Purmist

Product NDC: 50353-100
11-digit product format: 503530100
Labeler code: 50353
Product ID: 50353-100_44f1506a-45ff-44e9-a016-014f5ecb740b
Type: HUMAN OTC DRUG
Nonproprietary name: CHLORHEXIDINE GLUCONATE, ETHYL ALCOHOL
Dosage form: SOLUTION
Route: TOPICAL
Labeler: MKR International Inc
Application: part333
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2010-06-01
Marketing end: 0000-00-00
Substance: ALCOHOL; CHLORHEXIDINE GLUCONATE
Active strength: 1 g/mL; g/mL
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50353-100		I	Inactivated by FDA	2026-10-05
excluded package	package	50353-100	50353-100-10	I	Inactivated by FDA	2026-10-05
excluded package	package	50353-100	50353-100-20	I	Inactivated by FDA	2026-10-05
excluded package	package	50353-100	50353-100-50	I	Inactivated by FDA	2026-10-05

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 2 · 88 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	50353-100-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50353-100-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50353-100-10	`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	50353-100-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50353-100-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50353-100-10	`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	50353-100-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50353-100-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50353-100-10	`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	50353-100-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50353-100-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50353-100-10	`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	50353-100-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50353-100-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50353-100-10	`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	50353-100-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50353-100-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50353-100-10	`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	50353-100-20	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50353-100-50	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50353-100-10	`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	50353-100-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50353-100-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50353-100-10	`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	50353-100-20	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50353-100-50	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50353-100-10	`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	50353-100-20	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50353-100-50	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50353-100-10	`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	50353-100-20	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50353-100-50	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50353-100-10	`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	50353-100-20	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50353-100-50	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50353-100-10	`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	50353-100-20	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50353-100-50	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50353-100-10	`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	50353-100-20	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50353-100-50	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50353-100-10	`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	50353-100-20	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50353-100-50	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50353-100-10	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
50353-100-10	2019-10-21	C162847	48780-1	956f9ecf-cde6-621f-e053-dbdaa90a74ad	Hand Sanitizer
50353-100-20	2019-10-21	C162847	48780-1	956f9ecf-cde6-621f-e053-dbdaa90a74ad	Hand Sanitizer
50353-100-50	2019-10-21	C162847	48780-1	956f9ecf-cde6-621f-e053-dbdaa90a74ad	Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50353-100-10	Purmist	7.1 mL in 1 BOTTLE, PUMP	SOLUTION	7.1	4
50353-100-10	Purmist	1 in 1 BLISTER PACK	SOLUTION	1	4
50353-100-20	Purmist	400 mL in 1 BAG	SOLUTION	400	4
50353-100-20	Purmist	6 in 1 CARTON	SOLUTION	6	4
50353-100-50	Purmist	100 mL in 1 BOTTLE, SPRAY	SOLUTION	100	4
50353-100-50	Purmist	6 in 1 CARTON	SOLUTION	6	4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALCOHOL	ACTIVE INGREDIENT	3K9958V90M	PURMIST (CHLORHEXIDINE GLUCONATE, ETHYL ALCOHOL) SOLUTION [MKR INTERNATIONAL INC]	4
CHLORHEXIDINE GLUCONATE	ACTIVE INGREDIENT	MOR84MUD8E	PURMIST (CHLORHEXIDINE GLUCONATE, ETHYL ALCOHOL) SOLUTION [MKR INTERNATIONAL INC]	4
ALCOHOL	ACTIVE MOIETY	3K9958V90M	PURMIST (CHLORHEXIDINE GLUCONATE, ETHYL ALCOHOL) SOLUTION [MKR INTERNATIONAL INC]	4
CHLORHEXIDINE	ACTIVE MOIETY	R4KO0DY52L	PURMIST (CHLORHEXIDINE GLUCONATE, ETHYL ALCOHOL) SOLUTION [MKR INTERNATIONAL INC]	4
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	PURMIST (CHLORHEXIDINE GLUCONATE, ETHYL ALCOHOL) SOLUTION [MKR INTERNATIONAL INC]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	PURMIST (CHLORHEXIDINE GLUCONATE, ETHYL ALCOHOL) SOLUTION [MKR INTERNATIONAL INC]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50353-100	PURMIST (CHLORHEXIDINE GLUCONATE, ETHYL ALCOHOL) SOLUTION [MKR INTERNATIONAL INC]	4	Legacy NDC, 6 package rows	20100629_9524a7fb-eabb-4da3-a12a-c0085878bb95.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3K9958V90M	ALCOHOL	64-17-5	ALCOHOL
MOR84MUD8E	CHLORHEXIDINE GLUCONATE	18472-51-0	CHLORHEXIDINE GLUCONATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049648	ethanol 70 % / chlorhexidine gluconate 1 % Topical Solution	PSN	9524a7fb-eabb-4da3-a12a-c0085878bb95	4
1049648	chlorhexidine gluconate 10 MG/ML / ethanol 0.7 ML/ML Topical Solution	SCD	9524a7fb-eabb-4da3-a12a-c0085878bb95	4
1049648	chlorhexidine gluconate 1 % / ethanol 70 % Topical Solution	SY	9524a7fb-eabb-4da3-a12a-c0085878bb95	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
50353-100-10	50353010010	7.1 mL in 1 BOTTLE, PUMP	7.1 ml	Historical
50353-100-20	50353010020	400 mL in 1 BAG	400 ml	Historical
50353-100-50	50353010050	100 mL in 1 BOTTLE, SPRAY	100 ml	Historical