FDA.reportPublic FDA data

POWERECT Lidocaine Male Delay

Product NDC
81923-366
11-digit product format
819230366
Labeler code
81923
Product ID
81923-366_0976dfc5-c35a-11fe-e063-6294a90aa2bb
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
TOPICAL
Labeler
SKINS SEXUAL HEALTH LIMITED
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-10-03
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
10 mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
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
POWERECT Lidocaine Male Delay
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V13007Z41AInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
42e0c40f-1efd-45ef-815d-53d193d720ebAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
08c722ec-780f-bb7b-8f14-3d4f7bf0e098Product name220240205
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
e2f276e5-439f-b432-b5e5-b0cfa993da69Product name320220609
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
4585a4fb-0028-3d95-020c-9b1c40bf15e0Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81923-366-00POWERECT Lidocaine Male Delay15 mL in 1 BOTTLE, SPRAYSOLUTION152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81923-366POWERECT LIDOCAINE MALE DELAY (LIDOCAINE HYDROCHLORIDE) SOLUTION [SKINS SEXUAL HEALTH LIMITED]2Current NDC, Legacy NDC, 1 package rows20231106_42e0c40f-1efd-45ef-815d-53d193d720eb.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 56 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
T-Relief Lidocaine HCL 4%LIDOCAINE HCL 4%Medinatura New Mexico Inc.3c19aff8-fb18-78d0-e063-6294a90a94812025-12-11WarningsExact identifier
application number: M017
JointivaTROLAMINE SALICYLATE 10%Rising Pharma Holdings, Inc.3ee33cbf-7c0f-4982-b0b6-eeeb0202803b2025-12-11WarningsExact identifier
application number: M017
LMX4LIDOCAINEFerndale Laboratories, Inc.f0e7c92f-8b0b-4045-b659-af9f6e81260f2025-12-10WarningsExact identifier
application number: M017
HurriCaine OneTOPICAL ANESTHETIC AND ANTISEPTICBeutlich Pharmaceuticals LLC459cedbd-9b6f-e450-e063-6394a90afb732025-12-10WarningsExact identifier
application number: M017
AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 3NICOTINE TRANSDERMAL PATCHESPCHEERY LLC45811e83-8d0b-bc2a-e063-6294a90adf502025-12-09WarningsExact identifier
application number: M017
AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 2NICOTINE TRANSDERMAL PATCHESPCHEERY LLC4580d7f0-92a9-d0d0-e063-6394a90ac3932025-12-09WarningsExact identifier
application number: M017
LidoGuardLIDOCAINE HCLALAINA HEALTHCARE PRIVATE LIMITEDc339dffe-bc9b-4fae-a50f-8db463d244c12025-12-09WarningsExact identifier
application number: M017
Capsaicin Cream 0.075%CAPSAICINALAINA HEALTHCARE PRIVATE LIMITED33e861bd-bb92-4aea-9d4d-1b8847c794fd2025-12-09WarningsExact identifier
application number: M017
Methyl SalicylateMETHYL SALICYLATEALAINA HEALTHCARE PRIVATE LIMITEDe07c5ebc-5497-4c45-acc5-d12e72e98f3f2025-12-09WarningsExact identifier
application number: M017
Ultra Strength Pain Relief BalmCAMPHOR, MENTHOLALAINA HEALTHCARE PRIVATE LIMITED80779d1f-0c2a-4ae5-9ed7-eb6877f734ba2025-12-09WarningsExact identifier
application number: M017
Pain Relief BalmMENTHOL AND CAMPHORALAINA HEALTHCARE PRIVATE LIMITED12d76b8f-4b1d-4f2d-9722-0adb55093cc42025-12-09WarningsExact identifier
application number: M017
Trojan Extended PleasureBENZOCAINEChurch & Dwight Co., Inc.be731682-4174-649a-e053-2a95a90a39872025-12-09WarningsExact identifier
application number: M017
Stopain Clinical ContinuousMENTHOLTroy Manufacturing, Inc.65f8d212-0f0e-4893-b6af-bd68bba464432025-12-09WarningsExact identifier
application number: M017
Pain and Itch Relief 4% LidocaineLIDOCAINEWalgreensf84e76a9-6af6-4fd1-be4e-efa05728cbfd2025-12-09WarningsExact identifier
application number: M017
CapsimideCAPSAICIN 0.025% TOPICAL PATCHSola Pharmaceuticalse81c2de8-6429-d681-e053-2995a90a36a92025-12-08WarningsExact identifier
application number: M017
Extra Strength Cold-Hot Medicated PatchesMENTHOLCardinal Health, 110 dba LEADERa2895c03-747c-4220-8052-4f04280626222025-12-08WarningsExact identifier
application number: M017
Leader PAIN RELIEF PATCHESLIDOCAINECardinal Health, 110 dba LEADER5feae39e-3ab8-4cda-b9e8-dc221aea24172025-12-08WarningsExact identifier
application number: M017
Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATECardinal Health, 110 dba LEADERf8837b69-8d85-448c-a4b4-be911bca1f6c2025-12-08WarningsExact identifier
application number: M017
CAPSAICIN HOT PATCHESCAPSAICINCardinal Health, 110 dba LEADER76e6bc39-643c-4264-8d98-0e4fa7d778e22025-12-08WarningsExact identifier
application number: M017
Leader PAIN RELIEF PATCHESLIDOCAINECardinal Health, 110 dba LEADER3be6defd-f429-4dc7-8b37-5910705c0b812025-12-08WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81923-366-008192303660015 mL in 1 BOTTLE, SPRAY (81923-366-00) 15 ml2022-10-030000-00-00NoNoCurrent