PUROMA

Product NDC: 80948-002
11-digit product format: 809480002
Labeler code: 80948
Product ID: 80948-002_d94bffbc-0b47-0f29-e053-2a95a90ade01
Type: HUMAN OTC DRUG
Nonproprietary name: ALCOHOL
Dosage form: GEL
Route: TOPICAL
Labeler: ZENITH MICRO CONTROL
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-12-20
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 70 mL/100mL
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 18 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	80948-002		I	Inactivated by FDA	2026-10-05
excluded package	package	80948-002	80948-002-01	I	Inactivated by FDA	2026-10-05
excluded package	package	80948-002	80948-002-02	I	Inactivated by FDA	2026-10-05
excluded package	package	80948-002	80948-002-03	I	Inactivated by FDA	2026-10-05
excluded package	package	80948-002	80948-002-04	I	Inactivated by FDA	2026-10-05
excluded package	package	80948-002	80948-002-05	I	Inactivated by FDA	2026-10-05
excluded package	package	80948-002	80948-002-06	I	Inactivated by FDA	2026-10-05
excluded package	package	80948-002	80948-002-07	I	Inactivated by FDA	2026-10-05
excluded package	package	80948-002	80948-002-08	I	Inactivated by FDA	2026-10-05
excluded package	package	80948-002	80948-002-09	I	Inactivated by FDA	2026-10-05
excluded package	package	80948-002	80948-002-10	I	Inactivated by FDA	2026-10-05
excluded package	package	80948-002	80948-002-11	I	Inactivated by FDA	2026-10-05
excluded package	package	80948-002	80948-002-12	I	Inactivated by FDA	2026-10-05
excluded package	package	80948-002	80948-002-13	I	Inactivated by FDA	2026-10-05
excluded package	package	80948-002	80948-002-14	I	Inactivated by FDA	2026-10-05
excluded package	package	80948-002	80948-002-15	I	Inactivated by FDA	2026-10-05
excluded package	package	80948-002	80948-002-16	I	Inactivated by FDA	2026-10-05
excluded package	package	80948-002	80948-002-17	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 · 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	80948-002-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80948-002-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80948-002-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80948-002-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80948-002-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80948-002-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80948-002-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80948-002-17	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80948-002-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80948-002-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80948-002-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80948-002-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80948-002-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80948-002-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80948-002-13	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80948-002-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80948-002-16	`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	80948-002-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80948-002-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80948-002-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80948-002-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80948-002-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80948-002-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80948-002-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80948-002-17	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80948-002-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80948-002-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80948-002-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80948-002-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80948-002-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80948-002-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80948-002-13	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80948-002-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80948-002-16	`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	80948-002-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80948-002-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80948-002-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80948-002-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80948-002-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80948-002-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80948-002-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80948-002-17	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80948-002-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80948-002-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80948-002-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80948-002-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80948-002-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80948-002-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80948-002-13	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80948-002-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80948-002-16	`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	80948-002-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80948-002-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80948-002-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80948-002-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80948-002-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`

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
80948-002-01	PUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-02	PUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-03	PUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-04	PUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-05	PUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-06	PUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-07	PUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-08	PUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-09	PUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-10	PUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-11	PUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-12	PUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-13	PUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-14	PUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-15	PUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-16	PUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-17	PUROMA Ethyl Alcohol 70% Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
80948-002-01	PUROMA	30 mL in 1 BOTTLE	GEL	30	5
80948-002-02	PUROMA	60 mL in 1 BOTTLE	GEL	60	5
80948-002-03	PUROMA	50 mL in 1 BOTTLE	GEL	50	5
80948-002-04	PUROMA	100 mL in 1 BOTTLE	GEL	100	5
80948-002-05	PUROMA	120 mL in 1 BOTTLE	GEL	120	5
80948-002-06	PUROMA	320 mL in 1 BOTTLE	GEL	320	5
80948-002-07	PUROMA	503 mL in 1 BOTTLE	GEL	503	5
80948-002-08	PUROMA	5000 mL in 1 CAN	GEL	5000	5
80948-002-09	PUROMA	50000 mL in 1 CAN	GEL	50000	5
80948-002-10	PUROMA	200000 mL in 1 DRUM	GEL	200000	5
80948-002-11	PUROMA	30 mL in 1 BOTTLE	GEL	30	5
80948-002-11	PUROMA	12 in 1 PACKAGE	GEL	12	5
80948-002-12	PUROMA	6 in 1 PACKAGE	GEL	6	5
80948-002-12	PUROMA	60 mL in 1 BOTTLE	GEL	60	5
80948-002-13	PUROMA	4 in 1 PACKAGE	GEL	4	5
80948-002-13	PUROMA	237 mL in 1 BOTTLE	GEL	237	5
80948-002-14	PUROMA	237 mL in 1 BOTTLE	GEL	237	5
80948-002-15	PUROMA	488 mL in 1 BOTTLE	GEL	488	5
80948-002-16	PUROMA	488 mL in 1 BOTTLE	GEL	488	5
80948-002-16	PUROMA	2 in 1 PACKAGE	GEL	2	5
80948-002-17	PUROMA	947 mL in 1 BOTTLE	GEL	947	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80948-002	PUROMA (ALCOHOL) GEL [ZENITH MICRO CONTROL]	5	Legacy NDC, 21 package rows	20231214_8825ca11-1e99-491f-9dfc-a282ded85c96.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	8825ca11-1e99-491f-9dfc-a282ded85c96	5
581662	ethanol 0.7 ML/ML Topical Gel	SCD	8825ca11-1e99-491f-9dfc-a282ded85c96	5
581662	ethanol 70 % Topical Gel	SY	8825ca11-1e99-491f-9dfc-a282ded85c96	5
581662	ethyl alcohol 70 % Topical Gel	SY	8825ca11-1e99-491f-9dfc-a282ded85c96	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80948-002-01	80948000201	30 mL in 1 BOTTLE (80948-002-01)	30 ml	2020-12-20	0000-00-00	No	No	Current
80948-002-02	80948000202	60 mL in 1 BOTTLE (80948-002-02)	60 ml	2020-12-20	0000-00-00	No	No	Current
80948-002-03	80948000203	50 mL in 1 BOTTLE (80948-002-03)	50 ml	2020-12-20	0000-00-00	No	No	Current
80948-002-04	80948000204	100 mL in 1 BOTTLE (80948-002-04)	100 ml	2020-12-20	0000-00-00	No	No	Current
80948-002-05	80948000205	120 mL in 1 BOTTLE (80948-002-05)	120 ml	2020-12-20	0000-00-00	No	No	Current
80948-002-06	80948000206	320 mL in 1 BOTTLE (80948-002-06)	320 ml	2020-12-20	0000-00-00	No	No	Current
80948-002-07	80948000207	503 mL in 1 BOTTLE (80948-002-07)	503 ml	2020-12-20	0000-00-00	No	No	Current
80948-002-08	80948000208	5000 mL in 1 CAN (80948-002-08)	5000 ml	2020-12-20	0000-00-00	No	No	Current
80948-002-09	80948000209	50000 mL in 1 CAN (80948-002-09)	50000 ml	2020-12-20	0000-00-00	No	No	Current
80948-002-10	80948000210	200000 mL in 1 DRUM (80948-002-10)	200000 ml	2020-12-20	0000-00-00	No	No	Current
80948-002-11	80948000211	12 BOTTLE in 1 PACKAGE (80948-002-11) > 30 mL in 1 BOTTLE	12 bottle	2021-10-21	0000-00-00	No	No	Current
80948-002-12	80948000212	6 BOTTLE in 1 PACKAGE (80948-002-12) > 60 mL in 1 BOTTLE	6 bottle	2021-10-21	0000-00-00	No	No	Current
80948-002-13	80948000213	4 BOTTLE in 1 PACKAGE (80948-002-13) > 237 mL in 1 BOTTLE	4 bottle	2021-10-21	0000-00-00	No	No	Current
80948-002-14	80948000214	237 mL in 1 BOTTLE (80948-002-14)	237 ml	2021-10-21	0000-00-00	No	No	Current
80948-002-15	80948000215	488 mL in 1 BOTTLE (80948-002-15)	488 ml	2021-10-21	0000-00-00	No	No	Current
80948-002-16	80948000216	2 BOTTLE in 1 PACKAGE (80948-002-16) > 488 mL in 1 BOTTLE	2 bottle	2021-10-21	0000-00-00	No	No	Current
80948-002-17	80948000217	947 mL in 1 BOTTLE (80948-002-17)	947 ml	2021-10-21	0000-00-00	No	No	Current