Skin antisepsis, oral cleansing, nasal antisepsis

Product NDC: 53462-008
11-digit product format: 534620008
Labeler code: 53462
Product ID: 53462-008_d36bf0aa-9dec-3328-cab8-8fc6748dafb3
Type: HUMAN OTC DRUG
Nonproprietary name: CHLORHEXIDINE GLUCONATE
Dosage form: KIT
Labeler: Sage Products, Inc.
Application: NDA021669
Marketing category: NDA
Marketing start: 2012-02-06
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53462-008		I	Inactivated by FDA		2026-08-10
excluded package	package	53462-008	53462-008-28	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 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53462-008-28	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53462-008-28	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53462-008-28	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53462-008-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53462-008-28	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53462-008-28	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53462-008-28	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53462-008-28	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53462-008-28	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53462-008-28	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53462-008-28	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53462-008-28	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53462-008-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53462-008-28	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53462-008-28	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53462-008-28	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53462-008-28	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53462-008-28	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53462-008-28	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53462-008-28	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53462-008-28	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	53462-008-28	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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	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#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
5f30b278-5791-4113-8781-878a9221ef8a	Product name	2	20230125
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
2a70c781-a755-4d76-b20a-a958acfbdcdc	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
304592ef-4a8a-4c22-8e8c-af73aa3d60e5	Product name	1	20180703
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22	Product name	1	20180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5c	Product name	1	20180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896	Product name	1	20170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99	Product name	1	20170309
bb6d6c68-649d-4e6d-a1f6-603d969c8f68	Product name	1	20160303
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8c	Product name	1	20150421
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53462-008-28	2020-01-31	C162847	48780-1	9d75b9d0-6748-f424-e053-dadaa90a57ce	2% Chlorhexidine Gluconate Cloth and 3M Skin and Nasal Antiseptic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
17518-060-04	Skin antisepsis, oral cleansing, nasal antisepsis	4 mL in 1 BOTTLE	SOLUTION	4 mL	5 mg in 1mL	1
53462-008-28	Skin antisepsis, oral cleansing, nasal antisepsis	1 in 1 KIT	KIT	1		1
53462-705-23	Skin antisepsis, oral cleansing, nasal antisepsis	6 in 1 PACKAGE	CLOTH	6	500 mg	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
chlorhexidine gluconate	ACTIVE INGREDIENT	MOR84MUD8E	SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]	1
POVIDONE-IODINE	ACTIVE INGREDIENT	85H0HZU99M	SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]	1
chlorhexidine	ACTIVE MOIETY	R4KO0DY52L	SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]	1
IODINE	ACTIVE MOIETY	9679TC07X4	SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]	1
aloe vera leaf	INACTIVE INGREDIENT	ZY81Z83H0X	SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]	1
dimethicone 350	INACTIVE INGREDIENT	2Y53S6ATLU	SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]	1
gluconolactone	INACTIVE INGREDIENT	WQ29KQ9POT	SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]	1
LACTIC ACID	INACTIVE INGREDIENT	33X04XA5AT	SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]	1
LAURAMIDOPROPYLAMINE OXIDE	INACTIVE INGREDIENT	I6KX160QTV	SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]	1
MALIC ACID	INACTIVE INGREDIENT	817L1N4CKP	SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]	1
nonoxynol-9	INACTIVE INGREDIENT	48Q180SH9T	SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]	1
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]	1
polysorbate 20	INACTIVE INGREDIENT	7T1F30V5YH	SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]	1
SODIUM IODIDE	INACTIVE INGREDIENT	F5WR8N145C	SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]	1
XYLITOL	INACTIVE INGREDIENT	VCQ006KQ1E	SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53462-008	SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]	1	Legacy NDC, 3 package rows	20121026_d36bf0aa-9dec-3328-cab8-8fc6748dafb3.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	CHLORHEXIDINE GLUCONATE	Sage Products LLC	bdb6a012-37e5-4664-84a3-134bea284744	2026-06-16	Warnings	Exact identifier application applno (NDA): 021669 application number: NDA021669

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
846127	chlorhexidine gluconate 2 % Medicated Pad	PSN	d36bf0aa-9dec-3328-cab8-8fc6748dafb3	1
252965	povidone-iodine 5 % Topical Solution	PSN	d36bf0aa-9dec-3328-cab8-8fc6748dafb3	1
846127	chlorhexidine gluconate 20 MG/ML Medicated Pad	SCD	d36bf0aa-9dec-3328-cab8-8fc6748dafb3	1
252965	povidone-iodine 50 MG/ML Topical Solution	SCD	d36bf0aa-9dec-3328-cab8-8fc6748dafb3	1
846127	chlorhexidine gluconate 2 % Medicated Pad	SY	d36bf0aa-9dec-3328-cab8-8fc6748dafb3	1
252965	povidone-iodine 5 % (titratable iodine 0.5 % ) Topical Solution	SY	d36bf0aa-9dec-3328-cab8-8fc6748dafb3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
17518-060-04	17518006004	4 mL in 1 BOTTLE	4 ml	Historical
53462-008-28	53462000828	1 in 1 KIT		Historical
53462-705-23	53462070523	6 in 1 PACKAGE		Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
2% Chlorhexidine Gluconate Cloth and 3M Skin and Nasal Antiseptic	Sage Products, Inc. \| 3M ESPE Dental Products \| 3M Health Care LTD	2012-10-22	HUMAN OTC DRUG LABEL	1