Sirenol Antiseptic Topical

Product NDC: 80441-002
11-digit product format: 804410002
Labeler code: 80441
Product ID: 80441-002_b0a5f86d-ccad-4f88-ab36-ed3013aa5859
Type: HUMAN OTC DRUG
Nonproprietary name: ALCOHOL
Dosage form: GEL
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 · 17 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	80441-002		I	Inactivated by FDA	2026-10-16
excluded package	package	80441-002	80441-002-01	I	Inactivated by FDA	2026-10-16
excluded package	package	80441-002	80441-002-02	I	Inactivated by FDA	2026-10-16
excluded package	package	80441-002	80441-002-03	I	Inactivated by FDA	2026-10-16
excluded package	package	80441-002	80441-002-04	I	Inactivated by FDA	2026-10-16
excluded package	package	80441-002	80441-002-05	I	Inactivated by FDA	2026-10-16
excluded package	package	80441-002	80441-002-06	I	Inactivated by FDA	2026-10-16
excluded package	package	80441-002	80441-002-07	I	Inactivated by FDA	2026-10-16
excluded package	package	80441-002	80441-002-08	I	Inactivated by FDA	2026-10-16
excluded package	package	80441-002	80441-002-09	I	Inactivated by FDA	2026-10-16
excluded package	package	80441-002	80441-002-10	I	Inactivated by FDA	2026-10-16
excluded package	package	80441-002	80441-002-11	I	Inactivated by FDA	2026-10-16
excluded package	package	80441-002	80441-002-12	I	Inactivated by FDA	2026-10-16
excluded package	package	80441-002	80441-002-13	I	Inactivated by FDA	2026-10-16
excluded package	package	80441-002	80441-002-14	I	Inactivated by FDA	2026-10-16
excluded package	package	80441-002	80441-002-15	I	Inactivated by FDA	2026-10-16
excluded package	package	80441-002	80441-002-16	I	Inactivated by FDA	2026-10-16

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 · 306 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	80441-002-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80441-002-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80441-002-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80441-002-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80441-002-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80441-002-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80441-002-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80441-002-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80441-002-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80441-002-13	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80441-002-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80441-002-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80441-002-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80441-002-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80441-002-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80441-002-07	`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	80441-002-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80441-002-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80441-002-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80441-002-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80441-002-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80441-002-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80441-002-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80441-002-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80441-002-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80441-002-13	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80441-002-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80441-002-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80441-002-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80441-002-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80441-002-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80441-002-07	`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	80441-002-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80441-002-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80441-002-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80441-002-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80441-002-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80441-002-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80441-002-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80441-002-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80441-002-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80441-002-13	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80441-002-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80441-002-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80441-002-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80441-002-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80441-002-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80441-002-07	`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	80441-002-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80441-002-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80441-002-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80441-002-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80441-002-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80441-002-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80441-002-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80441-002-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
80441-002-01	Sirenol Antiseptic Topical Gel
80441-002-02	Sirenol Antiseptic Topical Gel
80441-002-03	Sirenol Antiseptic Topical Gel
80441-002-04	Sirenol Antiseptic Topical Gel
80441-002-05	Sirenol Antiseptic Topical Gel
80441-002-06	Sirenol Antiseptic Topical Gel
80441-002-07	Sirenol Antiseptic Topical Gel
80441-002-08	Sirenol Antiseptic Topical Gel
80441-002-09	Sirenol Antiseptic Topical Gel
80441-002-10	Sirenol Antiseptic Topical Gel
80441-002-11	Sirenol Antiseptic Topical Gel
80441-002-12	Sirenol Antiseptic Topical Gel
80441-002-13	Sirenol Antiseptic Topical Gel
80441-002-14	Sirenol Antiseptic Topical Gel
80441-002-15	Sirenol Antiseptic Topical Gel
80441-002-16	Sirenol Antiseptic Topical Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
80441-002-01	Sirenol Antiseptic Topical	25 mL in 1 BOTTLE	GEL	25	1
80441-002-02	Sirenol Antiseptic Topical	50 mL in 1 BOTTLE	GEL	50	1
80441-002-03	Sirenol Antiseptic Topical	100 mL in 1 BOTTLE	GEL	100	1
80441-002-04	Sirenol Antiseptic Topical	150 mL in 1 BOTTLE	GEL	150	1
80441-002-05	Sirenol Antiseptic Topical	200 mL in 1 BOTTLE	GEL	200	1
80441-002-06	Sirenol Antiseptic Topical	250 mL in 1 BOTTLE	GEL	250	1
80441-002-07	Sirenol Antiseptic Topical	500 mL in 1 BOTTLE	GEL	500	1
80441-002-08	Sirenol Antiseptic Topical	1000 mL in 1 BOTTLE	GEL	1000	1
80441-002-09	Sirenol Antiseptic Topical	3785 mL in 1 BOTTLE	GEL	3785	1
80441-002-10	Sirenol Antiseptic Topical	5000 mL in 1 BOTTLE	GEL	5000	1
80441-002-11	Sirenol Antiseptic Topical	10000 mL in 1 BOTTLE	GEL	10000	1
80441-002-12	Sirenol Antiseptic Topical	6 in 1 PACKAGE	GEL	6	1
80441-002-12	Sirenol Antiseptic Topical	5 mL in 1 NOT APPLICABLE	GEL	5	1
80441-002-13	Sirenol Antiseptic Topical	5 mL in 1 NOT APPLICABLE	GEL	5	1
80441-002-13	Sirenol Antiseptic Topical	10 in 1 PACKAGE	GEL	10	1
80441-002-14	Sirenol Antiseptic Topical	20 in 1 PACKAGE	GEL	20	1
80441-002-14	Sirenol Antiseptic Topical	5 mL in 1 NOT APPLICABLE	GEL	5	1
80441-002-15	Sirenol Antiseptic Topical	5 mL in 1 NOT APPLICABLE	GEL	5	1
80441-002-15	Sirenol Antiseptic Topical	100 in 1 PACKAGE	GEL	100	1
80441-002-16	Sirenol Antiseptic Topical	5 mL in 1 NOT APPLICABLE	GEL	5	1
80441-002-16	Sirenol Antiseptic Topical	1000 in 1 PACKAGE	GEL	1000	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80441-002	SIRENOL ANTISEPTIC TOPICAL (ALCOHOL) GEL [BM GLOBAL ELEKTRONIK GIDA SANAYI VE DIS TICARET LIMITED SIRKETI]	1	Legacy NDC, 21 package rows	20200910_f26bfa16-3c9e-45ef-8156-988095b869f6.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
1041498	ethanol 80 % Topical Gel	PSN	f26bfa16-3c9e-45ef-8156-988095b869f6	1
1041498	ethanol 0.8 ML/ML Topical Gel	SCD	f26bfa16-3c9e-45ef-8156-988095b869f6	1
1041498	ethanol 80 % Topical Gel	SY	f26bfa16-3c9e-45ef-8156-988095b869f6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80441-002-01	80441000201	25 mL in 1 BOTTLE (80441-002-01)	25 ml	2020-09-02	0000-00-00	No	No	Current
80441-002-02	80441000202	50 mL in 1 BOTTLE (80441-002-02)	50 ml	2020-09-02	0000-00-00	No	No	Current
80441-002-03	80441000203	100 mL in 1 BOTTLE (80441-002-03)	100 ml	2020-09-02	0000-00-00	No	No	Current
80441-002-04	80441000204	150 mL in 1 BOTTLE (80441-002-04)	150 ml	2020-09-02	0000-00-00	No	No	Current
80441-002-05	80441000205	200 mL in 1 BOTTLE (80441-002-05)	200 ml	2020-09-02	0000-00-00	No	No	Current
80441-002-06	80441000206	250 mL in 1 BOTTLE (80441-002-06)	250 ml	2020-09-02	0000-00-00	No	No	Current
80441-002-07	80441000207	500 mL in 1 BOTTLE (80441-002-07)	500 ml	2020-09-02	0000-00-00	No	No	Current
80441-002-08	80441000208	1000 mL in 1 BOTTLE (80441-002-08)	1000 ml	2020-09-02	0000-00-00	No	No	Current
80441-002-09	80441000209	3785 mL in 1 BOTTLE (80441-002-09)	3785 ml	2020-09-02	0000-00-00	No	No	Current
80441-002-10	80441000210	5000 mL in 1 BOTTLE (80441-002-10)	5000 ml	2020-09-02	0000-00-00	No	No	Current
80441-002-11	80441000211	10000 mL in 1 BOTTLE (80441-002-11)	10000 ml	2020-09-02	0000-00-00	No	No	Current
80441-002-12	80441000212	6 NOT APPLICABLE in 1 PACKAGE (80441-002-12) > 5 mL in 1 NOT APPLICABLE	6 not applicable	2020-09-02	0000-00-00	No	No	Current
80441-002-13	80441000213	10 NOT APPLICABLE in 1 PACKAGE (80441-002-13) > 5 mL in 1 NOT APPLICABLE	10 not applicable	2020-09-02	0000-00-00	No	No	Current
80441-002-14	80441000214	20 NOT APPLICABLE in 1 PACKAGE (80441-002-14) > 5 mL in 1 NOT APPLICABLE	20 not applicable	2020-09-02	0000-00-00	No	No	Current
80441-002-15	80441000215	100 NOT APPLICABLE in 1 PACKAGE (80441-002-15) > 5 mL in 1 NOT APPLICABLE	100 not applicable	2020-09-02	0000-00-00	No	No	Current
80441-002-16	80441000216	1000 NOT APPLICABLE in 1 PACKAGE (80441-002-16) > 5 mL in 1 NOT APPLICABLE	1000 not applicable	2020-09-02	0000-00-00	No	No	Current

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