PRIME

Product NDC: 79382-001
11-digit product format: 793820001
Labeler code: 79382
Product ID: 79382-001_a5ca392e-9e7f-4259-b2eb-90e6197dee89
Type: HUMAN OTC DRUG
Nonproprietary name: Alcohol
Dosage form: GEL
Route: TOPICAL
Labeler: Prime Industries Usa, Inc
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-06-26
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 75 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	79382-001		I	Inactivated by FDA	2026-10-05
excluded package	package	79382-001	79382-001-01	I	Inactivated by FDA	2026-10-05
excluded package	package	79382-001	79382-001-02	I	Inactivated by FDA	2026-10-05
excluded package	package	79382-001	79382-001-03	I	Inactivated by FDA	2026-10-05
excluded package	package	79382-001	79382-001-04	I	Inactivated by FDA	2026-10-05
excluded package	package	79382-001	79382-001-05	I	Inactivated by FDA	2026-10-05
excluded package	package	79382-001	79382-001-06	I	Inactivated by FDA	2026-10-05
excluded package	package	79382-001	79382-001-07	I	Inactivated by FDA	2026-10-05
excluded package	package	79382-001	79382-001-08	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 · 171 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	79382-001-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	79382-001-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	79382-001-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	79382-001-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	79382-001-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	79382-001-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	79382-001-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	79382-001-02	`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	79382-001-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	79382-001-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	79382-001-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	79382-001-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	79382-001-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	79382-001-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	79382-001-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	79382-001-02	`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	79382-001-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	79382-001-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	79382-001-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	79382-001-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	79382-001-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	79382-001-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	79382-001-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	79382-001-02	`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	79382-001-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	79382-001-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	79382-001-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	79382-001-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	79382-001-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	79382-001-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	79382-001-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	79382-001-02	`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	79382-001-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	79382-001-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	79382-001-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	79382-001-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	79382-001-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	79382-001-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	79382-001-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	79382-001-02	`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	79382-001-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	79382-001-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	79382-001-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	79382-001-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	79382-001-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	79382-001-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	79382-001-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	79382-001-02	`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	79382-001-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	79382-001-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	79382-001-06	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	79382-001-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	79382-001-08	`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
79382-001-01	f2f03954-f47c-43f7-be63-376959b2059e
79382-001-02	f2f03954-f47c-43f7-be63-376959b2059e
79382-001-03	f2f03954-f47c-43f7-be63-376959b2059e
79382-001-04	f2f03954-f47c-43f7-be63-376959b2059e
79382-001-05	f2f03954-f47c-43f7-be63-376959b2059e
79382-001-06	f2f03954-f47c-43f7-be63-376959b2059e
79382-001-07	f2f03954-f47c-43f7-be63-376959b2059e
79382-001-08	f2f03954-f47c-43f7-be63-376959b2059e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
79382-001-01	PRIME	30 mL in 1 BOTTLE, PLASTIC	GEL	30	2
79382-001-02	PRIME	60 mL in 1 BOTTLE, PLASTIC	GEL	60	2
79382-001-03	PRIME	100 mL in 1 BOTTLE, PLASTIC	GEL	100	2
79382-001-04	PRIME	237 mL in 1 BOTTLE, PLASTIC	GEL	237	2
79382-001-05	PRIME	500 mL in 1 BOTTLE, PLASTIC	GEL	500	2
79382-001-06	PRIME	1000 mL in 1 DRUM	GEL	1000	2
79382-001-07	PRIME	5000 mL in 1 DRUM	GEL	5000	2
79382-001-08	PRIME	200000 mL in 1 DRUM	GEL	200000	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
79382-001	PRIME (ALCOHOL) GEL [PRIME INDUSTRIES USA, INC]	2	Legacy NDC, 8 package rows	20200807_f2f03954-f47c-43f7-be63-376959b2059e.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
1305100	ethanol 75 % Topical Gel	PSN	f2f03954-f47c-43f7-be63-376959b2059e	2
1305100	ethanol 0.75 ML/ML Topical Gel	SCD	f2f03954-f47c-43f7-be63-376959b2059e	2
1305100	ethanol 75 % Topical Gel	SY	f2f03954-f47c-43f7-be63-376959b2059e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
79382-001-01	79382000101	30 mL in 1 BOTTLE, PLASTIC (79382-001-01)	30 ml	2020-06-26	0000-00-00	No	No	Current
79382-001-02	79382000102	60 mL in 1 BOTTLE, PLASTIC (79382-001-02)	60 ml	2020-06-26	0000-00-00	No	No	Current
79382-001-03	79382000103	100 mL in 1 BOTTLE, PLASTIC (79382-001-03)	100 ml	2020-06-26	0000-00-00	No	No	Current
79382-001-04	79382000104	237 mL in 1 BOTTLE, PLASTIC (79382-001-04)	237 ml	2020-06-26	0000-00-00	No	No	Current
79382-001-05	79382000105	500 mL in 1 BOTTLE, PLASTIC (79382-001-05)	500 ml	2020-06-26	0000-00-00	No	No	Current
79382-001-06	79382000106	1000 mL in 1 DRUM (79382-001-06)	1000 ml	2020-06-26	0000-00-00	No	No	Current
79382-001-07	79382000107	5000 mL in 1 DRUM (79382-001-07)	5000 ml	2020-06-26	0000-00-00	No	No	Current
79382-001-08	79382000108	200000 mL in 1 DRUM (79382-001-08)	200000 ml	2020-06-26	0000-00-00	No	No	Current