Devolver Premium Gel

Product NDC: 75001-201
11-digit product format: 750010201
Labeler code: 75001
Product ID: 75001-201_a718fcbb-20ed-4230-e053-2995a90a0961
Type: HUMAN OTC DRUG
Nonproprietary name: Alcohol
Dosage form: GEL
Route: TOPICAL
Labeler: Devolver Cosmetics Co., Ltd
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-05-08
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 70 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 · 9 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	75001-201		I	Inactivated by FDA	2026-10-12
excluded package	package	75001-201	75001-201-01	I	Inactivated by FDA	2026-10-12
excluded package	package	75001-201	75001-201-02	I	Inactivated by FDA	2026-10-12
excluded package	package	75001-201	75001-201-03	I	Inactivated by FDA	2026-10-12
excluded package	package	75001-201	75001-201-04	I	Inactivated by FDA	2026-10-12
excluded package	package	75001-201	75001-201-05	I	Inactivated by FDA	2026-10-12
excluded package	package	75001-201	75001-201-06	I	Inactivated by FDA	2026-10-12
excluded package	package	75001-201	75001-201-07	I	Inactivated by FDA	2026-10-12
excluded package	package	75001-201	75001-201-08	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 3 · 162 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	75001-201-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75001-201-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75001-201-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75001-201-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75001-201-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75001-201-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75001-201-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75001-201-03	`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	75001-201-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75001-201-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75001-201-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75001-201-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75001-201-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75001-201-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75001-201-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75001-201-03	`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	75001-201-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75001-201-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75001-201-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75001-201-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75001-201-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75001-201-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75001-201-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75001-201-03	`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	75001-201-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75001-201-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75001-201-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75001-201-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75001-201-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75001-201-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75001-201-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75001-201-03	`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	75001-201-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	75001-201-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	75001-201-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	75001-201-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	75001-201-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	75001-201-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	75001-201-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	75001-201-03	`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	75001-201-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	75001-201-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	75001-201-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	75001-201-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	75001-201-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	75001-201-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	75001-201-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	75001-201-03	`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	75001-201-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	75001-201-07	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	75001-201-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	75001-201-08	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	75001-201-02	`302b2466d912…`	`e7b80fea0513…`

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
75001-201-01	a4a675f8-5edb-6aa0-e053-2995a90a6280
75001-201-02	a4a675f8-5edb-6aa0-e053-2995a90a6280
75001-201-03	a4a675f8-5edb-6aa0-e053-2995a90a6280
75001-201-04	a4a675f8-5edb-6aa0-e053-2995a90a6280
75001-201-05	a4a675f8-5edb-6aa0-e053-2995a90a6280
75001-201-06	a4a675f8-5edb-6aa0-e053-2995a90a6280
75001-201-07	a4a675f8-5edb-6aa0-e053-2995a90a6280
75001-201-08	a4a675f8-5edb-6aa0-e053-2995a90a6280

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
75001-201-01	Devolver Premium Gel	60 mL in 1 BOTTLE	GEL	60	2
75001-201-02	Devolver Premium Gel	100 mL in 1 BOTTLE	GEL	100	2
75001-201-03	Devolver Premium Gel	236 mL in 1 BOTTLE, PUMP	GEL	236	2
75001-201-04	Devolver Premium Gel	500 mL in 1 BOTTLE, PUMP	GEL	500	2
75001-201-05	Devolver Premium Gel	3785 mL in 1 BOTTLE	GEL	3785	2
75001-201-06	Devolver Premium Gel	120 mL in 1 BOTTLE	GEL	120	2
75001-201-07	Devolver Premium Gel	350 mL in 1 BOTTLE	GEL	350	2
75001-201-08	Devolver Premium Gel	300 mL in 1 BOTTLE	GEL	300	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75001-201	DEVOLVER PREMIUM GEL (ALCOHOL) GEL [DEVOLVER COSMETICS CO., LTD]	2	Legacy NDC, 8 package rows	20200603_a4a675f8-5edb-6aa0-e053-2995a90a6280.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	a4a675f8-5edb-6aa0-e053-2995a90a6280	2
581662	ethanol 0.7 ML/ML Topical Gel	SCD	a4a675f8-5edb-6aa0-e053-2995a90a6280	2
581662	ethanol 70 % Topical Gel	SY	a4a675f8-5edb-6aa0-e053-2995a90a6280	2
581662	ethyl alcohol 70 % Topical Gel	SY	a4a675f8-5edb-6aa0-e053-2995a90a6280	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
75001-201-01	75001020101	60 mL in 1 BOTTLE (75001-201-01)	60 ml	2020-05-08	0000-00-00	No	No	Current
75001-201-02	75001020102	100 mL in 1 BOTTLE (75001-201-02)	100 ml	2020-05-08	0000-00-00	No	No	Current
75001-201-03	75001020103	236 mL in 1 BOTTLE, PUMP (75001-201-03)	236 ml	2020-05-08	0000-00-00	No	No	Current
75001-201-04	75001020104	500 mL in 1 BOTTLE, PUMP (75001-201-04)	500 ml	2020-05-08	0000-00-00	No	No	Current
75001-201-05	75001020105	3785 mL in 1 BOTTLE (75001-201-05)	3785 ml	2020-05-08	0000-00-00	No	No	Current
75001-201-06	75001020106	120 mL in 1 BOTTLE (75001-201-06)	120 ml	2020-06-02	0000-00-00	No	No	Current
75001-201-07	75001020107	350 mL in 1 BOTTLE (75001-201-07)	350 ml	2020-06-02	0000-00-00	No	No	Current
75001-201-08	75001020108	300 mL in 1 BOTTLE (75001-201-08)	300 ml	2020-06-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Devolver Premium Gel - Devolver Cosmetics Co., Ltd	Devolver Cosmetics Co., Ltd	2020-06-02	HUMAN OTC DRUG LABEL	2