Xtreme Kleen

Product NDC: 67761-503
11-digit product format: 677610503
Labeler code: 67761
Product ID: 67761-503_a4721fae-4040-f8bb-e053-2995a90a6c54
Type: HUMAN OTC DRUG
Nonproprietary name: ALCOHOL
Dosage form: LIQUID
Route: TOPICAL
Labeler: Transchemical Incorporated
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-03-30
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 80 mL/100mL
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 9 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	67761-503		I	Inactivated by FDA	2026-10-12
excluded package	package	67761-503	67761-503-02	I	Inactivated by FDA	2026-10-12
excluded package	package	67761-503	67761-503-03	I	Inactivated by FDA	2026-10-12
excluded package	package	67761-503	67761-503-04	I	Inactivated by FDA	2026-10-12
excluded package	package	67761-503	67761-503-05	I	Inactivated by FDA	2026-10-12
excluded package	package	67761-503	67761-503-06	I	Inactivated by FDA	2026-10-12
excluded package	package	67761-503	67761-503-07	I	Inactivated by FDA	2026-10-12
excluded package	package	67761-503	67761-503-08	I	Inactivated by FDA	2026-10-12
excluded package	package	67761-503	67761-503-09	I	Inactivated by FDA	2026-10-12

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 3 · 162 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	67761-503-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67761-503-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67761-503-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67761-503-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67761-503-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67761-503-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67761-503-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67761-503-03	`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	67761-503-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67761-503-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67761-503-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67761-503-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67761-503-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67761-503-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67761-503-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67761-503-03	`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	67761-503-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67761-503-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67761-503-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67761-503-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67761-503-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67761-503-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67761-503-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67761-503-03	`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	67761-503-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67761-503-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67761-503-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67761-503-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67761-503-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67761-503-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67761-503-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67761-503-03	`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	67761-503-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67761-503-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67761-503-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67761-503-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67761-503-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67761-503-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67761-503-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67761-503-03	`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	67761-503-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67761-503-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67761-503-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67761-503-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67761-503-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67761-503-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67761-503-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67761-503-03	`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	67761-503-07	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67761-503-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67761-503-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67761-503-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67761-503-08	`302b2466d912…`	`e7b80fea0513…`

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
5eb9f24b-9328-475e-af0a-18021935eb6a	Product name	1	20180220

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
67761-503-02	a47221c4-173b-7e49-e053-2a95a90ad159
67761-503-03	a47221c4-173b-7e49-e053-2a95a90ad159
67761-503-04	a47221c4-173b-7e49-e053-2a95a90ad159
67761-503-05	a47221c4-173b-7e49-e053-2a95a90ad159
67761-503-06	a47221c4-173b-7e49-e053-2a95a90ad159
67761-503-07	a47221c4-173b-7e49-e053-2a95a90ad159
67761-503-08	a47221c4-173b-7e49-e053-2a95a90ad159
67761-503-09	a47221c4-173b-7e49-e053-2a95a90ad159

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67761-503-02	Xtreme Kleen	651 mL in 1 BOTTLE	LIQUID	651	2
67761-503-03	Xtreme Kleen	1893 mL in 1 BOTTLE	LIQUID	1893	2
67761-503-04	Xtreme Kleen	3785 mL in 1 JUG	LIQUID	3785	2
67761-503-05	Xtreme Kleen	18927 mL in 1 PAIL	LIQUID	18927	2
67761-503-06	Xtreme Kleen	946 mL in 1 BOTTLE	LIQUID	946	2
67761-503-07	Xtreme Kleen	118 mL in 1 BOTTLE	LIQUID	118	2
67761-503-08	Xtreme Kleen	237 mL in 1 BOTTLE	LIQUID	237	2
67761-503-09	Xtreme Kleen	59 mL in 1 BOTTLE	LIQUID	59	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67761-503	XTREME KLEEN (ALCOHOL) LIQUID [TRANSCHEMICAL INCORPORATED]	2	Legacy NDC, 8 package rows	20200430_a47221c4-173b-7e49-e053-2a95a90ad159.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3K9958V90M	ALCOHOL	64-17-5	ALCOHOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1039339	ethanol 80 % Topical Solution	PSN	a47221c4-173b-7e49-e053-2a95a90ad159	2
1039339	ethanol 0.8 ML/ML Topical Solution	SCD	a47221c4-173b-7e49-e053-2a95a90ad159	2
1039339	ethanol 80 % Topical Solution	SY	a47221c4-173b-7e49-e053-2a95a90ad159	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67761-503-02	67761050302	651 mL in 1 BOTTLE (67761-503-02)	651 ml	2020-03-30	0000-00-00	No	No	Current
67761-503-03	67761050303	1893 mL in 1 BOTTLE (67761-503-03)	1893 ml	2020-03-30	0000-00-00	No	No	Current
67761-503-04	67761050304	3785 mL in 1 JUG (67761-503-04)	3785 ml	2020-03-30	0000-00-00	No	No	Current
67761-503-05	67761050305	18927 mL in 1 PAIL (67761-503-05)	18927 ml	2020-03-30	0000-00-00	No	No	Current
67761-503-06	67761050306	946 mL in 1 BOTTLE (67761-503-06)	946 ml	2020-03-30	0000-00-00	No	No	Current
67761-503-07	67761050307	118 mL in 1 BOTTLE (67761-503-07)	118 ml	2020-03-30	0000-00-00	No	No	Current
67761-503-08	67761050308	237 mL in 1 BOTTLE (67761-503-08)	237 ml	2020-03-30	0000-00-00	No	No	Current
67761-503-09	67761050309	59 mL in 1 BOTTLE (67761-503-09)	59 ml	2020-03-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Xtreme Kleen - Transchemical Incorporated	Transchemical Incorporated	2020-04-29	HUMAN OTC DRUG LABEL	2