Home NDC 71831-004 Pranicura 5
Product NDC 71831-004
11-digit product format 718310004
Labeler code 71831
Product ID 71831-004_01fd300a-994a-4efa-9ec1-2ea6302bef7e
Type HUMAN OTC DRUG
Nonproprietary name GLYCERIN, KAOLIN, CALAMINE, MENTHOL
Dosage form CREAM
Route TOPICAL
Labeler Pranicura Products LLC
Application M015
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-10-18
Substance GLYCERIN; KAOLIN; ZINC OXIDE; MENTHOL
Active strength 25; 12.5; 12.5; 1 g/100g; g/100g; g/100g; g/100g
Pharmacologic classes 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]
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 Pranicura 5
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GLYCERIN 25 g/100g KAOLIN 12.5 g/100g ZINC OXIDE 12.5 g/100g MENTHOL 1 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71831-004-01 Pranicura 5 60 g in 1 JAR CREAM 60 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71831-004 PRANICURA 5 (GLYCERIN, KAOLIN, CALAMINE, MENTHOL) CREAM [PRANICURA GROUP LLC] 4 Current NDC, Legacy NDC, 1 package rows 20241202_af520a58-3f3c-4d28-a41f-3ed8f74da095.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 15 of 22 · 438 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join BODY ACTION PRODUCTS Anal Glide Extra BENZOCAINE PRODUCT MAX GROUP INC 282ac8d3-2caf-42de-b347-450e9c7a9e50 2025-04-03 Warnings Exact identifier application number: M015 Numb 520 LIDOCAINE Clinical Resolution Laboratory, Inc. 984c4bee-0d44-4e0f-a057-0d54400c4cac 2025-04-02 Warnings Exact identifier application number: M015 hemorrhoidal MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL Bionpharma Inc. 1790da99-2a22-e2a2-e063-6394a90ac36f 2025-03-31 Warnings Exact identifier application number: M015 HemAway LIDOCAINE Melaleuca, Inc. cf842adf-fcd7-2c8c-e053-2995a90adea6 2025-03-27 Warnings Exact identifier application number: M015 Numb and Number Anorectal Cream LIDOCAINE Dermtech Labs, Inc 31420635-5021-173d-e063-6294a90a407a 2025-03-26 Warnings Exact identifier application number: M015 Leader Maximum Strength Hemorrhoidal Relief LIDOCAINE Cardinal Health,Inc. 65c780b0-7f47-4ae9-a847-c22deaaa2888 2025-03-21 Warnings Exact identifier application number: M015 Curist Hemorrhoid Fissure Relief LIDOCAINE Little Pharma, Inc 2fb02b00-acdb-5184-e063-6294a90ae1c8 2025-03-06 Warnings Exact identifier application number: M015 Thera Plus Hemorrhoidal GLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE FOURSTAR GROUP USA, INC. 87143a7a-7b2d-4b67-afda-2355697e7300 2025-03-04 Warnings Exact identifier application number: M015 Numbskin Maximum Strength Pain Reliever LIDOCAINE Shinpharma Inc 2f288bde-99fd-42f8-e063-6394a90a0f05 2025-02-27 Warnings Exact identifier application number: M015 PREPARATION H TOTABLES IRRITATION RELIEF WIPES WITCH HAZEL Haleon US Holdings LLC 1953ec64-20ce-488b-8f14-44e15cc9e720 2025-02-21 Warnings Exact identifier application number: M015 LBRI STOP THE PAIN Super Aloe Pain Relief Cream MENTHOL, METHYL SALICYLATE L'BRI HEALTH AND BEAUTY INC 62e18a37-c0db-4b1e-a6a1-35684cc00e08 2025-01-28 Warnings Exact identifier application number: M015 Hemorrhoidal PAIN RELIEF NeilMed Pharmaceuticals Inc. 038a2cf5-1b72-227b-e063-6394a90a84ad 2025-01-24 Warnings Exact identifier application number: M015 lidocaine LIDOCAINE Nivagen Pharmaceuticals, Inc. 32964ec3-1880-477b-9f71-2222c39106aa 2025-01-23 Warnings Exact identifier application number: M015 Hemorrhoidal cocoa butter HEMORRHOIDAL NeilMed Pharmaceuticals Inc. 03b159b0-b960-b38d-e063-6394a90a9462 2025-01-17 Warnings Exact identifier application number: M015 Gentle Laxative Bisacodyl GENTLE LAXATIVE BISACODYL NeilMed Pharmaceuticals Inc 03b3733a-4d78-149f-e063-6294a90a6518 2025-01-17 Warnings Exact identifier application number: M015 Glycerin Laxative GLYCERIN BASED GENTLE AND EFFECTIVE LAXATIVE ADULT CONSTIPATION RELIEF NeilMed Pharmaceuticals Inc. 03b4be69-6488-76be-e063-6394a90a7edf 2025-01-17 Warnings Exact identifier application number: M015 Pre-moistened Medicated Wipes, Pre-moistened Medicated Wipes Witch Hazel 50%/Hemorrhoidal Astringent, Walgreens Pre-moistened Medicated Wipes, Walgreens Pre-moistened Medicated Wipes Witch Hazel 50%/Hemorrhoidal Astringent WITCH HAZEL Walgreens Company 209a111b-d169-cb5d-e063-6394a90a33ca 2025-01-15 Warnings Exact identifier application number: M015 Pre-moistened Medicated Pads, Pre-moistened Medicated Pads Hemorrhoidal Pads with Witch Hazel, Walgreens Pre-moistened Medicated Pads, Walgreens Pre-moistened Medicated Pads Hemorrhoidal Pads with Witch Hazel WITCH HAZEL Walgreens Company 1e2dcec1-a1fe-71d2-e063-6394a90a9908 2025-01-15 Warnings Exact identifier application number: M015 AER Pre-moistened Witch Hazel Pad WITCH HAZEL Birchwood Laboratories LLC 1cca622f-0a6b-4f35-9355-34c249ee705e 2025-01-14 Warnings Exact identifier application number: M015 B-SURE Traveler Towelette B-SURE TRAVELER Birchwood Laboratories LLC e1a5da94-6a1a-497b-a737-1c1541bf0404 2025-01-14 Warnings Exact identifier application number: M015
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71831-004-01 71831000401 60 g in 1 JAR (71831-004-01) 60 g 2021-10-18 0000-00-00 No No Current