Application 021074

Type: NDA
Sponsor: 3M

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AVAGARD	ALCOHOL; CHLORHEXIDINE GLUCONATE	SOLUTION;TOPICAL	61%;1%	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N021074-001	AVAGARD	ALCOHOL; CHLORHEXIDINE GLUCONATE	61%;1%	SOLUTION / TOPICAL		RLD, RS	2001-06-07

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021074-001	AVAGARD	61%;1%	SOLUTION / TOPICAL	RLD, RS	2001-06-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021074-001	AVAGARD	61%;1%	SOLUTION / TOPICAL	RLD, RS	2001-06-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021074-001	AVAGARD	61%;1%	SOLUTION / TOPICAL	RLD, RS	2001-06-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021074-001	AVAGARD	61%;1%	SOLUTION / TOPICAL	RLD, RS	2001-06-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021074-001	AVAGARD	61%;1%	SOLUTION / TOPICAL	RLD, RS	2001-06-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021074-001	AVAGARD	61%;1%	SOLUTION / TOPICAL	RLD, RS	2001-06-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021074-001	AVAGARD	61%;1%	SOLUTION / TOPICAL	RLD, RS	2001-06-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021074-001	AVAGARD	61%;1%	SOLUTION / TOPICAL	RLD, RS	2001-06-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021074-001	AVAGARD	61%;1%	SOLUTION / TOPICAL	RLD, RS	2001-06-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021074-001	AVAGARD	61%;1%	SOLUTION / TOPICAL	RLD, RS	2001-06-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021074-001	AVAGARD	61%;1%	SOLUTION / TOPICAL	RLD, RS	2001-06-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021074-001	AVAGARD	61%;1%	SOLUTION / TOPICAL	RLD, RS	2001-06-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021074-001	AVAGARD	61%;1%	SOLUTION / TOPICAL	RLD, RS	2001-06-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021074-001	AVAGARD	61%;1%	SOLUTION / TOPICAL	RLD, RS	2001-06-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021074-001	AVAGARD	61%;1%	SOLUTION / TOPICAL	RLD, RS	2001-06-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021074-001	AVAGARD	61%;1%	SOLUTION / TOPICAL	RLD, RS	2001-06-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021074-001	AVAGARD	61%;1%	SOLUTION / TOPICAL	RLD, RS	2001-06-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021074-001	AVAGARD	61%;1%	SOLUTION / TOPICAL	RLD, RS	2001-06-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021074-001	AVAGARD	61%;1%	SOLUTION / TOPICAL	RLD, RS	2001-06-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021074-001	AVAGARD	61%;1%	SOLUTION / TOPICAL	RLD, RS	2001-06-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021074-001	AVAGARD	61%;1%	SOLUTION / TOPICAL	RLD, RS	2001-06-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021074-001	AVAGARD	61%;1%	SOLUTION / TOPICAL	RLD, RS	2001-06-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021074-001	AVAGARD	61%;1%	SOLUTION / TOPICAL	RLD, RS	2001-06-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021074-001	AVAGARD	61%;1%	SOLUTION / TOPICAL	RLD, RS	2001-06-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021074-001	AVAGARD	61%;1%	SOLUTION / TOPICAL	RLD, RS	2001-06-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021074-001	AVAGARD	61%;1%	SOLUTION / TOPICAL	RLD, RS	2001-06-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021074-001	AVAGARD	61%;1%	SOLUTION / TOPICAL	RLD, RS	2001-06-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021074-001	AVAGARD	61%;1%	SOLUTION / TOPICAL	RLD, RS	2001-06-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021074-001	AVAGARD	61%;1%	SOLUTION / TOPICAL	RLD, RS	2001-06-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021074-001	AVAGARD	61%;1%	SOLUTION / TOPICAL	RLD, RS	2001-06-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021074-001	AVAGARD	61%;1%	SOLUTION / TOPICAL	RLD, RS	2001-06-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021074-001	AVAGARD	61%;1%	SOLUTION / TOPICAL	RLD, RS	2001-06-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021074-001	AVAGARD	61%;1%	SOLUTION / TOPICAL	RLD, RS	2001-06-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021074-001	AVAGARD	61%;1%	SOLUTION / TOPICAL	RLD, RS	2001-06-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021074-001	AVAGARD	61%;1%	SOLUTION / TOPICAL	RLD, RS	2001-06-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021074-001	AVAGARD	61%;1%	SOLUTION / TOPICAL	RLD, RS	2001-06-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021074-001	AVAGARD	61%;1%	SOLUTION / TOPICAL	RLD, RS	2001-06-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021074-001	AVAGARD	61%;1%	SOLUTION / TOPICAL	RLD, RS	2001-06-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021074-001	AVAGARD	61%;1%	SOLUTION / TOPICAL	RLD, RS	2001-06-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021074-001	AVAGARD	61%;1%	SOLUTION / TOPICAL	RLD, RS	2001-06-07	`e64feba35796…`

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
3M Avagard	CHLORHEXIDINE GLUCONATE AND ALCOHOL	Solventum US LLC	8bf8fe8e-76cb-4eda-a18d-1687050285ae	2026-04-22	Warnings	Exact identifier application applno (NDA): 021074 application number: NDA021074 ndc (product): 17518-051

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17518-051	3M Avagard	Chlorhexidine Gluconate and Alcohol	3M Health Care	NDA	Current
17518-051	3M Avagard	Chlorhexidine Gluconate and Alcohol	3M Company	NDA	Current
17518-051	3M Avagard	Chlorhexidine Gluconate and Alcohol	3M Company	NDA	Current
17518-051	3M Avagard	Chlorhexidine Gluconate and Alcohol	3M Company	NDA	Current
17518-051	3M Avagard	Chlorhexidine Gluconate and Alcohol	3M Health Care	NDA	Current
17518-051	3M Avagard	Chlorhexidine Gluconate and Alcohol	3M Health Care	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
49704	SUPPL	2017-09-08
49697	SUPPL	2017-09-08
45899	SUPPL	2016-11-16
45838	SUPPL	2016-11-08
26647	SUPPL	2015-11-16
36022	SUPPL	2015-11-13
36021	SUPPL	2014-01-14
4221	SUPPL	2013-02-20
4220	SUPPL	2012-06-11
4219	SUPPL	2012-05-21
21417	ORIG	2004-05-27
14293	ORIG	2001-10-02
4218	ORIG	2001-10-02