DuraShield Original Scent Hand Sanitizer

Product NDC: 78235-011
11-digit product format: 782350011
Labeler code: 78235
Product ID: 78235-011_3945b000-e039-4b40-a865-61243ae42aa6
Type: HUMAN OTC DRUG
Nonproprietary name: Safe and Silky Fragrance HS
Dosage form: LOTION
Route: TOPICAL
Labeler: CK Polymers LLC
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-10-08
Marketing end: 0000-00-00
Substance: BENZALKONIUM CHLORIDE
Active strength: 1 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	78235-011		I	Inactivated by FDA	2026-10-05
excluded package	package	78235-011	78235-011-01	I	Inactivated by FDA	2026-10-05
excluded package	package	78235-011	78235-011-02	I	Inactivated by FDA	2026-10-05
excluded package	package	78235-011	78235-011-03	I	Inactivated by FDA	2026-10-05
excluded package	package	78235-011	78235-011-04	I	Inactivated by FDA	2026-10-05
excluded package	package	78235-011	78235-011-05	I	Inactivated by FDA	2026-10-05
excluded package	package	78235-011	78235-011-06	I	Inactivated by FDA	2026-10-05
excluded package	package	78235-011	78235-011-07	I	Inactivated by FDA	2026-10-05
excluded package	package	78235-011	78235-011-08	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	78235-011-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78235-011-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78235-011-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78235-011-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78235-011-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78235-011-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78235-011-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78235-011-05	`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	78235-011-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78235-011-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78235-011-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78235-011-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78235-011-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78235-011-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78235-011-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78235-011-05	`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	78235-011-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78235-011-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78235-011-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78235-011-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78235-011-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78235-011-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78235-011-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78235-011-05	`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	78235-011-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78235-011-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78235-011-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78235-011-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78235-011-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78235-011-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78235-011-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78235-011-05	`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	78235-011-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78235-011-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78235-011-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78235-011-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78235-011-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78235-011-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78235-011-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78235-011-05	`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	78235-011-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78235-011-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78235-011-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78235-011-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78235-011-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78235-011-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78235-011-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78235-011-05	`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	78235-011-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78235-011-07	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78235-011-06	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78235-011-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78235-011-04	`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
78235-011-01	2023-07-28	DuraShield® Original Scent
78235-011-02	2023-07-28	DuraShield® Original Scent
78235-011-03	2023-07-28	DuraShield® Original Scent
78235-011-04	2023-07-28	DuraShield® Original Scent
78235-011-05	2023-07-28	DuraShield® Original Scent
78235-011-06	2023-07-28	DuraShield® Original Scent
78235-011-07	2023-07-28	DuraShield® Original Scent
78235-011-08	2023-07-28	DuraShield® Original Scent
78235-011-01	2022-04-20	DuraShield® Original Scent
78235-011-02	2022-04-20	DuraShield® Original Scent
78235-011-03	2022-04-20	DuraShield® Original Scent
78235-011-04	2022-04-20	DuraShield® Original Scent
78235-011-05	2022-04-20	DuraShield® Original Scent
78235-011-06	2022-04-20	DuraShield® Original Scent
78235-011-07	2022-04-20	DuraShield® Original Scent
78235-011-08	2022-04-20	DuraShield® Original Scent
78235-011-01	2022-01-28	DuraShield® Original Scent
78235-011-02	2022-01-28	DuraShield® Original Scent
78235-011-03	2022-01-28	DuraShield® Original Scent
78235-011-04	2022-01-28	DuraShield® Original Scent
78235-011-05	2022-01-28	DuraShield® Original Scent
78235-011-06	2022-01-28	DuraShield® Original Scent
78235-011-07	2022-01-28	DuraShield® Original Scent
78235-011-08	2022-01-28	DuraShield® Original Scent

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
78235-011-01	DuraShield Original Scent Hand Sanitizer	3780 mL in 1 JUG	LOTION	3780	6
78235-011-02	DuraShield Original Scent Hand Sanitizer	208190 mL in 1 DRUM	LOTION	208190	6
78235-011-03	DuraShield Original Scent Hand Sanitizer	18927.1 mL in 1 CONTAINER	LOTION	18927.1	6
78235-011-04	DuraShield Original Scent Hand Sanitizer	1249190 mL in 1 CONTAINER	LOTION	1249190	6
78235-011-05	DuraShield Original Scent Hand Sanitizer	1040990 mL in 1 CONTAINER	LOTION	1040990	6
78235-011-06	DuraShield Original Scent Hand Sanitizer	60 mL in 1 BOTTLE	LOTION	60	6
78235-011-07	DuraShield Original Scent Hand Sanitizer	120 mL in 1 BOTTLE	LOTION	120	6
78235-011-08	DuraShield Original Scent Hand Sanitizer	240 mL in 1 BOTTLE	LOTION	240	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78235-011	DURASHIELD ORIGINAL SCENT HAND SANITIZER (SAFE AND SILKY FRAGRANCE HS) LOTION [CK POLYMERS LLC]	6	Legacy NDC, 8 package rows	20220421_47c64b60-8400-4e3d-a361-be3026a2374d.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
1046442	benzalkonium chloride 0.13 % Topical Lotion	PSN	47c64b60-8400-4e3d-a361-be3026a2374d	6
1046442	benzalkonium chloride 1.3 MG/ML Topical Lotion	SCD	47c64b60-8400-4e3d-a361-be3026a2374d	6
1046442	benzalkonium chloride 0.13 % Topical Lotion	SY	47c64b60-8400-4e3d-a361-be3026a2374d	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
78235-011-01	78235001101	3780 mL in 1 JUG (78235-011-01)	3780 ml	2020-10-08	0000-00-00	No	No	Current
78235-011-02	78235001102	208190 mL in 1 DRUM (78235-011-02)	208190 ml	2020-10-08	0000-00-00	No	No	Current
78235-011-03	78235001103	18927.1 mL in 1 CONTAINER (78235-011-03)	18927.1 ml	2020-10-08	0000-00-00	No	No	Current
78235-011-04	78235001104	1249190 mL in 1 CONTAINER (78235-011-04)	1249190 ml	2020-10-08	0000-00-00	No	No	Current
78235-011-05	78235001105	1040990 mL in 1 CONTAINER (78235-011-05)	1040990 ml	2020-10-08	0000-00-00	No	No	Current
78235-011-06	78235001106	60 mL in 1 BOTTLE (78235-011-06)	60 ml	2020-10-08	0000-00-00	No	No	Current
78235-011-07	78235001107	120 mL in 1 BOTTLE (78235-011-07)	120 ml	2020-10-08	0000-00-00	No	No	Current
78235-011-08	78235001108	240 mL in 1 BOTTLE (78235-011-08)	240 ml	2020-10-08	0000-00-00	No	No	Current