Clean31

Product NDC: 81300-100
11-digit product format: 813000100
Labeler code: 81300
Product ID: 81300-100_b8520048-48da-192b-e053-2995a90ab5c7
Type: HUMAN OTC DRUG
Nonproprietary name: Benzalkonium Chloride
Dosage form: LIQUID
Route: TOPICAL
Labeler: S3 Surface Solutions, LLC
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-12-08
Marketing end: 0000-00-00
Substance: BENZALKONIUM CHLORIDE
Active strength: 0 g/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 · 9 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	81300-100		I	Inactivated by FDA	2026-10-05
excluded package	package	81300-100	81300-100-01	I	Inactivated by FDA	2026-10-05
excluded package	package	81300-100	81300-100-02	I	Inactivated by FDA	2026-10-05
excluded package	package	81300-100	81300-100-03	I	Inactivated by FDA	2026-10-05
excluded package	package	81300-100	81300-100-04	I	Inactivated by FDA	2026-10-05
excluded package	package	81300-100	81300-100-05	I	Inactivated by FDA	2026-10-05
excluded package	package	81300-100	81300-100-06	I	Inactivated by FDA	2026-10-05
excluded package	package	81300-100	81300-100-07	I	Inactivated by FDA	2026-10-05
excluded package	package	81300-100	81300-100-08	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 · 144 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	81300-100-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	81300-100-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	81300-100-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	81300-100-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	81300-100-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	81300-100-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	81300-100-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	81300-100-02	`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	81300-100-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	81300-100-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	81300-100-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	81300-100-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	81300-100-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	81300-100-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	81300-100-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	81300-100-02	`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	81300-100-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	81300-100-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	81300-100-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	81300-100-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	81300-100-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	81300-100-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	81300-100-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	81300-100-02	`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	81300-100-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	81300-100-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	81300-100-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	81300-100-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	81300-100-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	81300-100-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	81300-100-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	81300-100-02	`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	81300-100-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	81300-100-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	81300-100-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	81300-100-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	81300-100-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	81300-100-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	81300-100-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	81300-100-02	`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	81300-100-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	81300-100-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	81300-100-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	81300-100-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	81300-100-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	81300-100-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	81300-100-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	81300-100-02	`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	81300-100-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	81300-100-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	81300-100-08	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	81300-100-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	81300-100-04	`302b2466d912…`	`e7b80fea0513…`

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
81300-100-01	b5f84376-1f92-ebe6-e053-2a95a90a821e
81300-100-02	b5f84376-1f92-ebe6-e053-2a95a90a821e
81300-100-03	b5f84376-1f92-ebe6-e053-2a95a90a821e
81300-100-04	b5f84376-1f92-ebe6-e053-2a95a90a821e
81300-100-05	b5f84376-1f92-ebe6-e053-2a95a90a821e
81300-100-06	b5f84376-1f92-ebe6-e053-2a95a90a821e
81300-100-07	b5f84376-1f92-ebe6-e053-2a95a90a821e
81300-100-08	b5f84376-1f92-ebe6-e053-2a95a90a821e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
81300-100-01	Clean31	50 mL in 1 BOTTLE, PUMP	LIQUID	50	2
81300-100-02	Clean31	500 mL in 1 BOTTLE	LIQUID	500	2
81300-100-03	Clean31	1000 mL in 1 BOTTLE	LIQUID	1000	2
81300-100-04	Clean31	1000 mL in 1 BOTTLE, SPRAY	LIQUID	1000	2
81300-100-05	Clean31	3785.41 mL in 1 JUG	LIQUID	3785.41	2
81300-100-06	Clean31	18927.1 mL in 1 PAIL	LIQUID	18927.1	2
81300-100-07	Clean31	208198 mL in 1 DRUM	LIQUID	208198	2
81300-100-08	Clean31	1249000 mL in 1 CONTAINER	LIQUID	1249000	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81300-100	CLEAN31 (BENZALKONIUM CHLORIDE) LIQUID [S3 SURFACE SOLUTIONS, LLC]	2	Legacy NDC, 8 package rows	20210108_b5f84376-1f92-ebe6-e053-2a95a90a821e.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
1049254	benzalkonium chloride 0.13 % Topical Solution	PSN	b5f84376-1f92-ebe6-e053-2a95a90a821e	2
1049254	benzalkonium chloride 1.3 MG/ML Topical Solution	SCD	b5f84376-1f92-ebe6-e053-2a95a90a821e	2
1049254	benzalkonium chloride 0.13 % Topical Solution	SY	b5f84376-1f92-ebe6-e053-2a95a90a821e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
81300-100-01	81300010001	50 mL in 1 BOTTLE, PUMP (81300-100-01)	50 ml	2020-12-08	0000-00-00	No	No	Current
81300-100-02	81300010002	500 mL in 1 BOTTLE (81300-100-02)	500 ml	2020-12-08	0000-00-00	No	No	Current
81300-100-03	81300010003	1000 mL in 1 BOTTLE (81300-100-03)	1000 ml	2020-12-08	0000-00-00	No	No	Current
81300-100-04	81300010004	1000 mL in 1 BOTTLE, SPRAY (81300-100-04)	1000 ml	2020-12-08	0000-00-00	No	No	Current
81300-100-05	81300010005	3785.41 mL in 1 JUG (81300-100-05)	3785.41 ml	2020-12-08	0000-00-00	No	No	Current
81300-100-06	81300010006	18927.1 mL in 1 PAIL (81300-100-06)	18927.1 ml	2020-12-08	0000-00-00	No	No	Current
81300-100-07	81300010007	208198 mL in 1 DRUM (81300-100-07)	208198 ml	2020-12-08	0000-00-00	No	No	Current
81300-100-08	81300010008	1249000 mL in 1 CONTAINER (81300-100-08)	1249000 ml	2020-12-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clean31 - S3 Surface Solutions, LLC \| Polyventive LLC \| Guide Energy Solutions \| Emerald 66 Enterprises LLC	S3 Surface Solutions, LLC \| Polyventive LLC \| Guide Energy Solutions \| Emerald 66 Enterprises LLC	2021-01-07	HUMAN OTC DRUG LABEL	2