PUROMA

Product NDC: 80948-002
Requested package NDC: 80948-002-04
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	80948-002	80948-002-04	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 1 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
80948-002-04	80948000204	100 mL in 1 BOTTLE (80948-002-04)	100 ml	2020-12-20	0000-00-00	No	No	Current