PREMIER PURE Protection

Product NDC: 73945-004
11-digit product format: 739450004
Labeler code: 73945
Product ID: 73945-004_8f25edb6-72e1-4884-9687-f1fc00f02667
Type: HUMAN OTC DRUG
Nonproprietary name: Ethyl Alcohol
Dosage form: GEL
Route: TOPICAL
Labeler: RPP PRODUCTS, INC.
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-04-10
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 72 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 · 13 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	73945-004		I	Inactivated by FDA	2026-10-05
excluded package	package	73945-004	73945-004-01	I	Inactivated by FDA	2026-10-05
excluded package	package	73945-004	73945-004-02	I	Inactivated by FDA	2026-10-05
excluded package	package	73945-004	73945-004-03	I	Inactivated by FDA	2026-10-05
excluded package	package	73945-004	73945-004-04	I	Inactivated by FDA	2026-10-05
excluded package	package	73945-004	73945-004-05	I	Inactivated by FDA	2026-10-05
excluded package	package	73945-004	73945-004-06	I	Inactivated by FDA	2026-10-05
excluded package	package	73945-004	73945-004-07	I	Inactivated by FDA	2026-10-05
excluded package	package	73945-004	73945-004-08	I	Inactivated by FDA	2026-10-05
excluded package	package	73945-004	73945-004-09	I	Inactivated by FDA	2026-10-05
excluded package	package	73945-004	73945-004-10	I	Inactivated by FDA	2026-10-05
excluded package	package	73945-004	73945-004-11	I	Inactivated by FDA	2026-10-05
excluded package	package	73945-004	73945-004-12	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 4 · 234 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	73945-004-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	73945-004-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	73945-004-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	73945-004-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	73945-004-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	73945-004-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	73945-004-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	73945-004-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	73945-004-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	73945-004-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	73945-004-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	73945-004-02	`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	73945-004-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	73945-004-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	73945-004-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	73945-004-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	73945-004-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	73945-004-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	73945-004-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	73945-004-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	73945-004-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	73945-004-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	73945-004-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	73945-004-02	`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	73945-004-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	73945-004-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	73945-004-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	73945-004-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	73945-004-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	73945-004-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	73945-004-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	73945-004-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	73945-004-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	73945-004-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	73945-004-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	73945-004-02	`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	73945-004-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	73945-004-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	73945-004-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	73945-004-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	73945-004-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	73945-004-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	73945-004-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	73945-004-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	73945-004-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	73945-004-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	73945-004-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	73945-004-02	`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	73945-004-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	73945-004-11	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	73945-004-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	73945-004-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	73945-004-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	73945-004-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	73945-004-05	`cfe11265f3b6…`	`090c488252e2…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
424daadb-95de-8ece-97f5-235e3f7f0001	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
73945-004-01	3c11775e-0032-45ef-982c-1d3b78b00f46
73945-004-02	3c11775e-0032-45ef-982c-1d3b78b00f46
73945-004-03	3c11775e-0032-45ef-982c-1d3b78b00f46
73945-004-04	3c11775e-0032-45ef-982c-1d3b78b00f46
73945-004-05	3c11775e-0032-45ef-982c-1d3b78b00f46
73945-004-06	3c11775e-0032-45ef-982c-1d3b78b00f46
73945-004-07	3c11775e-0032-45ef-982c-1d3b78b00f46
73945-004-08	3c11775e-0032-45ef-982c-1d3b78b00f46
73945-004-09	3c11775e-0032-45ef-982c-1d3b78b00f46
73945-004-10	3c11775e-0032-45ef-982c-1d3b78b00f46
73945-004-11	3c11775e-0032-45ef-982c-1d3b78b00f46
73945-004-12	3c11775e-0032-45ef-982c-1d3b78b00f46

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
73945-004-01	PREMIER PURE Protection	59 mL in 1 BOTTLE, PLASTIC	GEL	59	1
73945-004-02	PREMIER PURE Protection	88.72 mL in 1 BOTTLE, PLASTIC	GEL	88.72	1
73945-004-03	PREMIER PURE Protection	118.3 mL in 1 BOTTLE, PLASTIC	GEL	118.3	1
73945-004-04	PREMIER PURE Protection	236.59 mL in 1 BOTTLE, PLASTIC	GEL	236.59	1
73945-004-05	PREMIER PURE Protection	295.74 mL in 1 BOTTLE, PLASTIC	GEL	295.74	1
73945-004-06	PREMIER PURE Protection	354.88 mL in 1 BOTTLE, PLASTIC	GEL	354.88	1
73945-004-07	PREMIER PURE Protection	443.17 mL in 1 BOTTLE, PLASTIC	GEL	443.17	1
73945-004-08	PREMIER PURE Protection	946 mL in 1 BOTTLE, PLASTIC	GEL	946	1
73945-004-09	PREMIER PURE Protection	1890 mL in 1 BOTTLE, PLASTIC	GEL	1890	1
73945-004-10	PREMIER PURE Protection	2000 mL in 1 BOTTLE, PLASTIC	GEL	2000	1
73945-004-11	PREMIER PURE Protection	2800 mL in 1 BOTTLE, PLASTIC	GEL	2800	1
73945-004-12	PREMIER PURE Protection	3780 mL in 1 BOTTLE, PLASTIC	GEL	3780	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73945-004	PREMIER PURE PROTECTION (ETHYL ALCOHOL) GEL [RPP PRODUCTS, INC.]	1	Legacy NDC, 12 package rows	20200507_3c11775e-0032-45ef-982c-1d3b78b00f46.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
2277550	ethanol 72 % Topical Gel	PSN	3c11775e-0032-45ef-982c-1d3b78b00f46	1
2277550	ethanol 0.72 ML/ML Topical Gel	SCD	3c11775e-0032-45ef-982c-1d3b78b00f46	1
2277550	ethanol 72 % Topical Gel	SY	3c11775e-0032-45ef-982c-1d3b78b00f46	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
73945-004-01	73945000401	59 mL in 1 BOTTLE, PLASTIC (73945-004-01)	59 ml	2020-04-10	0000-00-00	No	No	Current
73945-004-02	73945000402	88.72 mL in 1 BOTTLE, PLASTIC (73945-004-02)	88.72 ml	2020-04-10	0000-00-00	No	No	Current
73945-004-03	73945000403	118.3 mL in 1 BOTTLE, PLASTIC (73945-004-03)	118.3 ml	2020-04-10	0000-00-00	No	No	Current
73945-004-04	73945000404	236.59 mL in 1 BOTTLE, PLASTIC (73945-004-04)	236.59 ml	2020-04-10	0000-00-00	No	No	Current
73945-004-05	73945000405	295.74 mL in 1 BOTTLE, PLASTIC (73945-004-05)	295.74 ml	2020-04-10	0000-00-00	No	No	Current
73945-004-06	73945000406	354.88 mL in 1 BOTTLE, PLASTIC (73945-004-06)	354.88 ml	2020-04-10	0000-00-00	No	No	Current
73945-004-07	73945000407	443.17 mL in 1 BOTTLE, PLASTIC (73945-004-07)	443.17 ml	2020-04-10	0000-00-00	No	No	Current
73945-004-08	73945000408	946 mL in 1 BOTTLE, PLASTIC (73945-004-08)	946 ml	2020-04-10	0000-00-00	No	No	Current
73945-004-09	73945000409	1890 mL in 1 BOTTLE, PLASTIC (73945-004-09)	1890 ml	2020-04-10	0000-00-00	No	No	Current
73945-004-10	73945000410	2000 mL in 1 BOTTLE, PLASTIC (73945-004-10)	2000 ml	2020-04-10	0000-00-00	No	No	Current
73945-004-11	73945000411	2800 mL in 1 BOTTLE, PLASTIC (73945-004-11)	2800 ml	2020-04-10	0000-00-00	No	No	Current
73945-004-12	73945000412	3780 mL in 1 BOTTLE, PLASTIC (73945-004-12)	3780 ml	2020-04-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PREMIER PURE Protection - RPP PRODUCTS, INC.	RPP PRODUCTS, INC.	2020-05-05	HUMAN OTC DRUG LABEL	1