B-Protek

Product NDC: 80308-002
11-digit product format: 803080002
Labeler code: 80308
Product ID: 80308-002_dfecdd36-2e4f-46b9-9e1c-fad36ffedd48
Type: HUMAN OTC DRUG
Nonproprietary name: ISOPROPYL ALCOHOL
Dosage form: GEL
Route: TOPICAL
Labeler: Grupo Siller Ingenier
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-09-24
Marketing end: 0000-00-00
Substance: ISOPROPYL 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 · 8 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	80308-002		I	Inactivated by FDA	2026-10-05
excluded package	package	80308-002	80308-002-01	I	Inactivated by FDA	2026-10-05
excluded package	package	80308-002	80308-002-02	I	Inactivated by FDA	2026-10-05
excluded package	package	80308-002	80308-002-03	I	Inactivated by FDA	2026-10-05
excluded package	package	80308-002	80308-002-04	I	Inactivated by FDA	2026-10-05
excluded package	package	80308-002	80308-002-05	I	Inactivated by FDA	2026-10-05
excluded package	package	80308-002	80308-002-06	I	Inactivated by FDA	2026-10-05
excluded package	package	80308-002	80308-002-07	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 3 · 144 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	80308-002-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80308-002-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80308-002-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80308-002-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80308-002-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80308-002-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80308-002-03	`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	80308-002-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80308-002-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80308-002-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80308-002-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80308-002-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80308-002-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80308-002-03	`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	80308-002-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80308-002-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80308-002-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80308-002-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80308-002-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80308-002-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80308-002-03	`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	80308-002-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80308-002-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80308-002-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80308-002-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80308-002-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80308-002-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80308-002-03	`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	80308-002-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80308-002-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80308-002-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80308-002-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80308-002-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80308-002-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80308-002-03	`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	80308-002-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80308-002-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80308-002-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80308-002-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80308-002-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80308-002-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80308-002-03	`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	80308-002-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	80308-002-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	80308-002-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	80308-002-07	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	80308-002-06	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	80308-002-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	80308-002-03	`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	80308-002-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	80308-002-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	80308-002-01	`ed331223b511…`	`672a5bd82f5f…`

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
80308-002-01	684bbfc0-fc95-400e-a77d-3e827db3ce57
80308-002-02	684bbfc0-fc95-400e-a77d-3e827db3ce57
80308-002-03	684bbfc0-fc95-400e-a77d-3e827db3ce57
80308-002-04	684bbfc0-fc95-400e-a77d-3e827db3ce57
80308-002-05	684bbfc0-fc95-400e-a77d-3e827db3ce57
80308-002-06	684bbfc0-fc95-400e-a77d-3e827db3ce57
80308-002-07	684bbfc0-fc95-400e-a77d-3e827db3ce57

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
80308-002-01	B-Protek	3 mL in 1 POUCH	GEL	3	1
80308-002-02	B-Protek	30 mL in 1 BOTTLE, PLASTIC	GEL	30	1
80308-002-03	B-Protek	60 mL in 1 BOTTLE, PLASTIC	GEL	60	1
80308-002-04	B-Protek	250 mL in 1 BOTTLE, PLASTIC	GEL	250	1
80308-002-05	B-Protek	500 mL in 1 BOTTLE, PLASTIC	GEL	500	1
80308-002-06	B-Protek	1000 mL in 1 BOTTLE, PLASTIC	GEL	1000	1
80308-002-07	B-Protek	3785 mL in 1 BOTTLE, PLASTIC	GEL	3785	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80308-002	B-PROTEK (ISOPROPYL ALCOHOL) GEL [GRUPO SILLER INGENIER&IACUTE;A CONSTRUCCI&OACUTE;N Y MATERIALES, S.A. DE C.V]	1	Legacy NDC, 7 package rows	20200926_684bbfc0-fc95-400e-a77d-3e827db3ce57.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
ND2M416302	ISOPROPYL ALCOHOL	67-63-0	ISOPROPYL ALCOHOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2397699	isopropyl alcohol 80 % Topical Gel	PSN	684bbfc0-fc95-400e-a77d-3e827db3ce57	1
2397699	isopropyl alcohol 0.8 ML/ML Topical Gel	SCD	684bbfc0-fc95-400e-a77d-3e827db3ce57	1
2397699	isopropyl alcohol 80 % Topical Gel	SY	684bbfc0-fc95-400e-a77d-3e827db3ce57	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80308-002-01	80308000201	3 mL in 1 POUCH (80308-002-01)	3 ml	2020-09-24	0000-00-00	No	No	Current
80308-002-02	80308000202	30 mL in 1 BOTTLE, PLASTIC (80308-002-02)	30 ml	2020-09-24	0000-00-00	No	No	Current
80308-002-03	80308000203	60 mL in 1 BOTTLE, PLASTIC (80308-002-03)	60 ml	2020-09-24	0000-00-00	No	No	Current
80308-002-04	80308000204	250 mL in 1 BOTTLE, PLASTIC (80308-002-04)	250 ml	2020-09-24	0000-00-00	No	No	Current
80308-002-05	80308000205	500 mL in 1 BOTTLE, PLASTIC (80308-002-05)	500 ml	2020-09-24	0000-00-00	No	No	Current
80308-002-06	80308000206	1000 mL in 1 BOTTLE, PLASTIC (80308-002-06)	1000 ml	2020-09-24	0000-00-00	No	No	Current
80308-002-07	80308000207	3785 mL in 1 BOTTLE, PLASTIC (80308-002-07)	3785 ml	2020-09-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
B-Protek	Grupo Siller Ingeniería Construcción y Materiales, S.A. de C.V	2020-09-24	HUMAN OTC DRUG LABEL	1