Sirenol Antiseptic Topical

Product NDC: 80441-001
11-digit product format: 804410001
Labeler code: 80441
Product ID: 80441-001_b10bfd21-0eea-4784-81e0-505a9a8ae270
Type: HUMAN OTC DRUG
Nonproprietary name: ALCOHOL
Dosage form: SOLUTION
Route: TOPICAL
Labeler: BM GLOBAL ELEKTRONIK GIDA SANAYI VE DIS TICARET LIMITED SIRKETI
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-09-02
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 · 20 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	80441-001		I	Inactivated by FDA	2026-08-07
excluded package	package	80441-001	80441-001-01	I	Inactivated by FDA	2026-08-07
excluded package	package	80441-001	80441-001-02	I	Inactivated by FDA	2026-08-07
excluded package	package	80441-001	80441-001-03	I	Inactivated by FDA	2026-08-07
excluded package	package	80441-001	80441-001-04	I	Inactivated by FDA	2026-08-07
excluded package	package	80441-001	80441-001-05	I	Inactivated by FDA	2026-08-07
excluded package	package	80441-001	80441-001-06	I	Inactivated by FDA	2026-08-07
excluded package	package	80441-001	80441-001-07	I	Inactivated by FDA	2026-08-07
excluded package	package	80441-001	80441-001-08	I	Inactivated by FDA	2026-08-07
excluded package	package	80441-001	80441-001-09	I	Inactivated by FDA	2026-08-07
excluded package	package	80441-001	80441-001-10	I	Inactivated by FDA	2026-08-07
excluded package	package	80441-001	80441-001-11	I	Inactivated by FDA	2026-08-07
excluded package	package	80441-001	80441-001-12	I	Inactivated by FDA	2026-08-07
excluded package	package	80441-001	80441-001-13	I	Inactivated by FDA	2026-08-07
excluded package	package	80441-001	80441-001-14	I	Inactivated by FDA	2026-08-07
excluded package	package	80441-001	80441-001-15	I	Inactivated by FDA	2026-08-07
excluded package	package	80441-001	80441-001-16	I	Inactivated by FDA	2026-08-07
excluded package	package	80441-001	80441-001-17	I	Inactivated by FDA	2026-08-07
excluded package	package	80441-001	80441-001-18	I	Inactivated by FDA	2026-08-07
excluded package	package	80441-001	80441-001-19	I	Inactivated by FDA	2026-08-07

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 6 · 360 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	80441-001-18	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80441-001-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80441-001-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80441-001-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80441-001-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80441-001-13	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80441-001-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80441-001-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80441-001-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80441-001-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80441-001-17	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80441-001-19	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80441-001-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80441-001-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80441-001-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80441-001-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80441-001-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80441-001-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80441-001-08	`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	80441-001-18	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80441-001-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80441-001-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80441-001-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80441-001-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80441-001-13	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80441-001-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80441-001-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80441-001-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80441-001-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80441-001-17	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80441-001-19	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80441-001-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80441-001-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80441-001-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80441-001-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80441-001-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80441-001-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80441-001-08	`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	80441-001-18	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80441-001-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80441-001-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80441-001-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80441-001-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80441-001-13	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80441-001-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80441-001-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80441-001-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80441-001-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80441-001-17	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80441-001-19	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80441-001-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80441-001-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80441-001-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80441-001-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80441-001-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80441-001-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80441-001-08	`2ef7874e63bc…`	`57b86245f4fa…`

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
80441-001-01	Sirenol Antiseptic Topical Solution
80441-001-02	Sirenol Antiseptic Topical Solution
80441-001-03	Sirenol Antiseptic Topical Solution
80441-001-04	Sirenol Antiseptic Topical Solution
80441-001-05	Sirenol Antiseptic Topical Solution
80441-001-06	Sirenol Antiseptic Topical Solution
80441-001-07	Sirenol Antiseptic Topical Solution
80441-001-08	Sirenol Antiseptic Topical Solution
80441-001-09	Sirenol Antiseptic Topical Solution
80441-001-10	Sirenol Antiseptic Topical Solution
80441-001-11	Sirenol Antiseptic Topical Solution
80441-001-12	Sirenol Antiseptic Topical Solution
80441-001-13	Sirenol Antiseptic Topical Solution
80441-001-14	Sirenol Antiseptic Topical Solution
80441-001-15	Sirenol Antiseptic Topical Solution
80441-001-16	Sirenol Antiseptic Topical Solution
80441-001-17	Sirenol Antiseptic Topical Solution
80441-001-18	Sirenol Antiseptic Topical Solution
80441-001-19	Sirenol Antiseptic Topical Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
80441-001-01	Sirenol Antiseptic Topical	6 in 1 PACKAGE	SOLUTION	6	1
80441-001-01	Sirenol Antiseptic Topical	5 mL in 1 NOT APPLICABLE	SOLUTION	5	1
80441-001-02	Sirenol Antiseptic Topical	10 in 1 PACKAGE	SOLUTION	10	1
80441-001-02	Sirenol Antiseptic Topical	5 mL in 1 NOT APPLICABLE	SOLUTION	5	1
80441-001-03	Sirenol Antiseptic Topical	20 in 1 PACKAGE	SOLUTION	20	1
80441-001-03	Sirenol Antiseptic Topical	5 mL in 1 NOT APPLICABLE	SOLUTION	5	1
80441-001-04	Sirenol Antiseptic Topical	100 in 1 PACKAGE	SOLUTION	100	1
80441-001-04	Sirenol Antiseptic Topical	5 mL in 1 NOT APPLICABLE	SOLUTION	5	1
80441-001-05	Sirenol Antiseptic Topical	5 mL in 1 NOT APPLICABLE	SOLUTION	5	1
80441-001-05	Sirenol Antiseptic Topical	1000 in 1 PACKAGE	SOLUTION	1000	1
80441-001-06	Sirenol Antiseptic Topical	60 in 1 BOTTLE	SOLUTION	60	1
80441-001-06	Sirenol Antiseptic Topical	150 mL in 1 NOT APPLICABLE	SOLUTION	150	1
80441-001-07	Sirenol Antiseptic Topical	80 in 1 BOTTLE	SOLUTION	80	1
80441-001-07	Sirenol Antiseptic Topical	200 mL in 1 NOT APPLICABLE	SOLUTION	200	1
80441-001-08	Sirenol Antiseptic Topical	250 mL in 1 NOT APPLICABLE	SOLUTION	250	1
80441-001-08	Sirenol Antiseptic Topical	100 in 1 BOTTLE	SOLUTION	100	1
80441-001-09	Sirenol Antiseptic Topical	25 mL in 1 BOTTLE	SOLUTION	25	1
80441-001-10	Sirenol Antiseptic Topical	50 mL in 1 BOTTLE	SOLUTION	50	1
80441-001-11	Sirenol Antiseptic Topical	100 mL in 1 BOTTLE	SOLUTION	100	1
80441-001-12	Sirenol Antiseptic Topical	150 mL in 1 BOTTLE	SOLUTION	150	1
80441-001-13	Sirenol Antiseptic Topical	200 mL in 1 BOTTLE	SOLUTION	200	1
80441-001-14	Sirenol Antiseptic Topical	250 mL in 1 BOTTLE	SOLUTION	250	1
80441-001-15	Sirenol Antiseptic Topical	500 mL in 1 BOTTLE	SOLUTION	500	1
80441-001-16	Sirenol Antiseptic Topical	1000 mL in 1 BOTTLE	SOLUTION	1000	1
80441-001-17	Sirenol Antiseptic Topical	3785 mL in 1 BOTTLE	SOLUTION	3785	1
80441-001-18	Sirenol Antiseptic Topical	5000 mL in 1 BOTTLE	SOLUTION	5000	1
80441-001-19	Sirenol Antiseptic Topical	10000 mL in 1 BOTTLE	SOLUTION	10000	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80441-001	SIRENOL ANTISEPTIC TOPICAL (ALCOHOL) SOLUTION [BM GLOBAL ELEKTRONIK GIDA SANAYI VE DIS TICARET LIMITED SIRKETI]	1	Legacy NDC, 27 package rows	20200910_f26854eb-eec7-477c-9dbf-c13eb089bfa3.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	f26854eb-eec7-477c-9dbf-c13eb089bfa3	1
1039339	ethanol 0.8 ML/ML Topical Solution	SCD	f26854eb-eec7-477c-9dbf-c13eb089bfa3	1
1039339	ethanol 80 % Topical Solution	SY	f26854eb-eec7-477c-9dbf-c13eb089bfa3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80441-001-01	80441000101	6 NOT APPLICABLE in 1 PACKAGE (80441-001-01) > 5 mL in 1 NOT APPLICABLE	6 not applicable	2020-09-02	0000-00-00	No	No	Current
80441-001-02	80441000102	10 NOT APPLICABLE in 1 PACKAGE (80441-001-02) > 5 mL in 1 NOT APPLICABLE	10 not applicable	2020-09-02	0000-00-00	No	No	Current
80441-001-03	80441000103	20 NOT APPLICABLE in 1 PACKAGE (80441-001-03) > 5 mL in 1 NOT APPLICABLE	20 not applicable	2020-09-02	0000-00-00	No	No	Current
80441-001-04	80441000104	100 NOT APPLICABLE in 1 PACKAGE (80441-001-04) > 5 mL in 1 NOT APPLICABLE	100 not applicable	2020-09-02	0000-00-00	No	No	Current
80441-001-05	80441000105	1000 NOT APPLICABLE in 1 PACKAGE (80441-001-05) > 5 mL in 1 NOT APPLICABLE	1000 not applicable	2020-09-02	0000-00-00	No	No	Current
80441-001-06	80441000106	60 NOT APPLICABLE in 1 BOTTLE (80441-001-06) > 150 mL in 1 NOT APPLICABLE	60 not applicable	2020-09-02	0000-00-00	No	No	Current
80441-001-07	80441000107	80 NOT APPLICABLE in 1 BOTTLE (80441-001-07) > 200 mL in 1 NOT APPLICABLE	80 not applicable	2020-09-02	0000-00-00	No	No	Current
80441-001-08	80441000108	100 NOT APPLICABLE in 1 BOTTLE (80441-001-08) > 250 mL in 1 NOT APPLICABLE	100 not applicable	2020-09-02	0000-00-00	No	No	Current
80441-001-09	80441000109	25 mL in 1 BOTTLE (80441-001-09)	25 ml	2020-09-02	0000-00-00	No	No	Current
80441-001-10	80441000110	50 mL in 1 BOTTLE (80441-001-10)	50 ml	2020-09-02	0000-00-00	No	No	Current
80441-001-11	80441000111	100 mL in 1 BOTTLE (80441-001-11)	100 ml	2020-09-02	0000-00-00	No	No	Current
80441-001-12	80441000112	150 mL in 1 BOTTLE (80441-001-12)	150 ml	2020-09-02	0000-00-00	No	No	Current
80441-001-13	80441000113	200 mL in 1 BOTTLE (80441-001-13)	200 ml	2020-09-02	0000-00-00	No	No	Current
80441-001-14	80441000114	250 mL in 1 BOTTLE (80441-001-14)	250 ml	2020-09-02	0000-00-00	No	No	Current
80441-001-15	80441000115	500 mL in 1 BOTTLE (80441-001-15)	500 ml	2020-09-02	0000-00-00	No	No	Current
80441-001-16	80441000116	1000 mL in 1 BOTTLE (80441-001-16)	1000 ml	2020-09-02	0000-00-00	No	No	Current
80441-001-17	80441000117	3785 mL in 1 BOTTLE (80441-001-17)	3785 ml	2020-09-02	0000-00-00	No	No	Current
80441-001-18	80441000118	5000 mL in 1 BOTTLE (80441-001-18)	5000 ml	2020-09-02	0000-00-00	No	No	Current
80441-001-19	80441000119	10000 mL in 1 BOTTLE (80441-001-19)	10000 ml	2020-09-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sirenol Antiseptic Topical Solution	BM GLOBAL ELEKTRONIK GIDA SANAYI VE DIS TICARET LIMITED SIRKETI	2020-09-02	HUMAN OTC DRUG LABEL	1