FDA.reportPublic FDA data

Stud 100 Male Genital Desensitizer

Product NDC
57707-050
11-digit product format
577070050
Labeler code
57707
Product ID
57707-050_51a754c9-5754-18ff-e063-6394a90a997f
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine
Dosage form
SPRAY, METERED
Route
TOPICAL
Labeler
Pound International Corp
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-03-13
Substance
LIDOCAINE
Active strength
9.6 mg/100mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Stud 100 Male Genital Desensitizer
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE9.6 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
98PI200987Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d075656e-b13f-4a1d-bbb6-501e642698d5Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2022-03-10Stud 100 Male Desensitizer
2022-03-10Stud 100 Male Desensitizer
2022-01-28Stud 100 Male Desensitizer
2022-01-28Stud 100 Male Desensitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57707-050-01Male Genital DesensitizerStud 10012.5 mL in 1 CANSPRAY, METERED12.527
57707-050-02Male Genital DesensitizerStud 1001 in 1 CARTONSPRAY, METERED127

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINEACTIVE INGREDIENT98PI200987MALE GENITAL DESENSITIZER STUD 100 (LIDOCANE) SPRAY, METERED [POUND INTERNATIONAL CORP]9
LIDOCAINEACTIVE MOIETY98PI200987MALE GENITAL DESENSITIZER STUD 100 (LIDOCANE) SPRAY, METERED [POUND INTERNATIONAL CORP]9
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSMALE GENITAL DESENSITIZER STUD 100 (LIDOCANE) SPRAY, METERED [POUND INTERNATIONAL CORP]9
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMALE GENITAL DESENSITIZER STUD 100 (LIDOCANE) SPRAY, METERED [POUND INTERNATIONAL CORP]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57707-050MALE GENITAL DESENSITIZER STUD 100 (LIDOCANE) SPRAY, METERED [POUND INTERNATIONAL CORP]27Current NDC, Legacy NDC, 2 package rows20250108_d075656e-b13f-4a1d-bbb6-501e642698d5.zip

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 141 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rite Aid Anti-itchHYDROCORTISONERite Aid0c540422-1579-9217-e063-6294a90ad06a2023-12-12WarningsExact identifier
application number: M017
Anti-itch Paraben FreeHYDROCORTISONEWeeks & Leo Co., Inc.0c5419c5-0929-7ca6-e063-6294a90ac0a72023-12-12WarningsExact identifier
application number: M017
Rite Aid HydrocortisoneHYDROCORTISONE 1%Rite Aid0c580f96-7fe9-19df-e063-6394a90a5a222023-12-12WarningsExact identifier
application number: M017
Anti itchHYDROCORTISONEWeeks & Leo Co., Inc.0c58b750-d3a6-5ed1-e063-6294a90a43212023-12-12WarningsExact identifier
application number: M017
Greencaine BlastLIDOCAINEALMA Laboratories, Inc.031e0065-4c8a-43d8-bc69-3efa3c6c0ae32023-12-12WarningsExact identifier
application number: M017
Ageless Pain ReliefMETHYL SALICYLATE, MENTHOLIsagenix International, LLC3c7e493b-923d-44b1-9076-46c7894308d42023-12-12Warnings, Adverse reactionsExact identifier
application number: M017
CVS Extra Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATECVS857af609-9dd7-a07a-e053-2991aa0ab6ba2023-12-11WarningsExact identifier
application number: M017
Rite Aid Extra Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATERite Aid0c4170dd-e1fa-d549-e063-6394a90a5c232023-12-11WarningsExact identifier
application number: M017
Westlake Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATEWestlake HB Pharma LLC0c416ba6-b01f-0609-e063-6294a90ae2a12023-12-11WarningsExact identifier
application number: M017
CVS Regular Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATECVS87473ace-d834-e43f-e053-2a95a90a819c2023-12-11WarningsExact identifier
application number: M017
Katinko External Analgesic OilCAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATEGreenstone Pharmaceutical Inc.5881fc35-3293-4f0b-801a-afcd6feb94962023-12-08WarningsExact identifier
application number: M017
Katinko Pain And Itch RelievingCAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATEGreenstone Pharmaceutical Inc.fe907fa4-4a01-4974-b71f-9cd980b4eaa22023-12-08Warnings, Adverse reactionsExact identifier
application number: M017
CycleMENTHOLLa Mend, Inc.cfc0bcde-ef91-1e6c-e053-2a95a90ab79e2023-12-07WarningsExact identifier
application number: M017
Hemorrhoidal Pain Relief CreamGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMWALGREENS03bbe146-f185-bcfa-e063-6394a90a85bf2023-12-04WarningsExact identifier
application number: M017
Quatriderm Anti-itchHYDROCORTISONEOPMX LLC83e59e10-9878-e5c2-e053-2a91aa0af25e2023-12-04WarningsExact identifier
application number: M017
TACTDIPHENHYDRAMINE HYDROCHLORIDE, MENTHOLSato Pharmaceutical Inc., Ltd.b6e2ee24-69de-4dfd-9081-b9537b7a7bad2023-12-04WarningsExact identifier
application number: M017
Overnight Cold Therapy Pain ReliefMENTHOL, UNSPECIFIED FORMWalgreen Co.2cbd0966-4cf9-4271-bd53-6672b1ed2a992023-12-04WarningsExact identifier
application number: M017
Prolayed Lidocaine Male Genital DesensitizerLIDOCAINEViaDerma Distribution, Inc.9c5ad0d0-ca7a-4321-9334-f06f3f6be18f2023-12-02WarningsExact identifier
application number: M017
Liberdol Topical AnalgesicMETHYL SALICYLATE, MENTHOL, CAMPHOR (SYNTHETIC)ViaDerma Distribution, Incab52cd0e-34fa-41c7-9ce7-1183c2aff8d82023-12-01WarningsExact identifier
application number: M017
ProlayedLIDOCAINEMATRIX MIXOLOGY, INCae317876-adb1-6d13-e053-2995a90a74af2023-12-01WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57707-050-015770700500112.5 mL in 1 CAN12.5 mlHistorical
57707-050-02577070050021 CAN in 1 CARTON (57707-050-02) / 12.5 mL in 1 CAN (57707-050-01) 1 can2013-03-130000-00-00NoNoCurrent