PUROMA Hand Sanitizer Wipe Alcohol Free

Product NDC: 80948-011
11-digit product format: 809480011
Labeler code: 80948
Product ID: 80948-011_beb3ee97-d960-3a44-e053-2995a90ab260
Type: HUMAN OTC DRUG
Nonproprietary name: Benzalkonium chloride
Dosage form: CLOTH
Route: TOPICAL
Labeler: ZENITH MICRO CONTROL
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2021-03-12
Marketing end: 0000-00-00
Substance: BENZALKONIUM CHLORIDE
Active strength: 130 mg/100mL
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 8 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	80948-011		I	Inactivated by FDA	2026-10-05
excluded package	package	80948-011	80948-011-01	I	Inactivated by FDA	2026-10-05
excluded package	package	80948-011	80948-011-02	I	Inactivated by FDA	2026-10-05
excluded package	package	80948-011	80948-011-03	I	Inactivated by FDA	2026-10-05
excluded package	package	80948-011	80948-011-04	I	Inactivated by FDA	2026-10-05
excluded package	package	80948-011	80948-011-05	I	Inactivated by FDA	2026-10-05
excluded package	package	80948-011	80948-011-06	I	Inactivated by FDA	2026-10-05
excluded package	package	80948-011	80948-011-07	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 · 72 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80948-011-06	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80948-011-03	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80948-011-04	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80948-011-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80948-011-02	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80948-011-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80948-011-07	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80948-011-06	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80948-011-03	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80948-011-04	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80948-011-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80948-011-02	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80948-011-05	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80948-011-07	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80948-011-06	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80948-011-03	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80948-011-04	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80948-011-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80948-011-02	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80948-011-05	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80948-011-07	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80948-011-06	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80948-011-03	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80948-011-04	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80948-011-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80948-011-02	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80948-011-05	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80948-011-07	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80948-011-06	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80948-011-03	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80948-011-04	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80948-011-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80948-011-02	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80948-011-05	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80948-011-07	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80948-011-06	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80948-011-03	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80948-011-04	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80948-011-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80948-011-02	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80948-011-05	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80948-011-07	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	80948-011-05	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	80948-011-06	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	80948-011-04	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	80948-011-03	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	80948-011-02	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	80948-011-07	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	80948-011-01	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	80948-011-05	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	80948-011-06	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	80948-011-04	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`

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
d1c9d1af-bddd-448d-86f7-69052b7d5b47	Product name	1	20220627

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
80948-011-01	af8f7588-93f8-491d-8c2b-6ef31c199027
80948-011-02	af8f7588-93f8-491d-8c2b-6ef31c199027
80948-011-03	af8f7588-93f8-491d-8c2b-6ef31c199027
80948-011-04	af8f7588-93f8-491d-8c2b-6ef31c199027
80948-011-05	af8f7588-93f8-491d-8c2b-6ef31c199027
80948-011-06	af8f7588-93f8-491d-8c2b-6ef31c199027
80948-011-07	af8f7588-93f8-491d-8c2b-6ef31c199027

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
80948-011-01	PUROMA Hand Sanitizer Wipe Alcohol Free	66 mL in 1 PACKAGE	CLOTH	66	2
80948-011-01	PUROMA Hand Sanitizer Wipe Alcohol Free	10 in 1 PACKAGE	CLOTH	10	2
80948-011-02	PUROMA Hand Sanitizer Wipe Alcohol Free	132 mL in 1 PACKAGE	CLOTH	132	2
80948-011-02	PUROMA Hand Sanitizer Wipe Alcohol Free	20 in 1 PACKAGE	CLOTH	20	2
80948-011-03	PUROMA Hand Sanitizer Wipe Alcohol Free	40 in 1 PACKAGE	CLOTH	40	2
80948-011-03	PUROMA Hand Sanitizer Wipe Alcohol Free	264 mL in 1 PACKAGE	CLOTH	264	2
80948-011-04	PUROMA Hand Sanitizer Wipe Alcohol Free	80 in 1 PACKAGE	CLOTH	80	2
80948-011-04	PUROMA Hand Sanitizer Wipe Alcohol Free	528 mL in 1 PACKAGE	CLOTH	528	2
80948-011-05	PUROMA Hand Sanitizer Wipe Alcohol Free	120 in 1 PACKAGE	CLOTH	120	2
80948-011-05	PUROMA Hand Sanitizer Wipe Alcohol Free	792 mL in 1 PACKAGE	CLOTH	792	2
80948-011-06	PUROMA Hand Sanitizer Wipe Alcohol Free	350 mL in 1 CANISTER	CLOTH	350	2
80948-011-06	PUROMA Hand Sanitizer Wipe Alcohol Free	50 in 1 CANISTER	CLOTH	50	2
80948-011-07	PUROMA Hand Sanitizer Wipe Alcohol Free	700 mL in 1 CANISTER	CLOTH	700	2
80948-011-07	PUROMA Hand Sanitizer Wipe Alcohol Free	100 in 1 CANISTER	CLOTH	100	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80948-011	PUROMA HAND SANITIZER WIPE ALCOHOL FREE (BENZALKONIUM CHLORIDE) CLOTH [ZENITH MICRO CONTROL]	2	Legacy NDC, 14 package rows	20231215_af8f7588-93f8-491d-8c2b-6ef31c199027.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F5UM2KM3W7	BENZALKONIUM CHLORIDE	8001-54-5	BENZALKONIUM CHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1038558	benzalkonium chloride 0.13 % Medicated Pad	PSN	af8f7588-93f8-491d-8c2b-6ef31c199027	2
1038558	benzalkonium chloride 1.3 MG/ML Medicated Pad	SCD	af8f7588-93f8-491d-8c2b-6ef31c199027	2
1038558	benzalkonium chloride 0.13 % Topical Cloth	SY	af8f7588-93f8-491d-8c2b-6ef31c199027	2
1038558	benzalkonium chloride 0.13 % Topical Swab	SY	af8f7588-93f8-491d-8c2b-6ef31c199027	2
1038558	benzalkonium chloride 0.13 GM per 100 GM Topical Pad	SY	af8f7588-93f8-491d-8c2b-6ef31c199027	2
1038558	benzalkonium chloride 0.13 GM per 100 GM Topical Swab	SY	af8f7588-93f8-491d-8c2b-6ef31c199027	2
1038558	benzalkonium chloride 1 ML per 750 ML Topical Swab	SY	af8f7588-93f8-491d-8c2b-6ef31c199027	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80948-011-01	80948001101	10 PACKAGE in 1 PACKAGE (80948-011-01) > 66 mL in 1 PACKAGE	10 package	2021-03-12	0000-00-00	No	No	Current
80948-011-02	80948001102	20 PACKAGE in 1 PACKAGE (80948-011-02) > 132 mL in 1 PACKAGE	20 package	2021-03-12	0000-00-00	No	No	Current
80948-011-03	80948001103	40 PACKAGE in 1 PACKAGE (80948-011-03) > 264 mL in 1 PACKAGE	40 package	2021-03-12	0000-00-00	No	No	Current
80948-011-04	80948001104	80 PACKAGE in 1 PACKAGE (80948-011-04) > 528 mL in 1 PACKAGE	80 package	2021-03-12	0000-00-00	No	No	Current
80948-011-05	80948001105	120 PACKAGE in 1 PACKAGE (80948-011-05) > 792 mL in 1 PACKAGE	120 package	2021-03-12	0000-00-00	No	No	Current
80948-011-06	80948001106	50 CANISTER in 1 CANISTER (80948-011-06) > 350 mL in 1 CANISTER	50 canister	2021-03-12	0000-00-00	No	No	Current
80948-011-07	80948001107	100 CANISTER in 1 CANISTER (80948-011-07) > 700 mL in 1 CANISTER	100 canister	2021-03-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PUROMA Hand Sanitizer Wipe Alcohol Free - ZENITH MICRO CONTROL	ZENITH MICRO CONTROL	2023-12-14	HUMAN OTC DRUG LABEL	2