Cardinal Health Antiseptic Skin Cleanser

Product NDC: 63517-113
Requested package NDC: 63517-113-04
11-digit product format: 635170113
Labeler code: 63517
Product ID: 63517-113_8e6033b2-d7e7-28bf-e053-2a95a90af8b1
Type: HUMAN OTC DRUG
Nonproprietary name: CHLORHEXIDINE GLUCONATE 2%
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Cardinal Health
Application: NDA019422
Marketing category: NDA
Marketing start: 2015-05-01
Marketing end: 0000-00-00
Substance: CHLORHEXIDINE GLUCONATE
Active strength: 2 g/100mL
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63517-113	63517-113-04	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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`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
N019422-001	DYNA-HEX 2	CHLORHEXIDINE GLUCONATE	2%	SOLUTION / TOPICAL		RLD, RS	1985-12-17

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	N019422-001	DYNA-HEX 2	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`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, Related label table
NDC	Related label
63517-113-04	2% Cardinal Health
63517-113-08	2% Cardinal Health
63517-113-16	2% Cardinal Health
63517-113-32	2% Cardinal Health

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63517-113-04	Cardinal Health Antiseptic Skin Cleanser	118 mL in 1 BOTTLE, PLASTIC	SOLUTION	118	9
63517-113-08	Cardinal Health Antiseptic Skin Cleanser	237 mL in 1 BOTTLE, PLASTIC	SOLUTION	237	9
63517-113-16	Cardinal Health Antiseptic Skin Cleanser	473 mL in 1 BOTTLE, PLASTIC	SOLUTION	473	9
63517-113-32	Cardinal Health Antiseptic Skin Cleanser	946 mL in 1 BOTTLE, PLASTIC	SOLUTION	946	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63517-113-04	ML - Milliliter	63517-113	9474ef15-5a37-44dc-ac9b-5405efd0df06	1	2024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63517-113	CARDINAL HEALTH ANTISEPTIC SKIN CLEANSER (CHLORHEXIDINE GLUCONATE 2%) SOLUTION [CARDINAL HEALTH]	9	Legacy NDC, 4 package rows	20190724_2dc7bdc7-5d78-57ee-e054-00144ff8d46c.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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DYNA-HEX 2	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	6cc89ac1-baef-40bb-85a3-d9ae9e3e7a63	2026-04-27	Warnings	Exact identifier application applno (NDA): 019422 application number: NDA019422
Bactoshield CHG	CHLORHEXIDINE GLUCONATE 2%	Xttrium Laboratories, Inc.	edfd2be7-b14b-7bd1-e053-2a95a90aa668	2025-12-08	Warnings	Exact identifier application applno (NDA): 019422 application number: NDA019422
foaming hand wash	CHLORHEXIDINE GLUCONATE	Medline Industries, LP	9b926809-65e9-4e5b-e053-2995a90add10	2025-09-08	Warnings	Exact identifier application applno (NDA): 019422 application number: NDA019422
Provon Antimicrobial Foam Handwash	CHLORHEXIDINE GLUCONATE 2%	Xttrium Laboratories, Inc.	46dd136c-d569-0450-e054-00144ff8d46c	2025-04-30	Warnings	Exact identifier application applno (NDA): 019422 application number: NDA019422
DYNA-HEX 2	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	6e5f9616-ddf5-19c4-e053-2991aa0a372a	2025-04-30	Warnings	Exact identifier application applno (NDA): 019422 application number: NDA019422
Dyna-Hex 2	CHLORHEXIDINE GLUCONATE 2%	Xttrium Laboratories, Inc.	0c808ebd-1bf7-175d-e063-6294a90ae7df	2025-04-30	Warnings	Exact identifier application applno (NDA): 019422 application number: NDA019422
Purell Antimicrobial Foam	CHLORHEXIDINE GLUCONATE 2% SOLUTION	GOJO Industries, Inc.	6c7e63c2-428b-2be2-e053-2a91aa0a6af3	2024-12-21	Warnings	Exact identifier application applno (NDA): 019422 application number: NDA019422
Provon Antimicrobial Foam Handwash	CHLORHEXIDINE GLUCONATE 2%	Gojo Industries, Inc.	365c3ac6-6c1f-594b-e054-00144ff88e88	2022-12-20	Warnings	Exact identifier application applno (NDA): 019422 application number: NDA019422
Bactoshield CHG Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	SC Johnson Professional USA, Inc.	46084e90-6ffa-4e1a-a8ff-1c1b1484fe88	2022-11-28	Warnings	Exact identifier application applno (NDA): 019422 application number: NDA019422
Dyna-Hex 2	CHLORHEXIDINE GLUCONATE 2%	Xttrium Laboratories, Inc.	36e6abcb-d792-3ef4-e054-00144ff8d46c	2020-10-13	Warnings	Exact identifier application applno (NDA): 019422 application number: NDA019422
Provon Antimicrobial Foam Handwash	CHLORHEXIDINE GLUCONATE 2%	Gojo Industries, Inc.	36803a5b-3075-5d5b-e054-00144ff8d46c	2019-06-19	Warnings	Exact identifier application applno (NDA): 019422 application number: NDA019422
Antimicrobial Skin Cleanser	CHLORHEXIDINE GLUCONATE 2% SOLUTION	Gojo Industries, Inc.	759beac3-6fc8-40c6-e053-2a91aa0aab57	2019-06-18	Warnings	Exact identifier application applno (NDA): 019422 application number: NDA019422
Purell Antimicrobial Foam	CHLORHEXIDINE GLUCONATE 2% SOLUTION	GOJO Industries, Inc.	6e0f3d2f-7834-68a0-e053-2991aa0ab453	2019-06-18	Warnings	Exact identifier application applno (NDA): 019422 application number: NDA019422
Antimicrobial Foam Handwash	CHLORHEXIDINE GLUCONATE 2% SOLUTION	GOJO Industries, Inc.	743021cd-38c3-3825-e053-2a91aa0aa7f2	2018-08-24	Warnings	Exact identifier application applno (NDA): 019422 application number: NDA019422
Antiseptic Foam Handwash	CHLORHEXIDINE GLUCONATE 2% SOLUTION	GOJO Industries, Inc.	74317b4d-3fbf-6fd5-e053-2a91aa0ab90f	2018-08-24	Warnings	Exact identifier application applno (NDA): 019422 application number: NDA019422

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
1245230	chlorhexidine gluconate 2 % Medicated Liquid Soap	PSN	2dc7bdc7-5d78-57ee-e054-00144ff8d46c	9
1245230	chlorhexidine gluconate 20 MG/ML Medicated Liquid Soap	SCD	2dc7bdc7-5d78-57ee-e054-00144ff8d46c	9
1245230	chlorhexidine gluconate 2 % Medicated Liquid Soap	SY	2dc7bdc7-5d78-57ee-e054-00144ff8d46c	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63517-113-04	63517011304	118 mL in 1 BOTTLE, PLASTIC (63517-113-04)	118 ml	2015-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
2% Cardinal Health	Cardinal Health \| Xttrium Laboratories, Inc. \| Xttirum Laboratories, Inc.	2019-07-23	HUMAN OTC DRUG LABEL	9