intimale benzocaine delay gel

Generic: benzocaine

Labeler: skins sexual health limited
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name intimale benzocaine delay gel
Generic Name benzocaine
Labeler skins sexual health limited
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

benzocaine 50 mg/mL

Manufacturer
SKINS SEXUAL HEALTH LIMITED

Identifiers & Regulatory

Product NDC 81923-369
Product ID 81923-369_0976eff9-48b9-1669-e063-6394a90a8240
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2022-10-03

Pharmacologic Class

Established (EPC)
standardized chemical allergen [epc]
Chemical Structure
allergens [cs]
Physiologic Effect
increased histamine release [pe] cell-mediated immunity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81923369
Hyphenated Format 81923-369

Supplemental Identifiers

UPC
0847878002701
UNII
U3RSY48JW5
NUI
N0000185508 N0000175629 N0000184306 M0000728

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name intimale benzocaine delay gel (source: ndc)
Generic Name benzocaine (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 15 mL in 1 BOTTLE (81923-369-00)
source: ndc

Packages (1)

81923-369-00 15 mL in 1 BOTTLE (81923-369-00)

Ingredients (1)

benzocaine (50 mg/mL)

Linked Drug Pages (1)

INTIMALE Benzocaine Delay Gel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "0976eff9-48b9-1669-e063-6394a90a8240", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728"], "upc": ["0847878002701"], "unii": ["U3RSY48JW5"], "spl_set_id": ["b845bfd5-ab73-495f-97ef-e959bc6311d9"], "pharm_class_cs": ["Allergens [CS]"], "pharm_class_pe": ["Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]"], "pharm_class_epc": ["Standardized Chemical Allergen [EPC]"], "manufacturer_name": ["SKINS SEXUAL HEALTH LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "15 mL in 1 BOTTLE (81923-369-00)", "package_ndc": "81923-369-00", "marketing_start_date": "20221003"}], "brand_name": "INTIMALE Benzocaine Delay Gel", "product_id": "81923-369_0976eff9-48b9-1669-e063-6394a90a8240", "dosage_form": "GEL", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Increased Histamine Release [PE]", "Standardized Chemical Allergen [EPC]"], "product_ndc": "81923-369", "generic_name": "BENZOCAINE", "labeler_name": "SKINS SEXUAL HEALTH LIMITED", "product_type": "HUMAN OTC DRUG", "brand_name_base": "INTIMALE Benzocaine Delay Gel", "active_ingredients": [{"name": "BENZOCAINE", "strength": "50 mg/mL"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20221003", "listing_expiration_date": "20261231"}