CHLORA-CLEANZE

Product NDC: 71389-001
Requested package NDC: 71389-001-03
11-digit product format: 713890001
Labeler code: 71389
Product ID: 71389-001_54484bc3-ec17-4ae0-e054-00144ff88e88
Type: HUMAN OTC DRUG
Nonproprietary name: chlorhexidine gluconate and isopropyl alcohol
Dosage form: SWAB
Route: TOPICAL
Labeler: Biotronix Healthcare Industries, Inc.
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2017-04-18
Marketing end: 0000-00-00
Substance: CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
Active strength: 20 mg/mL; mL/mL
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	71389-001	71389-001-03	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 1 · 18 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…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`

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, Indexing SPL, Related label table
NDC	Indexing SPL	Related label
71389-001-01	d6a99b39-8281-a426-e053-dadaa90af4c2	4de49446-71ba-372a-e054-00144ff8d46c
71389-001-02	d6a99b39-d000-a426-e053-dadaa90af4c2	4de58778-9aad-54f0-e054-00144ff8d46c
71389-001-03	d6a99b39-688c-a426-e053-dadaa90af4c2	4de58778-9ac1-54f0-e054-00144ff8d46c
71389-001-04	d6a99b39-9c6d-a426-e053-dadaa90af4c2	4de58778-9ae1-54f0-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71389-001-01	CHLORA-CLEANZE	0.67 mL in 1 POUCH	SWAB	0.67	2
71389-001-02	CHLORA-CLEANZE	1.5 mL in 1 POUCH	SWAB	1.5	2
71389-001-03	CHLORA-CLEANZE	1.75 mL in 1 POUCH	SWAB	1.75	2
71389-001-04	CHLORA-CLEANZE	3 mL in 1 POUCH	SWAB	3	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71389-001	CHLORA-CLEANZE (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SWAB [BIOTRONIX HEALTHCARE INDUSTRIES, INC.]	2	Legacy NDC, 1 package rows	20170705_4de49446-71ba-372a-e054-00144ff8d46c.zip
71389-001	CHLORA-CLEANZE (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SWAB [BIOTRONIX HEALTHCARE INDUSTRIES, INC.]	2	Legacy NDC, 1 package rows	20170714_4de58778-9ac1-54f0-e054-00144ff8d46c.zip
71389-001	CHLORA-CLEANZE (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SWAB [BIOTRONIX HEALTHCARE INDUSTRIES, INC.]	2	Legacy NDC, 1 package rows	20170714_4de58778-9ae1-54f0-e054-00144ff8d46c.zip
71389-001	CHLORA-CLEANZE (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SWAB [BIOTRONIX HEALTHCARE INDUSTRIES, INC.]	2	Legacy NDC, 1 package rows	20170714_4de58778-9aad-54f0-e054-00144ff8d46c.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
MOR84MUD8E	CHLORHEXIDINE GLUCONATE	18472-51-0	CHLORHEXIDINE GLUCONATE
ND2M416302	ISOPROPYL ALCOHOL	67-63-0	ISOPROPYL ALCOHOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1918214	chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Medicated Pad	PSN	4de49446-71ba-372a-e054-00144ff8d46c	2
1918214	chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Medicated Pad	PSN	4de58778-9aad-54f0-e054-00144ff8d46c	2
1918214	chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Medicated Pad	PSN	4de58778-9ac1-54f0-e054-00144ff8d46c	2
1918214	chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Medicated Pad	PSN	4de58778-9ae1-54f0-e054-00144ff8d46c	2
1918214	chlorhexidine gluconate 20 MG/ML / isopropyl alcohol 0.7 ML/ML Medicated Pad	SCD	4de49446-71ba-372a-e054-00144ff8d46c	2
1918214	chlorhexidine gluconate 20 MG/ML / isopropyl alcohol 0.7 ML/ML Medicated Pad	SCD	4de58778-9aad-54f0-e054-00144ff8d46c	2
1918214	chlorhexidine gluconate 20 MG/ML / isopropyl alcohol 0.7 ML/ML Medicated Pad	SCD	4de58778-9ac1-54f0-e054-00144ff8d46c	2
1918214	chlorhexidine gluconate 20 MG/ML / isopropyl alcohol 0.7 ML/ML Medicated Pad	SCD	4de58778-9ae1-54f0-e054-00144ff8d46c	2
1918214	chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Medicated Pad	SY	4de49446-71ba-372a-e054-00144ff8d46c	2
1918214	chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Medicated Pad	SY	4de58778-9aad-54f0-e054-00144ff8d46c	2
1918214	chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Medicated Pad	SY	4de58778-9ac1-54f0-e054-00144ff8d46c	2
1918214	chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Medicated Pad	SY	4de58778-9ae1-54f0-e054-00144ff8d46c	2
1918214	chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Topical Swab	SY	4de49446-71ba-372a-e054-00144ff8d46c	2
1918214	chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Topical Swab	SY	4de58778-9aad-54f0-e054-00144ff8d46c	2
1918214	chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Topical Swab	SY	4de58778-9ac1-54f0-e054-00144ff8d46c	2
1918214	chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Topical Swab	SY	4de58778-9ae1-54f0-e054-00144ff8d46c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71389-001-03	71389000103	1.75 mL in 1 POUCH (71389-001-03)	1.75 ml	2017-04-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CHLORA-CLEANZE	Biotronix Healthcare Industries, Inc. \| US MED PHARM SUPPLIES, INC. \| Longood Medicine (Beijing) Co., Ltd.	2017-07-14	HUMAN OTC DRUG LABEL	2
CHLORA-CLEANZE	Biotronix Healthcare Industries, Inc. \| US MED PHARM SUPPLIES, INC. \| Longood Medicine (Beijing) Co., Ltd.	2017-07-14	HUMAN OTC DRUG LABEL	2
CHLORA-CLEANZE	Biotronix Healthcare Industries, Inc. \| US MED PHARM SUPPLIES, INC. \| Longood Medicine (Beijing) Co., Ltd.	2017-07-14	HUMAN OTC DRUG LABEL	2
CHLORA-CLEANZE	Biotronix Healthcare Industries, Inc. \| US MED PHARM SUPPLIES, INC. \| Longood Medicine (Beijing) Co., Ltd.	2017-07-05	HUMAN OTC DRUG LABEL	2