001-01) 118 ml 2014-09-30 0000-00-00 No No Current