Home NDC 85524-2602 Hemorrhoid and Fissure
Product NDC 85524-2602
11-digit product format 855242602
Labeler code 85524
Product ID 85524-2602_48697377-61c1-1b0a-e063-6294a90a3293
Type HUMAN OTC DRUG
Nonproprietary name Glycerin 6%,Lidocaine 4%,Ectoin 0.12%
Dosage form OINTMENT
Route TOPICAL
Labeler FlexiGo Inc
Application M015
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-01-19
Substance ECTOIN; LIDOCAINE; GLYCERIN
Active strength .0012; .04; .06 g/g; g/g; g/g
Pharmacologic classes Allergens [CS], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Local Anesthesia [PE], Non-Standardized Chemical Allergen [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 Hemorrhoid and Fissure
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ECTOIN .0012 g/g LIDOCAINE .04 g/g GLYCERIN .06 g/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7GXZ3858RY Internal UNII lookup 98PI200987 Internal UNII lookup PDC6A3C0OX Internal UNII lookup
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 85524-2602-1 Hemorrhoid and Fissure 42.5 g in 1 BOTTLE OINTMENT 42.5 1 85524-2602-2 Hemorrhoid and Fissure 1 in 1 BOX OINTMENT 1 1 85524-2602-3 Hemorrhoid and Fissure 42.5 g in 1 BOTTLE OINTMENT 42.5 1 85524-2602-4 Hemorrhoid and Fissure 1 in 1 BOX OINTMENT 1 1 85524-2602-5 Hemorrhoid and Fissure 42.5 g in 1 BOTTLE OINTMENT 42.5 1 85524-2602-6 Hemorrhoid and Fissure 1 in 1 BOX OINTMENT 1 1
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 Sample Exclude flag Status 85524-2602-1 85524260201 42.5 g in 1 BOTTLE 42.5 g Historical 85524-2602-2 85524260202 1 BOTTLE in 1 BOX (85524-2602-2) / 42.5 g in 1 BOTTLE (85524-2602-1) 1 bottle 2026-01-19 No No Current 85524-2602-3 85524260203 42.5 g in 1 BOTTLE 42.5 g Historical 85524-2602-4 85524260204 1 BOTTLE in 1 BOX (85524-2602-4) / 42.5 g in 1 BOTTLE (85524-2602-3) 1 bottle 2026-01-19 Yes No Current 85524-2602-5 85524260205 42.5 g in 1 BOTTLE 42.5 g Historical 85524-2602-6 85524260206 1 BOTTLE in 1 BOX (85524-2602-6) / 42.5 g in 1 BOTTLE (85524-2602-5) 1 bottle 2026-01-19 Yes No Current