DermaGel

Product NDC: 58575-130
11-digit product format: 585750130
Labeler code: 58575
Product ID: 58575-130_c17290b6-2cce-9f78-e053-2995a90a5548
Type: HUMAN OTC DRUG
Nonproprietary name: ALCOHOL
Dosage form: GEL
Route: TOPICAL
Labeler: Inopak. Ltd
Application: part333E
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 1990-09-01
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 70 mL/100mL
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 11 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	58575-130		I	Inactivated by FDA	2026-10-05
excluded package	package	58575-130	58575-130-02	I	Inactivated by FDA	2026-10-05
excluded package	package	58575-130	58575-130-04	I	Inactivated by FDA	2026-10-05
excluded package	package	58575-130	58575-130-08	I	Inactivated by FDA	2026-10-05
excluded package	package	58575-130	58575-130-10	D	Discontinued by firm	2026-10-05
excluded package	package	58575-130	58575-130-18	I	Inactivated by FDA	2026-10-05
excluded package	package	58575-130	58575-130-37	I	Inactivated by FDA	2026-10-05
excluded package	package	58575-130	58575-130-65	I	Inactivated by FDA	2026-10-05
excluded package	package	58575-130	58575-130-80	D	Discontinued by firm	2026-10-05
excluded package	package	58575-130	58575-130-81	I	Inactivated by FDA	2026-10-05
excluded package	package	58575-130	58575-130-82	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 · 159 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58575-130-37	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58575-130-82	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58575-130-81	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58575-130-02	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58575-130-08	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58575-130-18	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58575-130-80	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58575-130-65	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58575-130-04	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58575-130-10	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58575-130-37	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58575-130-82	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58575-130-81	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58575-130-02	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58575-130-08	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58575-130-18	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58575-130-80	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58575-130-65	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58575-130-04	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58575-130-10	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58575-130-37	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58575-130-82	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58575-130-81	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58575-130-02	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58575-130-08	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58575-130-18	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58575-130-80	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58575-130-65	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58575-130-04	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58575-130-10	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58575-130-37	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58575-130-82	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58575-130-81	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58575-130-02	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58575-130-08	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58575-130-18	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58575-130-80	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58575-130-65	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58575-130-04	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58575-130-10	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58575-130-37	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58575-130-82	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58575-130-81	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58575-130-02	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58575-130-08	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58575-130-18	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58575-130-80	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58575-130-65	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58575-130-04	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58575-130-10	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58575-130-37	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58575-130-82	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58575-130-81	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58575-130-02	I	Inactivated by FDA	`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
58575-130-02	DermaGel Hand Sanitizing Gel
58575-130-04	DermaGel Hand Sanitizing Gel
58575-130-08	DermaGel Hand Sanitizing Gel
58575-130-10	DermaGel Hand Sanitizing Gel
58575-130-18	DermaGel Hand Sanitizing Gel
58575-130-37	DermaGel Hand Sanitizing Gel
58575-130-65	DermaGel Hand Sanitizing Gel
58575-130-80	DermaGel Hand Sanitizing Gel
58575-130-81	DermaGel Hand Sanitizing Gel
58575-130-82	DermaGel Hand Sanitizing Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58575-130-02	DermaGelHAND SANITIZING	60 mL in 1 BOTTLE, DISPENSING	GEL	60	7
58575-130-04	DermaGelHAND SANITIZING	118 mL in 1 BOTTLE, DISPENSING	GEL	118	7
58575-130-08	DermaGelHAND SANITIZING	237 mL in 1 BOTTLE, PUMP	GEL	237	7
58575-130-10	DermaGelHAND SANITIZING	1000 mL in 1 BAG	GEL	1000	7
58575-130-18	DermaGelHAND SANITIZING	532 mL in 1 BOTTLE, PUMP	GEL	532	7
58575-130-37	DermaGelHAND SANITIZING	3785 mL in 1 JUG	GEL	3785	7
58575-130-65	DermaGelHAND SANITIZING	650 mL in 1 BAG	GEL	650	7
58575-130-80	DermaGelHAND SANITIZING	800 mL in 1 BAG	GEL	800	7
58575-130-81	DermaGelHAND SANITIZING	800 mL in 1 POUCH	GEL	800	7
58575-130-82	DermaGelHAND SANITIZING	1000 mL in 1 POUCH	GEL	1000	7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALCOHOL	ACTIVE INGREDIENT	3K9958V90M	DERMAGEL HAND SANITIZING (ALCOHOL) GEL [INOPAK. LTD]	1
ALCOHOL	ACTIVE MOIETY	3K9958V90M	DERMAGEL HAND SANITIZING (ALCOHOL) GEL [INOPAK. LTD]	1
AMINOMETHYLPROPANOL	INACTIVE INGREDIENT	LU49E6626Q	DERMAGEL HAND SANITIZING (ALCOHOL) GEL [INOPAK. LTD]	1
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	132584PQMO	DERMAGEL HAND SANITIZING (ALCOHOL) GEL [INOPAK. LTD]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DERMAGEL HAND SANITIZING (ALCOHOL) GEL [INOPAK. LTD]	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	DERMAGEL HAND SANITIZING (ALCOHOL) GEL [INOPAK. LTD]	1
METHYLCHLOROISOTHIAZOLINONE	INACTIVE INGREDIENT	DEL7T5QRPN	DERMAGEL HAND SANITIZING (ALCOHOL) GEL [INOPAK. LTD]	1
METHYLISOTHIAZOLINONE	INACTIVE INGREDIENT	229D0E1QFA	DERMAGEL HAND SANITIZING (ALCOHOL) GEL [INOPAK. LTD]	1
PEG/PPG-18/18 DIMETHICONE	INACTIVE INGREDIENT	9H0AO7T794	DERMAGEL HAND SANITIZING (ALCOHOL) GEL [INOPAK. LTD]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	DERMAGEL HAND SANITIZING (ALCOHOL) GEL [INOPAK. LTD]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58575-130	DERMAGEL HAND SANITIZING (ALCOHOL) GEL [INOPAK. LTD]	7	Legacy NDC, 10 package rows	20210504_bc0a55b6-c506-4dc7-a8f7-dcb447f6a2d2.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	bc0a55b6-c506-4dc7-a8f7-dcb447f6a2d2	7
581662	ethanol 0.7 ML/ML Topical Gel	SCD	bc0a55b6-c506-4dc7-a8f7-dcb447f6a2d2	7
581662	ethanol 70 % Topical Gel	SY	bc0a55b6-c506-4dc7-a8f7-dcb447f6a2d2	7
581662	ethyl alcohol 70 % Topical Gel	SY	bc0a55b6-c506-4dc7-a8f7-dcb447f6a2d2	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58575-130-02	58575013002	60 mL in 1 BOTTLE, DISPENSING (58575-130-02)	60 ml	1990-09-01	0000-00-00	No	No	Current
58575-130-04	58575013004	118 mL in 1 BOTTLE, DISPENSING (58575-130-04)	118 ml	1990-09-01	0000-00-00	No	No	Current
58575-130-08	58575013008	237 mL in 1 BOTTLE, PUMP (58575-130-08)	237 ml	1990-09-01	0000-00-00	No	No	Current
58575-130-10	58575013010	1000 mL in 1 BAG	1000 ml					Historical
58575-130-18	58575013018	532 mL in 1 BOTTLE, PUMP (58575-130-18)	532 ml	1990-09-01	0000-00-00	No	No	Current
58575-130-37	58575013037	3785 mL in 1 JUG (58575-130-37)	3785 ml	1990-09-01	0000-00-00	No	No	Current
58575-130-65	58575013065	650 mL in 1 BAG (58575-130-65)	650 ml	1990-09-01	0000-00-00	No	No	Current
58575-130-80	58575013080	800 mL in 1 BAG	800 ml					Historical
58575-130-81	58575013081	800 mL in 1 POUCH (58575-130-81)	800 ml	1990-09-01	0000-00-00	No	No	Current
58575-130-82	58575013082	1000 mL in 1 POUCH (58575-130-82)	1000 ml	1990-09-01	0000-00-00	No	No	Current