CICLOFERON

Product NDC: 75940-122
11-digit product format: 759400122
Labeler code: 75940
Product ID: 75940-122_28277214-5f33-4222-b73b-0858aa08adc7
Type: HUMAN OTC DRUG
Nonproprietary name: benzalkonium chloride and lidocaine hydrochloride
Dosage form: GEL
Route: TOPICAL
Labeler: MarcasUSA LLC
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2011-08-01
Marketing end: 0000-00-00
Substance: BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE
Active strength: 1 mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	75940-122		I	Inactivated by FDA	2026-10-05
excluded package	package	75940-122	75940-122-02	I	Inactivated by FDA	2026-10-05
excluded package	package	75940-122	75940-122-04	I	Inactivated by FDA	2026-10-05
excluded package	package	75940-122	75940-122-05	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 · 80 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	75940-122-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75940-122-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75940-122-04	`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	75940-122-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75940-122-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75940-122-04	`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	75940-122-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75940-122-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75940-122-04	`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	75940-122-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75940-122-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75940-122-04	`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	75940-122-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	75940-122-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	75940-122-04	`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	75940-122-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	75940-122-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	75940-122-04	`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	75940-122-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	75940-122-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	75940-122-04	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	75940-122-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	75940-122-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	75940-122-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	75940-122-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	75940-122-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	75940-122-04	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	75940-122-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	75940-122-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	75940-122-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	75940-122-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	75940-122-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	75940-122-04	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	75940-122-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	75940-122-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	75940-122-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	75940-122-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	75940-122-05	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	75940-122-04	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	75940-122-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	75940-122-05	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	75940-122-04	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	75940-122-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	75940-122-05	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	75940-122-04	`1332a3947898…`	`d4bfe170f9cd…`

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
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
eaba870a-6a9d-442e-8643-87b3f558a451	Product name	1	20250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
332d03e4-aa24-4b11-841a-02bf41081920	Product name	1	20171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
68ed98f8-24c2-44a0-944a-6d36e82ce25a	Product name	1	20141222
1cd42bc2-a430-c72b-636d-991b235fbf80	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
75940-122-02	2020-09-27	Drug Facts
75940-122-04	2020-09-27	Drug Facts
75940-122-05	2020-09-27	Drug Facts
75940-122-02	2020-09-25	Drug Facts
75940-122-04	2020-09-25	Drug Facts
75940-122-05	2020-09-25	Drug Facts
75940-122-02	2020-07-22	Drug Facts
75940-122-04	2020-07-22	Drug Facts
75940-122-05	2020-07-22	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
75940-122-02	CICLOFERON	1 in 1 CARTON	GEL	1	7
75940-122-02	CICLOFERON	2 g in 1 TUBE	GEL	2	7
75940-122-04	CICLOFERON	4 g in 1 TUBE	GEL	4	7
75940-122-04	CICLOFERON	1 in 1 CARTON	GEL	1	7
75940-122-05	CICLOFERON	4 g in 1 TUBE	GEL	4	7
75940-122-05	CICLOFERON	1 in 1 CONTAINER	GEL	1	7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZALKONIUM CHLORIDE	ACTIVE INGREDIENT	F5UM2KM3W7	CICLOFERON (BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE) GEL [MARCASUSA LLC]	5
LIDOCAINE HYDROCHLORIDE	ACTIVE INGREDIENT	V13007Z41A	CICLOFERON (BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE) GEL [MARCASUSA LLC]	5
BENZALKONIUM	ACTIVE MOIETY	7N6JUD5X6Y	CICLOFERON (BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE) GEL [MARCASUSA LLC]	5
LIDOCAINE	ACTIVE MOIETY	98PI200987	CICLOFERON (BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE) GEL [MARCASUSA LLC]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CICLOFERON (BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE) GEL [MARCASUSA LLC]	5
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	CICLOFERON (BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE) GEL [MARCASUSA LLC]	5
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	CICLOFERON (BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE) GEL [MARCASUSA LLC]	5
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CICLOFERON (BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE) GEL [MARCASUSA LLC]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	CICLOFERON (BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE) GEL [MARCASUSA LLC]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75940-122	CICLOFERON (BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE) GEL [MARCASUSA LLC]	7	Legacy NDC, 6 package rows	20191220_e2c62b5f-56ee-4d04-9c19-26849fe2b2b1.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F5UM2KM3W7	BENZALKONIUM CHLORIDE	8001-54-5	BENZALKONIUM CHLORIDE
V13007Z41A	LIDOCAINE HYDROCHLORIDE	6108-05-0	LIDOCAINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1431682	benzalkonium chloride 0.13 % / lidocaine HCl 2 % Topical Gel	PSN	e2c62b5f-56ee-4d04-9c19-26849fe2b2b1	7
1431687	CICLOFERON 0.13 % / 2 % Topical Gel	PSN	e2c62b5f-56ee-4d04-9c19-26849fe2b2b1	7
1431687	benzalkonium chloride 0.0013 MG/MG / lidocaine hydrochloride 0.02 MG/MG Topical Gel [Cicloferon]	SBD	e2c62b5f-56ee-4d04-9c19-26849fe2b2b1	7
1431682	benzalkonium chloride 0.0013 MG/MG / lidocaine hydrochloride 0.02 MG/MG Topical Gel	SCD	e2c62b5f-56ee-4d04-9c19-26849fe2b2b1	7
1431682	benzalkonium chloride 0.13 % / lidocaine hydrochloride 2 % Topical Gel	SY	e2c62b5f-56ee-4d04-9c19-26849fe2b2b1	7
1431687	Cicloferon (benzalkonium chloride 0.13 % / lidocaine hydrochloride 2 % ) Topical Gel	SY	e2c62b5f-56ee-4d04-9c19-26849fe2b2b1	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
75940-122-02	75940012202	1 in 1 CARTON		Historical
75940-122-04	75940012204	4 g in 1 TUBE	4 g	Historical
75940-122-05	75940012205	4 g in 1 TUBE	4 g	Historical