PUROMA Instant Foaming Hand Sanitizer without Fragrance

Product NDC: 80948-012
11-digit product format: 809480012
Labeler code: 80948
Product ID: 80948-012_d964ff60-84df-5e14-e053-2a95a90a520c
Type: HUMAN OTC DRUG
Nonproprietary name: Alcohol
Dosage form: LIQUID
Route: TOPICAL
Labeler: ZENITH MICRO CONTROL
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2021-03-10
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 75 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 · 13 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	80948-012		I	Inactivated by FDA	2026-10-05
excluded package	package	80948-012	80948-012-01	I	Inactivated by FDA	2026-10-05
excluded package	package	80948-012	80948-012-02	I	Inactivated by FDA	2026-10-05
excluded package	package	80948-012	80948-012-03	I	Inactivated by FDA	2026-10-05
excluded package	package	80948-012	80948-012-04	I	Inactivated by FDA	2026-10-05
excluded package	package	80948-012	80948-012-05	I	Inactivated by FDA	2026-10-05
excluded package	package	80948-012	80948-012-06	I	Inactivated by FDA	2026-10-05
excluded package	package	80948-012	80948-012-07	I	Inactivated by FDA	2026-10-05
excluded package	package	80948-012	80948-012-08	I	Inactivated by FDA	2026-10-05
excluded package	package	80948-012	80948-012-09	I	Inactivated by FDA	2026-10-05
excluded package	package	80948-012	80948-012-10	I	Inactivated by FDA	2026-10-05
excluded package	package	80948-012	80948-012-11	I	Inactivated by FDA	2026-10-05
excluded package	package	80948-012	80948-012-12	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 2 · 117 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	80948-012-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80948-012-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80948-012-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80948-012-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80948-012-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80948-012-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80948-012-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80948-012-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80948-012-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80948-012-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80948-012-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80948-012-08	`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	80948-012-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80948-012-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80948-012-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80948-012-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80948-012-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80948-012-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80948-012-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80948-012-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80948-012-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80948-012-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80948-012-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80948-012-08	`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	80948-012-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80948-012-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80948-012-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80948-012-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80948-012-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80948-012-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80948-012-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80948-012-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80948-012-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80948-012-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80948-012-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80948-012-08	`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	80948-012-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80948-012-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80948-012-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80948-012-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80948-012-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80948-012-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80948-012-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80948-012-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80948-012-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80948-012-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80948-012-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80948-012-08	`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	80948-012-11	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80948-012-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80948-012-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80948-012-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80948-012-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80948-012-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80948-012-04	`cfe11265f3b6…`	`090c488252e2…`

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
80948-012-01	ae3d334f-66d7-49e3-b584-bebf1eae6ab4
80948-012-02	ae3d334f-66d7-49e3-b584-bebf1eae6ab4
80948-012-03	ae3d334f-66d7-49e3-b584-bebf1eae6ab4
80948-012-04	ae3d334f-66d7-49e3-b584-bebf1eae6ab4
80948-012-05	ae3d334f-66d7-49e3-b584-bebf1eae6ab4
80948-012-06	ae3d334f-66d7-49e3-b584-bebf1eae6ab4
80948-012-07	ae3d334f-66d7-49e3-b584-bebf1eae6ab4
80948-012-08	ae3d334f-66d7-49e3-b584-bebf1eae6ab4
80948-012-09	ae3d334f-66d7-49e3-b584-bebf1eae6ab4
80948-012-10	ae3d334f-66d7-49e3-b584-bebf1eae6ab4
80948-012-11	ae3d334f-66d7-49e3-b584-bebf1eae6ab4
80948-012-12	ae3d334f-66d7-49e3-b584-bebf1eae6ab4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
80948-012-01	PUROMA Instant Foaming Hand Sanitizer without Fragrance	60 mL in 1 BOTTLE	LIQUID	60	3
80948-012-02	PUROMA Instant Foaming Hand Sanitizer without Fragrance	80 mL in 1 BOTTLE	LIQUID	80	3
80948-012-03	PUROMA Instant Foaming Hand Sanitizer without Fragrance	100 mL in 1 BOTTLE	LIQUID	100	3
80948-012-04	PUROMA Instant Foaming Hand Sanitizer without Fragrance	150 mL in 1 BOTTLE	LIQUID	150	3
80948-012-05	PUROMA Instant Foaming Hand Sanitizer without Fragrance	220 mL in 1 PACKAGE	LIQUID	220	3
80948-012-06	PUROMA Instant Foaming Hand Sanitizer without Fragrance	250 mL in 1 BOTTLE	LIQUID	250	3
80948-012-07	PUROMA Instant Foaming Hand Sanitizer without Fragrance	300 mL in 1 BOTTLE	LIQUID	300	3
80948-012-08	PUROMA Instant Foaming Hand Sanitizer without Fragrance	350 mL in 1 BOTTLE	LIQUID	350	3
80948-012-09	PUROMA Instant Foaming Hand Sanitizer without Fragrance	5000 mL in 1 CAN	LIQUID	5000	3
80948-012-10	PUROMA Instant Foaming Hand Sanitizer without Fragrance	50000 mL in 1 CAN	LIQUID	50000	3
80948-012-11	PUROMA Instant Foaming Hand Sanitizer without Fragrance	200000 mL in 1 CAN	LIQUID	200000	3
80948-012-12	PUROMA Instant Foaming Hand Sanitizer without Fragrance	70 mL in 1 BOTTLE	LIQUID	70	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80948-012	PUROMA INSTANT FOAMING HAND SANITIZER WITHOUT FRAGRANCE (ALCOHOL) LIQUID [ZENITH MICRO CONTROL]	3	Legacy NDC, 12 package rows	20231215_ae3d334f-66d7-49e3-b584-bebf1eae6ab4.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
1098198	ethanol 75 % Topical Foam	PSN	ae3d334f-66d7-49e3-b584-bebf1eae6ab4	3
1098198	ethanol 0.75 ML/ML Topical Foam	SCD	ae3d334f-66d7-49e3-b584-bebf1eae6ab4	3
1098198	ethanol 75 % Topical Foam	SY	ae3d334f-66d7-49e3-b584-bebf1eae6ab4	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80948-012-01	80948001201	60 mL in 1 BOTTLE (80948-012-01)	60 ml	2021-04-06	0000-00-00	No	No	Current
80948-012-02	80948001202	80 mL in 1 BOTTLE (80948-012-02)	80 ml	2021-04-06	0000-00-00	No	No	Current
80948-012-03	80948001203	100 mL in 1 BOTTLE (80948-012-03)	100 ml	2021-04-06	0000-00-00	No	No	Current
80948-012-04	80948001204	150 mL in 1 BOTTLE (80948-012-04)	150 ml	2021-04-06	0000-00-00	No	No	Current
80948-012-05	80948001205	220 mL in 1 PACKAGE (80948-012-05)	220 ml	2021-04-06	0000-00-00	No	No	Current
80948-012-06	80948001206	250 mL in 1 BOTTLE (80948-012-06)	250 ml	2021-04-06	0000-00-00	No	No	Current
80948-012-07	80948001207	300 mL in 1 BOTTLE (80948-012-07)	300 ml	2021-04-06	0000-00-00	No	No	Current
80948-012-08	80948001208	350 mL in 1 BOTTLE (80948-012-08)	350 ml	2021-04-06	0000-00-00	No	No	Current
80948-012-09	80948001209	5000 mL in 1 CAN (80948-012-09)	5000 ml	2021-04-06	0000-00-00	No	No	Current
80948-012-10	80948001210	50000 mL in 1 CAN (80948-012-10)	50000 ml	2021-04-06	0000-00-00	No	No	Current
80948-012-11	80948001211	200000 mL in 1 CAN (80948-012-11)	200000 ml	2021-04-06	0000-00-00	No	No	Current
80948-012-12	80948001212	70 mL in 1 BOTTLE (80948-012-12)	70 ml	2022-03-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PUROMA Instant Foaming Hand Sanitizer without Fragrance - ZENITH MICRO CONTROL	ZENITH MICRO CONTROL	2023-12-14	HUMAN OTC DRUG LABEL	3