Hand Gel Prolim Instant Hand Sanitizer

Product NDC: 50414-100
11-digit product format: 504140100
Labeler code: 50414
Product ID: 50414-100_ac63737f-53f9-4668-8921-78f25a44f20b
Type: HUMAN OTC DRUG
Nonproprietary name: Alcohol
Dosage form: GEL
Route: TOPICAL
Labeler: Prolim Quimica Avancada Ltda.
Application: part333
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2010-03-10
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 1 mg/mL
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 10 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50414-100		I	Inactivated by FDA	2026-10-12
excluded package	package	50414-100	50414-100-01	I	Inactivated by FDA	2026-10-12
excluded package	package	50414-100	50414-100-02	I	Inactivated by FDA	2026-10-12
excluded package	package	50414-100	50414-100-03	I	Inactivated by FDA	2026-10-12
excluded package	package	50414-100	50414-100-04	I	Inactivated by FDA	2026-10-12
excluded package	package	50414-100	50414-100-05	I	Inactivated by FDA	2026-10-12
excluded package	package	50414-100	50414-100-06	I	Inactivated by FDA	2026-10-12
excluded package	package	50414-100	50414-100-07	I	Inactivated by FDA	2026-10-12
excluded package	package	50414-100	50414-100-08	I	Inactivated by FDA	2026-10-12
excluded package	package	50414-100	50414-100-09	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 4 · 220 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	50414-100-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50414-100-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50414-100-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50414-100-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50414-100-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50414-100-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50414-100-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50414-100-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50414-100-02	`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	50414-100-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50414-100-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50414-100-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50414-100-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50414-100-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50414-100-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50414-100-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50414-100-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50414-100-02	`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	50414-100-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50414-100-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50414-100-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50414-100-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50414-100-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50414-100-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50414-100-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50414-100-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50414-100-02	`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	50414-100-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50414-100-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50414-100-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50414-100-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50414-100-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50414-100-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50414-100-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50414-100-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50414-100-02	`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	50414-100-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50414-100-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50414-100-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50414-100-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50414-100-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50414-100-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50414-100-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50414-100-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50414-100-02	`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	50414-100-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50414-100-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50414-100-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50414-100-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50414-100-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50414-100-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50414-100-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50414-100-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50414-100-02	`cdf11ea48f46…`	`ba0047e9e063…`

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
50414-100-01	Drug Facts
50414-100-02	Drug Facts
50414-100-03	Drug Facts
50414-100-04	Drug Facts
50414-100-05	Drug Facts
50414-100-06	Drug Facts
50414-100-07	Drug Facts
50414-100-08	Drug Facts
50414-100-09	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50414-100-01	Hand Gel Prolim Instant Hand Sanitizer	60 mL in 1 BOTTLE, PLASTIC	GEL	60	1
50414-100-02	Hand Gel Prolim Instant Hand Sanitizer	80 mL in 1 BOTTLE, PLASTIC	GEL	80	1
50414-100-03	Hand Gel Prolim Instant Hand Sanitizer	100 mL in 1 BOTTLE, PLASTIC	GEL	100	1
50414-100-04	Hand Gel Prolim Instant Hand Sanitizer	200 mL in 1 BOTTLE, PUMP	GEL	200	1
50414-100-05	Hand Gel Prolim Instant Hand Sanitizer	500 mL in 1 BOTTLE, PUMP	GEL	500	1
50414-100-06	Hand Gel Prolim Instant Hand Sanitizer	1000 mL in 1 BOTTLE, PUMP	GEL	1000	1
50414-100-07	Hand Gel Prolim Instant Hand Sanitizer	5000 mL in 1 BOTTLE, PLASTIC	GEL	5000	1
50414-100-08	Hand Gel Prolim Instant Hand Sanitizer	1 in 1 BOX	GEL	1	1
50414-100-08	Hand Gel Prolim Instant Hand Sanitizer	800 mL in 1 BAG	GEL	800	1
50414-100-09	Hand Gel Prolim Instant Hand Sanitizer	1 in 1 BOX	GEL	1	1
50414-100-09	Hand Gel Prolim Instant Hand Sanitizer	1200 mL in 1 BAG	GEL	1200	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
Alcohol	ACTIVE INGREDIENT	3K9958V90M	HAND GEL PROLIM INSTANT HAND SANITIZER (ALCOHOL) GEL [PROLIM QUIMICA AVANCADA LTDA.]	1
Alcohol	ACTIVE MOIETY	3K9958V90M	HAND GEL PROLIM INSTANT HAND SANITIZER (ALCOHOL) GEL [PROLIM QUIMICA AVANCADA LTDA.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50414-100	HAND GEL PROLIM INSTANT HAND SANITIZER (ALCOHOL) GEL [PROLIM QUIMICA AVANCADA LTDA.]	1	Legacy NDC, 11 package rows	20100310_2c0441c7-96e9-4b2b-b851-527badd7429a.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
581662	ethanol 70 % Topical Gel	PSN	2c0441c7-96e9-4b2b-b851-527badd7429a	1
581662	ethanol 0.7 ML/ML Topical Gel	SCD	2c0441c7-96e9-4b2b-b851-527badd7429a	1
581662	ethanol 70 % Topical Gel	SY	2c0441c7-96e9-4b2b-b851-527badd7429a	1
581662	ethyl alcohol 70 % Topical Gel	SY	2c0441c7-96e9-4b2b-b851-527badd7429a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
50414-100-01	50414010001	60 mL in 1 BOTTLE, PLASTIC	60 ml	Historical
50414-100-02	50414010002	80 mL in 1 BOTTLE, PLASTIC	80 ml	Historical
50414-100-03	50414010003	100 mL in 1 BOTTLE, PLASTIC	100 ml	Historical
50414-100-04	50414010004	200 mL in 1 BOTTLE, PUMP	200 ml	Historical
50414-100-05	50414010005	500 mL in 1 BOTTLE, PUMP	500 ml	Historical
50414-100-06	50414010006	1000 mL in 1 BOTTLE, PUMP	1000 ml	Historical
50414-100-07	50414010007	5000 mL in 1 BOTTLE, PLASTIC	5000 ml	Historical
50414-100-08	50414010008	1 in 1 BOX		Historical
50414-100-09	50414010009	1 in 1 BOX		Historical