Hibiclens for Georgia Pacific

Product NDC: 54622-575
11-digit product format: 546220575
Labeler code: 54622
Product ID: 54622-575_efe2af77-c6c9-27e3-e053-2a95a90ad1ec
Type: HUMAN OTC DRUG
Nonproprietary name: Chlorhexidine Gluconate
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Georgia-Pacific Consumer Products LP
Application: NDA017768
Marketing category: NDA
Marketing start: 2022-03-01
Marketing end: 0000-00-00
Substance: CHLORHEXIDINE GLUCONATE
Active strength: 4 g/100mL
Pharmacologic classes: Decreased Cell Wall Integrity [PE]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	54622-575		I	Inactivated by FDA		2026-08-17
excluded package	package	54622-575	54622-575-73	I	Inactivated by FDA		2026-08-17

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 · 30 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	54622-575-73	`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	54622-575-73	`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	54622-575-73	`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	54622-575-73	`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	54622-575-73	`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	54622-575-73	`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	54622-575-73	`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	54622-575-73	`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	54622-575-73	`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	54622-575-73	`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	54622-575-73	`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	54622-575-73	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	54622-575-73	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	54622-575-73	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	54622-575-73	`1332a3947898…`	`d4bfe170f9cd…`

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
N017768-001	HIBICLENS	CHLORHEXIDINE GLUCONATE	4%	SOLUTION / TOPICAL		RLD, RS, Approved before 1982

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	Source SHA-256
2026-08-18 06:07:40	2026-07	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`e64feba35796…`

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, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54622-575-73	2024-01-30	C162847	48780-1	1030e365-5080-111a-e063-dadaa90a10e2	Hibiclens for Georgia Pacific

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54622-575-73	Hibiclens for Georgia Pacific	1200 mL in 1 BOTTLE, DISPENSING	SOLUTION	1200		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54622-575	HIBICLENS FOR GEORGIA PACIFIC (CHLORHEXIDINE GLUCONATE) SOLUTION [GEORGIA-PACIFIC CONSUMER PRODUCTS LP]	2	Legacy NDC, 1 package rows	20221217_d9a397a0-9484-34ef-e053-2995a90a642b.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hibiclens	CHLORHEXIDINE GLUCONATE	Molnlycke Health Care	29b547bf-c08e-14c2-e054-00144ff88e88	2024-12-23	Warnings	Exact identifier application applno (NDA): 017768 application number: NDA017768
Hibiclens	CHLORHEXIDINE GLUCONATE	Molnlycke Health Care	4275eb53-1a7e-4a91-aac1-1085f40fac88	2024-12-23	Warnings	Exact identifier application applno (NDA): 017768 application number: NDA017768
Hibiclens	CHLORHEXIDINE GLUCONATE	Molnlycke Health Care	8b37a721-79bb-4051-95a7-fcb4edebfcb7	2024-12-23	Warnings	Exact identifier application applno (NDA): 017768 application number: NDA017768
Hibiclens	CHLORHEXIDINE GLUCONATE	Asclemed USA, Inc.	c7363108-0b4e-4d8a-9ec8-ea048604ecb2	2024-10-05	Warnings	Exact identifier application applno (NDA): 017768 application number: NDA017768

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
211365	chlorhexidine gluconate 4 % Medicated Liquid Soap	PSN	d9a397a0-9484-34ef-e053-2995a90a642b	2
834167	HIBICLENS 4 % Medicated Liquid Soap	PSN	d9a397a0-9484-34ef-e053-2995a90a642b	2
834167	chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap [Hibiclens]	SBD	d9a397a0-9484-34ef-e053-2995a90a642b	2
211365	chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap	SCD	d9a397a0-9484-34ef-e053-2995a90a642b	2
211365	chlorhexidine gluconate 4 % Medicated Liquid Soap	SY	d9a397a0-9484-34ef-e053-2995a90a642b	2
211365	chlorhexidine gluconate 4 % Medicated Surgical Scrub	SY	d9a397a0-9484-34ef-e053-2995a90a642b	2
834167	Hibiclens 4 % Medicated Liquid Soap	SY	d9a397a0-9484-34ef-e053-2995a90a642b	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54622-575-73	54622057573	1200 mL in 1 BOTTLE, DISPENSING (54622-575-73)	1200 ml	2022-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hibiclens for Georgia Pacific	Georgia-Pacific Consumer Products LP	2022-12-15	HUMAN OTC DRUG LABEL	2