sta-hard

Generic: desensitizing lubricant

Labeler: novelties by nasswalk, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name sta-hard
Generic Name desensitizing lubricant
Labeler novelties by nasswalk, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

benzocaine 5 g/100mL

Manufacturer
Novelties by Nasswalk, Inc.

Identifiers & Regulatory

Product NDC 83608-102
Product ID 83608-102_434a875b-2593-3b30-e063-6294a90a9518
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2023-08-07

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 83608102
Hyphenated Format 83608-102

Supplemental Identifiers

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 sta-hard (source: ndc)
Generic Name desensitizing lubricant (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 5 g/100mL
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (83608-102-02) / .5 mL in 1 TUBE
  • 1 TUBE in 1 CARTON (83608-102-05) / .5 mL in 1 TUBE
  • 1 TUBE in 1 CARTON (83608-102-15) / 1.5 mL in 1 TUBE
source: ndc

Packages (3)

83608-102-02 1 TUBE in 1 CARTON (83608-102-02) / .5 mL in 1 TUBE 83608-102-05 1 TUBE in 1 CARTON (83608-102-05) / .5 mL in 1 TUBE 83608-102-15 1 TUBE in 1 CARTON (83608-102-15) / 1.5 mL in 1 TUBE

Ingredients (1)

benzocaine (5 g/100mL)

Linked Drug Pages (1)

STA-HARD ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "434a875b-2593-3b30-e063-6294a90a9518", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728"], "unii": ["U3RSY48JW5"], "spl_set_id": ["02ef794b-8e70-5c26-e063-6294a90a28d1"], "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": ["Novelties by Nasswalk, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (83608-102-02)  / .5 mL in 1 TUBE", "package_ndc": "83608-102-02", "marketing_start_date": "20230807"}, {"sample": false, "description": "1 TUBE in 1 CARTON (83608-102-05)  / .5 mL in 1 TUBE", "package_ndc": "83608-102-05", "marketing_start_date": "20230807"}, {"sample": false, "description": "1 TUBE in 1 CARTON (83608-102-15)  / 1.5 mL in 1 TUBE", "package_ndc": "83608-102-15", "marketing_start_date": "20230807"}], "brand_name": "STA-HARD", "product_id": "83608-102_434a875b-2593-3b30-e063-6294a90a9518", "dosage_form": "CREAM", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Increased Histamine Release [PE]", "Standardized Chemical Allergen [EPC]"], "product_ndc": "83608-102", "generic_name": "Desensitizing Lubricant", "labeler_name": "Novelties by Nasswalk, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "STA-HARD", "active_ingredients": [{"name": "BENZOCAINE", "strength": "5 g/100mL"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230807", "listing_expiration_date": "20261231"}