EJECTDELAY

Product NDC: 57483-003
11-digit product format: 574830003
Labeler code: 57483
Product ID: 57483-003_d4d19065-51a3-4c21-a615-060a82546328
Type: HUMAN OTC DRUG
Nonproprietary name: Benzocaine 7.5%
Dosage form: GEL
Route: TOPICAL
Labeler: Innovus Pharmaceuticals, Inc.
Application: part333B
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2013-07-15
Marketing end: 0000-00-00
Substance: BENZOCAINE
Active strength: 8 g/100g
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	57483-003		I	Inactivated by FDA	2026-10-12
excluded product	product	57483-003		D	Discontinued by firm	2026-10-12
excluded package	package	57483-003	57483-003-07	I	Inactivated by FDA	2026-10-12
excluded package	package	57483-003	57483-003-08	I	Inactivated by FDA	2026-10-12
excluded package	package	57483-003	57483-003-02	D	Discontinued by firm	2026-10-12
excluded package	package	57483-003	57483-003-06	D	Discontinued by firm	2026-10-12

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 · 117 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		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
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	57483-003-07	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57483-003-02	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57483-003-06	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57483-003-08	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
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	57483-003-07	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57483-003-02	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57483-003-06	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57483-003-08	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
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	57483-003-07	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57483-003-02	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57483-003-06	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57483-003-08	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
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	57483-003-07	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57483-003-02	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57483-003-06	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57483-003-08	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
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	57483-003-07	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	57483-003-02	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	57483-003-06	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	57483-003-08	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
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	57483-003-07	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	57483-003-02	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	57483-003-06	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	57483-003-08	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57483-003-07	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57483-003-02	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57483-003-06	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57483-003-08	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57483-003-07	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57483-003-02	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57483-003-06	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57483-003-08	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57483-003-07	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57483-003-02	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57483-003-06	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57483-003-08	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	57483-003-07	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	57483-003-02	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	57483-003-06	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	57483-003-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`

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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDC	Effective	Indexing SPL	Related label
57483-003-02	2023-01-16	9d75b9d0-05f2-f424-e053-dadaa90a57ce	Drug Facts
57483-003-06	2023-01-16	9d75b9d0-05f2-f424-e053-dadaa90a57ce	Drug Facts
57483-003-02	2020-01-31	9d75b9d0-05f2-f424-e053-dadaa90a57ce	Drug Facts
57483-003-06	2020-01-31	9d75b9d0-05f2-f424-e053-dadaa90a57ce	Drug Facts
57483-003-07	2020-01-31	9d75b9d0-4f2d-f424-e053-dadaa90a57ce	Drug Facts
57483-003-08	2020-01-31	9d75b9d0-4f2d-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
57483-003-03	EJECTDELAYGel	56.8 g in 1 TUBE	GEL	56.8	7
57483-003-07	EJECTDELAYGel	1 in 1 BOX	GEL	1	7
57483-003-08	EJECTDELAYGel	5 g in 1 PACKET	GEL	5	7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Benzocaine	ACTIVE INGREDIENT	U3RSY48JW5	EJECTDELAY GEL (BENZOCAINE 7.5%) GEL [INNOVUS PHARMACEUTICALS, INC.]	9
Benzocaine	ACTIVE MOIETY	U3RSY48JW5	EJECTDELAY GEL (BENZOCAINE 7.5%) GEL [INNOVUS PHARMACEUTICALS, INC.]	9
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	EJECTDELAY GEL (BENZOCAINE 7.5%) GEL [INNOVUS PHARMACEUTICALS, INC.]	9
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	EJECTDELAY GEL (BENZOCAINE 7.5%) GEL [INNOVUS PHARMACEUTICALS, INC.]	9
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	EJECTDELAY GEL (BENZOCAINE 7.5%) GEL [INNOVUS PHARMACEUTICALS, INC.]	9
POLYETHYLENE GLYCOL 4000	INACTIVE INGREDIENT	4R4HFI6D95	EJECTDELAY GEL (BENZOCAINE 7.5%) GEL [INNOVUS PHARMACEUTICALS, INC.]	9
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	EJECTDELAY GEL (BENZOCAINE 7.5%) GEL [INNOVUS PHARMACEUTICALS, INC.]	9
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	EJECTDELAY GEL (BENZOCAINE 7.5%) GEL [INNOVUS PHARMACEUTICALS, INC.]	9
Water	INACTIVE INGREDIENT	059QF0KO0R	EJECTDELAY GEL (BENZOCAINE 7.5%) GEL [INNOVUS PHARMACEUTICALS, INC.]	9
Benzocaine	ACTIVE INGREDIENT	U3RSY48JW5	EJECTDELAY GEL (BENZOCAINE 7.5%) GEL [INNOVUS PHARMACEUTICALS, INC.]	7
Benzocaine	ACTIVE MOIETY	U3RSY48JW5	EJECTDELAY GEL (BENZOCAINE 7.5%) GEL [INNOVUS PHARMACEUTICALS, INC.]	7
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	EJECTDELAY GEL (BENZOCAINE 7.5%) GEL [INNOVUS PHARMACEUTICALS, INC.]	7
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	EJECTDELAY GEL (BENZOCAINE 7.5%) GEL [INNOVUS PHARMACEUTICALS, INC.]	7
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	EJECTDELAY GEL (BENZOCAINE 7.5%) GEL [INNOVUS PHARMACEUTICALS, INC.]	7
POLYETHYLENE GLYCOL 4000	INACTIVE INGREDIENT	4R4HFI6D95	EJECTDELAY GEL (BENZOCAINE 7.5%) GEL [INNOVUS PHARMACEUTICALS, INC.]	7
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	EJECTDELAY GEL (BENZOCAINE 7.5%) GEL [INNOVUS PHARMACEUTICALS, INC.]	7
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	EJECTDELAY GEL (BENZOCAINE 7.5%) GEL [INNOVUS PHARMACEUTICALS, INC.]	7
Water	INACTIVE INGREDIENT	059QF0KO0R	EJECTDELAY GEL (BENZOCAINE 7.5%) GEL [INNOVUS PHARMACEUTICALS, INC.]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57483-003	EJECTDELAY GEL (BENZOCAINE 7.5%) GEL [INNOVUS PHARMACEUTICALS, INC.]	7	Legacy NDC, 3 package rows	20131107_61874e60-14d6-49c4-ac29-a13bc74f216c.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U3RSY48JW5	BENZOCAINE	94-09-7	BENZOCAINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
57483-003-03	57483000303	56.8 g in 1 TUBE	56.8 g	Historical
57483-003-07	57483000307	1 in 1 BOX		Historical
57483-003-08	57483000308	5 g in 1 PACKET	5 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Innovus Pharmaceuticals, Inc. \| U.S. Pharmaceuticals, Inc.	2013-11-12	HUMAN OTC DRUG LABEL	9
Drug Facts	Innovus Pharmaceuticals, Inc. \| U.S. Pharmaceuticals, Inc.	2013-11-06	HUMAN OTC DRUG LABEL	7