pranicura 5

Generic: glycerin, kaolin, calamine, menthol

Labeler: pranicura products llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name pranicura 5
Generic Name glycerin, kaolin, calamine, menthol
Labeler pranicura products llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

glycerin 25 g/100g, kaolin 12.5 g/100g, menthol 1 g/100g, zinc oxide 12.5 g/100g

Manufacturer
Pranicura Products LLC

Identifiers & Regulatory

Product NDC 71831-004
Product ID 71831-004_01fd300a-994a-4efa-9ec1-2ea6302bef7e
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M015
Listing Expiration 2026-12-31
Marketing Start 2021-10-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71831004
Hyphenated Format 71831-004

Supplemental Identifiers

UNII
PDC6A3C0OX 24H4NWX5CO L7T10EIP3A SOI2LOH54Z
NUI
N0000185370 N0000175629 N0000184306 N0000185001 M0000728 M0009417

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 pranicura 5 (source: ndc)
Generic Name glycerin, kaolin, calamine, menthol (source: ndc)
Application Number M015 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 25 g/100g
  • 12.5 g/100g
  • 1 g/100g
source: ndc
Packaging
  • 60 g in 1 JAR (71831-004-01)
source: ndc

Packages (1)

71831-004-01 60 g in 1 JAR (71831-004-01)

Ingredients (4)

glycerin (25 g/100g) kaolin (12.5 g/100g) menthol (1 g/100g) zinc oxide (12.5 g/100g)

Linked Drug Pages (1)

Pranicura 5 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "01fd300a-994a-4efa-9ec1-2ea6302bef7e", "openfda": {"nui": ["N0000185370", "N0000175629", "N0000184306", "N0000185001", "M0000728", "M0009417"], "unii": ["PDC6A3C0OX", "24H4NWX5CO", "L7T10EIP3A", "SOI2LOH54Z"], "spl_set_id": ["af520a58-3f3c-4d28-a41f-3ed8f74da095"], "pharm_class_cs": ["Allergens [CS]", "Glycerol [CS]"], "pharm_class_pe": ["Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]", "Increased IgG Production [PE]"], "pharm_class_epc": ["Non-Standardized Chemical Allergen [EPC]"], "manufacturer_name": ["Pranicura Products LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 g in 1 JAR (71831-004-01)", "package_ndc": "71831-004-01", "marketing_start_date": "20211018"}], "brand_name": "Pranicura 5", "product_id": "71831-004_01fd300a-994a-4efa-9ec1-2ea6302bef7e", "dosage_form": "CREAM", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]", "Glycerol [CS]", "Increased Histamine Release [PE]", "Increased IgG Production [PE]", "Non-Standardized Chemical Allergen [EPC]"], "product_ndc": "71831-004", "generic_name": "GLYCERIN, KAOLIN, CALAMINE, MENTHOL", "labeler_name": "Pranicura Products LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Pranicura 5", "active_ingredients": [{"name": "GLYCERIN", "strength": "25 g/100g"}, {"name": "KAOLIN", "strength": "12.5 g/100g"}, {"name": "MENTHOL", "strength": "1 g/100g"}, {"name": "ZINC OXIDE", "strength": "12.5 g/100g"}], "application_number": "M015", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20211018", "listing_expiration_date": "20261231"}