Chlorhexidine Gluconate Solution 0.75% Antiseptic

Product NDC: 81657-001
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	81657-001		I	Inactivated by FDA	2026-08-10
excluded package	package	81657-001	81657-001-01	I	Inactivated by FDA	2026-08-10
excluded package	package	81657-001	81657-001-02	I	Inactivated by FDA	2026-08-10
excluded package	package	81657-001	81657-001-03	I	Inactivated by FDA	2026-08-10
excluded package	package	81657-001	81657-001-04	I	Inactivated by FDA	2026-08-10

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 2 · 75 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	81657-001-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	81657-001-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	81657-001-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	81657-001-03	`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	81657-001-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	81657-001-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	81657-001-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	81657-001-03	`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	81657-001-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	81657-001-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	81657-001-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	81657-001-03	`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	81657-001-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	81657-001-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	81657-001-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	81657-001-03	`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	81657-001-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	81657-001-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	81657-001-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	81657-001-03	`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	81657-001-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	81657-001-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	81657-001-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	81657-001-03	`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	81657-001-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	81657-001-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	81657-001-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	81657-001-03	`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	81657-001-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	81657-001-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	81657-001-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	81657-001-03	`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	81657-001-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	81657-001-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	81657-001-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	81657-001-03	`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	81657-001-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	81657-001-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	81657-001-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	81657-001-03	`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	81657-001-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	81657-001-04	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	81657-001-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	81657-001-03	`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	81657-001-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	81657-001-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	81657-001-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	81657-001-03	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	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#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68	Product name	1	20160303

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
81657-001-01	Drug Facts
81657-001-02	Drug Facts
81657-001-03	Drug Facts
81657-001-04	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chlorhexidine Gluconate Solution 0.75% Antiseptic	CHLORHEXIDINE GLUCONATE SOLUTION 0.75% ANTISEPTIC	Bajaj Medical, LLC	014a5f36-0396-498b-901f-9a86df4e11fe	2022-12-26	Warnings	Exact identifier application applno (NDA): 020111 application number: NDA020111

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
MOR84MUD8E	CHLORHEXIDINE GLUCONATE	18472-51-0	CHLORHEXIDINE GLUCONATE

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
81657-001-02	81657000102	236 mL in 1 BOTTLE, PLASTIC (81657-001-02)	236 ml	2014-09-30	0000-00-00	No	No	Current
81657-001-03	81657000103	3785 mL in 1 JUG (81657-001-03)	3785 ml	2014-09-30	0000-00-00	No	No	Current
81657-001-04	81657000104	236 mL in 1 BOTTLE, PUMP (81657-001-04)	236 ml	2017-10-12	0000-00-00	No	No	Current