FDA.reportPublic FDA data

NDC 57483-003-03 - EJECTDELAY Gel

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
57483-003
Requested NDC
57483-003-03
Package NDCs from labels
57483-003-03, 57483-003-02, 57483-003-06, 57483-003-07, 57483-003-08
Manufacturer
Innovus Pharmaceuticals, Inc. | U.S. Pharmaceuticals, Inc.
Effective date
2013-11-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
EJECTDELAY Gel - Innovus Pharmaceuticals, Inc. | U.S. Pharmaceuticals, Inc.Innovus Pharmaceuticals, Inc. | U.S. Pharmaceuticals, Inc.2013-11-12HUMAN OTC DRUG LABEL
EJECTDELAY Gel - Innovus Pharmaceuticals, Inc. | U.S. Pharmaceuticals, Inc.Innovus Pharmaceuticals, Inc. | U.S. Pharmaceuticals, Inc.2013-11-06HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDCEffectiveIndexing SPLRelated label
57483-003-022023-01-169d75b9d0-05f2-f424-e053-dadaa90a57ceDrug Facts
57483-003-062023-01-169d75b9d0-05f2-f424-e053-dadaa90a57ceDrug Facts
57483-003-022020-01-319d75b9d0-05f2-f424-e053-dadaa90a57ceDrug Facts
57483-003-062020-01-319d75b9d0-05f2-f424-e053-dadaa90a57ceDrug Facts
57483-003-072020-01-319d75b9d0-4f2d-f424-e053-dadaa90a57ceDrug Facts
57483-003-082020-01-319d75b9d0-4f2d-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57483-003-03EJECTDELAYGel56.8 g in 1 TUBEGEL56.87
57483-003-07EJECTDELAYGel1 in 1 BOXGEL17
57483-003-08EJECTDELAYGel5 g in 1 PACKETGEL57

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57483-003EJECTDELAY GEL (BENZOCAINE 7.5%) GEL [INNOVUS PHARMACEUTICALS, INC.]7Legacy NDC, 3 package rows20131107_61874e60-14d6-49c4-ac29-a13bc74f216c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BenzocaineACTIVE INGREDIENTU3RSY48JW5EJECTDELAY GEL (BENZOCAINE 7.5%) GEL [INNOVUS PHARMACEUTICALS, INC.]9
BenzocaineACTIVE MOIETYU3RSY48JW5EJECTDELAY GEL (BENZOCAINE 7.5%) GEL [INNOVUS PHARMACEUTICALS, INC.]9
GlycerinINACTIVE INGREDIENTPDC6A3C0OXEJECTDELAY GEL (BENZOCAINE 7.5%) GEL [INNOVUS PHARMACEUTICALS, INC.]9
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PEJECTDELAY GEL (BENZOCAINE 7.5%) GEL [INNOVUS PHARMACEUTICALS, INC.]9
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQEJECTDELAY GEL (BENZOCAINE 7.5%) GEL [INNOVUS PHARMACEUTICALS, INC.]9
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95EJECTDELAY GEL (BENZOCAINE 7.5%) GEL [INNOVUS PHARMACEUTICALS, INC.]9
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYEJECTDELAY GEL (BENZOCAINE 7.5%) GEL [INNOVUS PHARMACEUTICALS, INC.]9
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BEJECTDELAY GEL (BENZOCAINE 7.5%) GEL [INNOVUS PHARMACEUTICALS, INC.]9
WaterINACTIVE INGREDIENT059QF0KO0REJECTDELAY GEL (BENZOCAINE 7.5%) GEL [INNOVUS PHARMACEUTICALS, INC.]9
BenzocaineACTIVE INGREDIENTU3RSY48JW5EJECTDELAY GEL (BENZOCAINE 7.5%) GEL [INNOVUS PHARMACEUTICALS, INC.]7
BenzocaineACTIVE MOIETYU3RSY48JW5EJECTDELAY GEL (BENZOCAINE 7.5%) GEL [INNOVUS PHARMACEUTICALS, INC.]7
GlycerinINACTIVE INGREDIENTPDC6A3C0OXEJECTDELAY GEL (BENZOCAINE 7.5%) GEL [INNOVUS PHARMACEUTICALS, INC.]7
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PEJECTDELAY GEL (BENZOCAINE 7.5%) GEL [INNOVUS PHARMACEUTICALS, INC.]7
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQEJECTDELAY GEL (BENZOCAINE 7.5%) GEL [INNOVUS PHARMACEUTICALS, INC.]7
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95EJECTDELAY GEL (BENZOCAINE 7.5%) GEL [INNOVUS PHARMACEUTICALS, INC.]7
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYEJECTDELAY GEL (BENZOCAINE 7.5%) GEL [INNOVUS PHARMACEUTICALS, INC.]7
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BEJECTDELAY GEL (BENZOCAINE 7.5%) GEL [INNOVUS PHARMACEUTICALS, INC.]7
WaterINACTIVE INGREDIENT059QF0KO0REJECTDELAY GEL (BENZOCAINE 7.5%) GEL [INNOVUS PHARMACEUTICALS, INC.]7

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 61 · 1,214 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
leader clearlaxPOLYETHYLENE GLYCOL 3350Cardinal Health 110, LLC. dba Leader812c59b0-e7ce-4c7a-91ed-e74b7b1b84be2026-09-22WarningsExact identifier
unii: G2M7P15E5P
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350L.N.K. International, Inc.bbc11078-73f7-4d27-b0d3-4d4ae5dae2402026-09-10WarningsExact identifier
unii: G2M7P15E5P
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
CLEARLAXPOLYETHYLENE GLYCOL 3350Amazon.com Services LLC7ed915ec-7e99-4e0e-aca0-20718987a88c2026-09-08WarningsExact identifier
unii: G2M7P15E5P
Clear Eyes NighttimeGLYCERINPrestige Brands Holdings, Inc.af75e2f7-81dd-43e0-a390-b52bbfbebf622026-09-08WarningsExact identifier
unii: PDC6A3C0OX
Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO., LTD57ccc28b-5f5f-30ec-e063-6294a90a081c2026-09-07WarningsExact identifier
unii: U3RSY48JW5
purelaxPOLYETHYLENE GLYCOL 3350CVS Pharmacyfc3b6006-a75a-41b3-9f0b-a3152df1363f2026-09-04WarningsExact identifier
unii: G2M7P15E5P
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMCVS Pharmacy3167c918-a7d3-46a1-a85b-64f9c22916f22026-09-04WarningsExact identifier
unii: PDC6A3C0OX
Dr.Harry EYES PROTECTIONPOLYETHYLENE GLYCOL 400 1% EYES PROTECTIONWenzhou Yuyuan Pharmaceutical Co., Ltd.5a9fe033-89d3-da62-e063-6294a90a45032026-09-03WarningsExact identifier
unii: B697894SGQ
SurviveX Sting ReliefSTING RELIEF WIPEChangzhou Maokang Medical Products Co., Ltd.5a83b1f1-c8dc-cf07-e063-6394a90a20ca2026-09-03WarningsExact identifier
unii: U3RSY48JW5
basic care clearlaxPOLYETHYLENE GLYCOL 3350Amazon.com Services LLC1ccb8604-34f6-4e1e-beed-eb81d6aa7aef2026-09-03WarningsExact identifier
unii: G2M7P15E5P
purelaxPOLYETHYLENE GLYCOL 3350CVS Pharmacy006a9eca-400f-47f5-bee5-facf7034043e2026-09-02WarningsExact identifier
unii: G2M7P15E5P
KrogerPOLYETHYLENE GLYCOL 3350KROGER COMPANYc56271ff-703a-40c4-840f-1962798c9e422026-09-02WarningsExact identifier
unii: G2M7P15E5P
gentle laxPOLYETHYLENE GLYCOL 3350Kroger Company0d820dcc-440a-4036-86e9-fdb30cac95732026-09-01WarningsExact identifier
unii: G2M7P15E5P
CLEARLAXPOLYETHYLENE GLYCOL 3350Amazon.com Services LLCbd33463b-eb1a-41ed-92d1-f50d0923eb3b2026-08-31WarningsExact identifier
unii: G2M7P15E5P
Orajel 4X Medicated Toothache and Gum CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1c82b4-02b3-d456-e063-6294a90a16bb2026-08-31WarningsExact identifier
unii: U3RSY48JW5
Orajel 4X Medicated Toothache and Gum PM CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1cdaf4-3388-280c-e063-6294a90ac70f2026-08-31WarningsExact identifier
unii: U3RSY48JW5
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Cardinal Health 107, LLC4d524ace-9de5-4f62-9263-7cd88a36b67c2026-08-28WarningsExact identifier
unii: G2M7P15E5P
PEG3350POLYETHYLENE GLYCOL 3350Major Pharmaceuticals161629f6-6193-4712-bba7-7d5b174a93382026-08-28WarningsExact identifier
unii: G2M7P15E5P

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.