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	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 4 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
2019-07-19 19:46 UTC	2019-07	N021669-001	7935093	2027-10-02	U-1022	Drug product	2011-05-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021669-001	7066916	2024-02-17	U-737			`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021669-001	7717889	2025-02-27	U-1022	Drug product	2012-05-25	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021669-001	7427574	2026-04-25		Drug product		`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021669-001	7935093	2027-10-02	U-1022	Drug product	2011-05-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021669-001	7066916	2024-02-17	U-737			`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N021669-001	7717889	2025-02-27	U-1022	Drug product	2012-05-25	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N021669-001	7427574	2026-04-25		Drug product		`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N021669-001	7935093	2027-10-02	U-1022	Drug product	2011-05-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021669-001	7595021	2023-05-12	U-1022	Drug product		`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021669-001	7066916	2024-02-17	U-737			`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021669-001	7717889	2025-02-27	U-1022	Drug product	2012-05-25	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021669-001	7427574	2026-04-25		Drug product		`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021669-001	7935093	2027-10-02	U-1022	Drug product	2011-05-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021669-001	7595021	2023-05-12	U-1022	Drug product		`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021669-001	7066916	2024-02-17	U-737			`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021669-001	7717889	2025-02-27	U-1022	Drug product	2012-05-25	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021669-001	7427574	2026-04-25		Drug product		`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021669-001	7935093	2027-10-02	U-1022	Drug product	2011-05-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021669-001	7595021	2023-05-12	U-1022	Drug product		`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021669-001	7066916	2024-02-17	U-737			`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021669-001	7717889	2025-02-27	U-1022	Drug product	2012-05-25	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021669-001	7427574	2026-04-25		Drug product		`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021669-001	7935093	2027-10-02	U-1022	Drug product	2011-05-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021669-001	7595021	2023-05-12	U-1022	Drug product		`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021669-001	7066916	2024-02-17	U-737			`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021669-001	7717889	2025-02-27	U-1022	Drug product	2012-05-25	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021669-001	7427574	2026-04-25		Drug product		`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021669-001	7935093	2027-10-02	U-1022	Drug product	2011-05-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021669-001	7595021	2023-05-12	U-1022	Drug product		`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021669-001	7066916	2024-02-17	U-737			`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021669-001	7717889	2025-02-27	U-1022	Drug product	2012-05-25	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021669-001	7427574	2026-04-25		Drug product		`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021669-001	7935093	2027-10-02	U-1022	Drug product	2011-05-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021669-001	7595021	2023-05-12	U-1022	Drug product		`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N021669-001	7066916	2024-02-17	U-737			`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N021669-001	7717889	2025-02-27	U-1022	Drug product	2012-05-25	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N021669-001	7427574	2026-04-25		Drug product		`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N021669-001	7935093	2027-10-02	U-1022	Drug product	2011-05-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021669-001	7595021	2023-05-12	U-1022	Drug product		`3bdfa0b2c4d7…`

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	CHLORHEXIDINE GLUCONATE	Sage Products LLC	bdb6a012-37e5-4664-84a3-134bea284744	2026-06-16	Warnings	Exact identifier application applno (NDA): 021669 application number: NDA021669 ndc (product): 53462-705

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