POWERECT Benzocaine Male Delay Gel

Product NDC
81923-367
11-digit product format
819230367
Labeler code
81923
Product ID
81923-367_1d5bbd54-69df-3338-e063-6294a90a53bf
Type
HUMAN OTC DRUG
Nonproprietary name
BENZOCAINE
Dosage form
GEL
Route
TOPICAL
Labeler
SKINS SEXUAL HEALTH LIMITED
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-10-03
Substance
BENZOCAINE
Active strength
50 mg/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
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 Benzocaine Male Delay Gel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U3RSY48JW5Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2fafe1f2-a31e-4b2a-bc51-81e16b319c3aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81923-367-00POWERECT Benzocaine Male Delay Gel3 mL in 1 PACKETGEL33
81923-367-01POWERECT Benzocaine Male Delay Gel15 mL in 1 BOTTLEGEL153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81923-367POWERECT BENZOCAINE MALE DELAY GEL (BENZOCAINE) GEL [SKINS SEXUAL HEALTH LIMITED]3Current NDC, Legacy NDC, 2 package rows20240717_2fafe1f2-a31e-4b2a-bc51-81e16b319c3a.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 146 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUPER BLUE STUFF Pain Relief CreamMENTHOLBLUE SPRING WELLNESS, L.L.C.066a2106-2e25-4df6-9a8d-4417ba1902052023-11-10WarningsExact identifier
application number: M017
INVIGO FLEX Pain Relief GelMENTHOLWYNNPHARM INC.909e1d8c-c517-4d6a-8682-894f042c00f82023-11-10WarningsExact identifier
application number: M017
ARNIMAX Penetrating Pain Relief GelMENTHOLWYNNPHARM INC.3a31f805-19c6-4036-a663-ebef9b2120072023-11-10WarningsExact identifier
application number: M017
KERA HCHYDROCORTISONEClinical Therapeutic Solutionsac215c8f-b224-480c-9295-3a34316293ba2023-11-10WarningsExact identifier
application number: M017
ALO THERAPEUTIC MASSAGE PAIN RELIEVINGMENTHOL, HISTAMINE DIHYDROCHLORIDETheraplex Solutionsda004500-5e48-487b-b96f-520a3094096c2023-11-10WarningsExact identifier
application number: M017
Osteo Bi-Flex JOINT HEALTH PAIN RELIEVINGMENTHOL, METHYL SALICYLATERexall Sundown, LLC55c55f1c-d2b3-6363-e054-00144ff88e882023-11-10WarningsExact identifier
application number: M017
NEUROFLEX Topical Pain Relieving LiquidCAMPHOR (SYNTHETIC), MENTHOLAlmark Products Inc6da3aa84-7a01-4041-8792-a4bbf49e6e4e2023-11-10WarningsExact identifier
application number: M017
SMOOTH GATOR 60-second Pain ReliefCAMPHOR (SYNTHETIC), MENTHOLSmooth Gator LLC3b74b542-202f-469e-8025-4372e95e6b012023-11-10WarningsExact identifier
application number: M017
Alo Therapeutic MassageMENTHOL, HISTAMINE DIHYDROCHLORIDECMI Therapy Solutions40f8b8d1-a20b-54b0-e054-00144ff88e882023-11-10WarningsExact identifier
application number: M017
Alo Therapeutic MassageMENTHOL, HISTAMINE DIHYDROCHLORIDECMI Therapy Solutions40f92e71-fe2e-16f4-e054-00144ff8d46c2023-11-10WarningsExact identifier
application number: M017
Teeter Renew Muscles Pain RelievingMETHYL SALICYLATE, MENTHOLSTL International INCb90dc5b9-c31d-4770-a291-98d036ae87232023-11-10WarningsExact identifier
application number: M017
SMOOTH GATOR Foot and Leg RubCAMPHOR (SYNTHETIC), MENTHOLSmooth Gator LLC57094238-506b-48c1-8eb9-fe904be80df02023-11-10WarningsExact identifier
application number: M017
SKIN A COOL Hydrocortisone Anti-ItchHYDROCORTISONEAna-Cool, LLCe3ea7406-e494-4038-9b28-8d0a28b4b8342023-11-10WarningsExact identifier
application number: M017
Teeter reNEW MUSCLES Pain RelievingMETHYL SALICYLATE, MENTHOLSTL International INCebc777b0-d141-4a62-9366-d14787eaefe02023-11-10WarningsExact identifier
application number: M017
FEELGOOD LAB Natural Pain CreamMENTHOLThe Feel Good Lab, LLC799d464c-aaf1-429a-877b-2a692397bb492023-11-10WarningsExact identifier
application number: M017
HIGHER CONTROL Male Climax Control LubricatingBENZOCAINEProduct Max Group Inc5f5fd127-34c5-403a-aa95-c9874ae794922023-11-10WarningsExact identifier
application number: M017
Alo Therapeutic MassageMENTHOL, HISTAMINE DIHYDROCHLORIDECMI Therapy Solutions40f93076-1f68-58e6-e054-00144ff88e882023-11-10WarningsExact identifier
application number: M017
Alo Therapeutic MassageMENTHOL, HISTAMINE DIHYDROCHLORIDECMI Therapy Solutions40f9622e-27c7-6a5d-e054-00144ff88e882023-11-10WarningsExact identifier
application number: M017
FEEL GOOD LAB Natural Pain CreamMENTHOLTHE FEEL GOOD LAB, LLC774a72b1-b719-4217-846e-7f9921fd1b162023-11-10WarningsExact identifier
application number: M017
BODY ACTION PRODUCTS Climax Control GelBENZOCAINEPRODUCT MAX GROUP INC53e746cc-0078-4381-bf0b-9c8f98d669042023-11-10WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81923-367-00819230367003 mL in 1 PACKET (81923-367-00) 3 ml2022-10-030000-00-00NoNoCurrent
81923-367-018192303670115 mL in 1 BOTTLE (81923-367-01) 15 ml2022-10-030000-00-00NoNoCurrent