DuraShield Fragrance Free Hand Sanitizer

Product NDC: 78235-012
11-digit product format: 782350012
Labeler code: 78235
Product ID: 78235-012_33272bda-35d0-4d8b-b6d5-12f920da4df4
Type: HUMAN OTC DRUG
Nonproprietary name: benzalkonium chloride lotion
Dosage form: LOTION
Route: TOPICAL
Labeler: CK Polymers LLC
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-10-06
Marketing end: 0000-00-00
Substance: BENZALKONIUM CHLORIDE
Active strength: 0 mg/mL
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 · 9 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	78235-012		I	Inactivated by FDA	2026-10-05
excluded package	package	78235-012	78235-012-01	I	Inactivated by FDA	2026-10-05
excluded package	package	78235-012	78235-012-02	I	Inactivated by FDA	2026-10-05
excluded package	package	78235-012	78235-012-03	I	Inactivated by FDA	2026-10-05
excluded package	package	78235-012	78235-012-04	I	Inactivated by FDA	2026-10-05
excluded package	package	78235-012	78235-012-05	I	Inactivated by FDA	2026-10-05
excluded package	package	78235-012	78235-012-06	I	Inactivated by FDA	2026-10-05
excluded package	package	78235-012	78235-012-07	I	Inactivated by FDA	2026-10-05
excluded package	package	78235-012	78235-012-08	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 · 153 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	78235-012-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78235-012-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78235-012-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78235-012-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78235-012-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78235-012-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78235-012-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78235-012-01	`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	78235-012-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78235-012-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78235-012-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78235-012-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78235-012-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78235-012-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78235-012-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78235-012-01	`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	78235-012-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78235-012-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78235-012-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78235-012-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78235-012-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78235-012-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78235-012-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78235-012-01	`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	78235-012-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78235-012-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78235-012-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78235-012-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78235-012-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78235-012-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78235-012-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78235-012-01	`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	78235-012-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78235-012-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78235-012-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78235-012-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78235-012-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78235-012-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78235-012-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78235-012-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78235-012-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78235-012-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78235-012-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78235-012-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78235-012-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78235-012-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78235-012-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78235-012-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78235-012-08	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78235-012-06	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78235-012-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78235-012-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78235-012-02	`302b2466d912…`	`e7b80fea0513…`

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
baf7f49c-75b6-496b-a00e-8e766a8e4f03	Product name	1	20210127
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
78235-012-01	2023-07-28	DuraShield® Fragrance Free
78235-012-02	2023-07-28	DuraShield® Fragrance Free
78235-012-03	2023-07-28	DuraShield® Fragrance Free
78235-012-04	2023-07-28	DuraShield® Fragrance Free
78235-012-05	2023-07-28	DuraShield® Fragrance Free
78235-012-06	2023-07-28	DuraShield® Fragrance Free
78235-012-07	2023-07-28	DuraShield® Fragrance Free
78235-012-08	2023-07-28	DuraShield® Fragrance Free
78235-012-01	2022-04-20	DuraShield® Fragrance Free
78235-012-02	2022-04-20	DuraShield® Fragrance Free
78235-012-03	2022-04-20	DuraShield® Fragrance Free
78235-012-04	2022-04-20	DuraShield® Fragrance Free
78235-012-05	2022-04-20	DuraShield® Fragrance Free
78235-012-06	2022-04-20	DuraShield® Fragrance Free
78235-012-07	2022-04-20	DuraShield® Fragrance Free
78235-012-08	2022-04-20	DuraShield® Fragrance Free
78235-012-01	2022-01-28	DuraShield® Fragrance Free
78235-012-02	2022-01-28	DuraShield® Fragrance Free
78235-012-03	2022-01-28	DuraShield® Fragrance Free
78235-012-04	2022-01-28	DuraShield® Fragrance Free
78235-012-05	2022-01-28	DuraShield® Fragrance Free
78235-012-06	2022-01-28	DuraShield® Fragrance Free
78235-012-07	2022-01-28	DuraShield® Fragrance Free
78235-012-08	2022-01-28	DuraShield® Fragrance Free

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
78235-012-01	DuraShield Fragrance Free Hand Sanitizer	3785 mL in 1 JUG	LOTION	3785	4
78235-012-02	DuraShield Fragrance Free Hand Sanitizer	208175 mL in 1 DRUM	LOTION	208175	4
78235-012-03	DuraShield Fragrance Free Hand Sanitizer	18927.1 mL in 1 CONTAINER	LOTION	18927.1	4
78235-012-04	DuraShield Fragrance Free Hand Sanitizer	1249050 mL in 1 CONTAINER	LOTION	1249050	4
78235-012-05	DuraShield Fragrance Free Hand Sanitizer	1040875 mL in 1 CONTAINER	LOTION	1040875	4
78235-012-06	DuraShield Fragrance Free Hand Sanitizer	60 mL in 1 CONTAINER	LOTION	60	4
78235-012-07	DuraShield Fragrance Free Hand Sanitizer	118 mL in 1 CONTAINER	LOTION	118	4
78235-012-08	DuraShield Fragrance Free Hand Sanitizer	237 mL in 1 CONTAINER	LOTION	237	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78235-012	DURASHIELD FRAGRANCE FREE HAND SANITIZER (BENZALKONIUM CHLORIDE LOTION) LOTION [CK POLYMERS LLC]	4	Legacy NDC, 8 package rows	20220421_f2fee473-d3c0-4dfe-94dd-6314f5d49dd0.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
78235-012-01	78235001201	3785 mL in 1 JUG (78235-012-01)	3785 ml	2020-10-06	0000-00-00	No	No	Current
78235-012-02	78235001202	208175 mL in 1 DRUM (78235-012-02)	208175 ml	2020-10-06	0000-00-00	No	No	Current
78235-012-03	78235001203	18927.1 mL in 1 CONTAINER (78235-012-03)	18927.1 ml	2020-10-06	0000-00-00	No	No	Current
78235-012-04	78235001204	1249050 mL in 1 CONTAINER (78235-012-04)	1249050 ml	2020-10-06	0000-00-00	No	No	Current
78235-012-05	78235001205	1040875 mL in 1 CONTAINER (78235-012-05)	1040875 ml	2020-10-09	0000-00-00	No	No	Current
78235-012-06	78235001206	60 mL in 1 CONTAINER (78235-012-06)	60 ml	2020-10-09	0000-00-00	No	No	Current
78235-012-07	78235001207	118 mL in 1 CONTAINER (78235-012-07)	118 ml	2020-10-09	0000-00-00	No	No	Current
78235-012-08	78235001208	237 mL in 1 CONTAINER (78235-012-08)	237 ml	2020-10-09	0000-00-00	No	No	Current