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 151 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EXOTEN-CMETHYL SALICYLATE, MENTHOL, CAPSAICINAsclemed USA, Inc.76ed37e0-64b5-4abe-a03c-3dc7084a39192023-10-16WarningsExact identifier
application number: M017
Calypxo Pain ReliefMETHYL SALICYLATE, MENTHOLAsclemed USA, Incbd9d0bc0-5705-4c73-bcd6-f6cdb68e05b62023-10-16WarningsExact identifier
application number: M017
Calypxo HP Pain ReliefMETHYL SALICYLATE, MENTHOLAsclemed USA, Inc89a8c267-bd92-4d0d-8e50-c52224aff9cd2023-10-16WarningsExact identifier
application number: M017
ZylotrolLIDOCAINE HCL 4%, MENTHOL 1%Whitestone Products LLC0e32e9c0-ff5b-4e88-89b1-f5903cd982092023-10-16WarningsExact identifier
application number: M017
CapsadynCAPSAICINChorda Pharma, Inc07731045-0d2b-76b7-e063-6294a90af9212023-10-11WarningsExact identifier
application number: M017
WHITE FLOWER STRAIN RELIEFCAMPHOR, MENTHOL AND METHYL SALICYLATEHOE HIN PAK FAH YEOW MANUFACTORY LTD65282267-de63-453a-a686-f8752c71b9ef2023-10-02WarningsExact identifier
application number: M017
WHITE FLOWER ANALGESIC BALM FLORAL SCENTEDCAMPHOR, MENTHOL AND METHYL SALICYLATEHOE HIN PAK FAH YEOW MANUFACTORY LTD4e9cb5aa-b0aa-4a5c-b561-cc38437758d82023-10-02WarningsExact identifier
application number: M017
NATUREANCE BODY BALMCAMPHOREROS GLOBAL CORP05b84fd2-8d8f-9249-e063-6294a90ae29f2023-09-19WarningsExact identifier
application number: M017
U ICE COLDMENTHOLUNIVERSAL DISTRIBUTION CENTER LLC752ef0cd-f12a-3b9e-e053-2991aa0abeb12023-09-01WarningsExact identifier
application number: M017
Family Wellness Pain Relief with LidocainePAIN RELIEF WITH LIDOCAINEFAMILY DOLLAR (Family Wellness)3a18119f-6c75-4cea-a990-97cb8a9589d42023-08-29WarningsExact identifier
application number: M017
Bactine Max Antibiotic and Lidocaine Max Pain ReliefLIDOCAINEWellSpring Pharmaceutical Corporation71300df9-6113-4f25-93ca-28ad7e7f79de2023-06-08WarningsExact identifier
application number: M017
Bactine Max Lidocaine Roll-on 2.5ozLIDOCAINEWellSpring Pharmaceutical Corporation09b32a98-9131-451e-87a6-81a1e4ed7ec52023-04-25WarningsExact identifier
application number: M017
Icy Hot Pro DryCAMPHOR, MENTHOLChattem, Inc.4de1bc29-d166-4599-9e75-5f841bf209672023-03-01WarningsExact identifier
application number: M017
Icy Hot Vanishing ScentMENTHOLChattem, Inc.e2092016-9741-433d-92e6-74bfddadb72c2022-09-29WarningsExact identifier
application number: M017
New TerocinMETHYL SALICYLATE, CAPSAICIN, AND MENTHOLAlexso, Inc5dbd5fc0-a27e-4979-aca7-28f73096fd5f2022-08-18WarningsExact identifier
application number: M017
FIRSTAR Sting Relief PadBENZOCAINEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.0e491a7a-4204-439f-862d-741cbc0be9fd2021-07-06WarningsExact identifier
application number: M017
Arthritis Relief GoodSenseTROLAMINE SALICYLATEGeiss, Destin & Dunn, Inca253730a-2187-07de-e053-2a95a90a98772020-04-02WarningsExact identifier
application number: M017
Aloe CortHYDROCORTISONETopiderm, Inc.789a6669-3320-4558-8d6f-ab255db50d8d2019-09-17WarningsExact identifier
application number: M017
Eagle Brand Medicated Roll On RefreshCAMPHOR, MENTHOLBorden Company (Private) Limited567b6820-fb52-630e-e063-6294a90a8bf82015-07-01WarningsExact identifier
application number: M017
Eagle Brand Medicated Oil AromaticCAMPHOR, MENTHOL, METHYL SALICYLATEBorden Company (Private) Limited54e45d89-e8c3-6fc3-e063-6394a90aac4e2015-06-15WarningsExact 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