Home NDC 55614-610 FARGELIN HEMORRHOIDAL
Product NDC 55614-610
11-digit product format 556140610
Labeler code 55614
Product ID 55614-610_43466548-41d6-9d96-e063-6294a90acd67
Type HUMAN OTC DRUG
Nonproprietary name Calamine, Petrolatum and Phenylephrine hydrochloride
Dosage form OINTMENT
Route RECTAL; TOPICAL
Labeler MADISON ONE ACME INC
Application M015
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-11-27
Substance ZINC OXIDE; FERRIC OXIDE RED; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE
Active strength 10.3; .05; 79.25; .25 g/100g; g/100g; g/100g; g/100g
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [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 FARGELIN HEMORRHOIDAL
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 10.3 g/100g FERRIC OXIDE RED .05 g/100g PETROLATUM 79.25 g/100g PHENYLEPHRINE HYDROCHLORIDE .25 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 55614-610-01 FARGELIN HEMORRHOIDAL 20 g in 1 TUBE, WITH APPLICATOR OINTMENT 20 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55614-610 FARGELIN HEMORRHOIDAL (CALAMINE, PETROLATUM AND PHENYLEPHRINE HYDROCHLORIDE) OINTMENT [MADISON ONE ACME INC] 5 Current NDC, Legacy NDC, 1 package rows 20241127_6844ad63-512d-496a-9458-011894185b0d.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 4 of 22 · 438 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HEMORRHOIDAL MINERAL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE CVS PHARMACY, INC 93482a9b-145b-42d4-96db-599c281a39f1 2026-06-10 Warnings Exact identifier application number: M015 Oudetas Lidocaine Cream LIDOCAINE CREAM Guangzhou Jingliang Cosmetics Co., Ltd. 53f11395-f460-943f-e063-6294a90affef 2026-06-10 Warnings Exact identifier application number: M015 Terramed Just Think Comfort Hemorrhoidal Wipes LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE Rida LLC f6ad00e7-c7b8-40b8-80c2-6e6bf85098b3 2026-06-08 Warnings Exact identifier application number: M015 Witch Hazel WITCH HAZEL CVS Pharmacy, Inc. 50f920da-b41a-480d-b3a0-df940caaee2d 2026-06-08 Warnings, Adverse reactions Exact identifier application number: M015 Adellina Lidocaine Numbing Cream Topical Anorectal Cream LIDOCAINE Guangdong Aimu Biological Technology Co., Ltd 5356cf53-935d-a02f-e063-6394a90a6e5a 2026-06-05 Warnings Exact identifier application number: M015 Hemorrhoidal GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM HyVee Inc b867f691-7a13-4659-b664-06aa36899310 2026-06-03 Warnings Exact identifier application number: M015 Healcome Lidocaine Numbing Cream LIDOCAINE YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD 9b4eac02-1b1f-4630-92b4-b1d8c21abab5 2026-05-29 Warnings Exact identifier application number: M015 Terramed Just Think Comfort Armor Antifungal Body Wash Lavender and chamomile TOLNAFTATE Rida LLC 5517c43f-03b2-499a-a217-d9cba3fb9fd2 2026-05-27 Warnings Exact identifier application number: M015 Terramed Just Think Comfort Armor Antifungal Body Wash Citrus TOLNAFTATE Rida LLC b4c5da66-5928-4352-ab90-fd46039e7955 2026-05-27 Warnings Exact identifier application number: M015 Terramed Just Think Comfort GynoCare BV Guard Intimate Wipes PRAMOXINE HYDROCHLORIDE Rida LLC bb29f156-37b8-400e-802b-3e2671cb7dc8 2026-05-27 Warnings Exact identifier application number: M015 myDerm MEDICAL NEW Soothing Hemorrhoidal WITCH HAZEL PENYLEPHRINE LIDOCAINE Inspec Solutions 2ff42501-7730-42de-99dd-6fc53bbdf25f 2026-05-27 Warnings Exact identifier application number: M015 Terramed Just Think Comfort Armor Antifungal Body Wash Icy Cool Menthol TOLNAFTATE Rida LLC 8b15cb3b-f7cb-4a80-94b2-eeeafc9794e8 2026-05-27 Warnings Exact identifier application number: M015 Lidocaine Roll-on LIDOCAINE YYBA Corp 52d060df-2095-dd68-e063-6394a90a7740 2026-05-27 Warnings Exact identifier application number: M015 PUVIDA NUMBING Cream Anorectal (Hemorrhoidal) Cream LIDOCAINE 5% NUMBING CREAM ANORECTAL (HEMORRHOIDAL) CREAM Jiangxi Yudexi Pharmaceutical Co., LTD 52a25b97-7721-6410-e063-6394a90a228f 2026-05-25 Warnings Exact identifier application number: M015 Arlun LIDOCAINE Cream LIDOCAINE CREAM Guangzhou Jingliang Cosmetics Co., Ltd. 5241c26b-6c91-65a5-e063-6394a90a2477 2026-05-20 Warnings Exact identifier application number: M015 tuiwaro LIDOCAINE Cream LIDOCAINE CREAM Guangzhou Jingliang Cosmetics Co., Ltd. 5223b7fe-6aba-c77b-e063-6394a90ad27b 2026-05-18 Warnings Exact identifier application number: M015 HEMORRHOIDAL WITH LIDOCAINE GLYCERIN, LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE, WHITE PETROLATUM CVS PHARMACY, INC 4d870c68-9e72-464e-b0b8-900d0d661e43 2026-05-14 Warnings Exact identifier application number: M015 Oxify LIDOCAINE 5% Weeks & Leo Compnay, INC. 51cd58f7-c1c9-f4e2-e063-6294a90ad970 2026-05-14 Warnings Exact identifier application number: M015 Lidocaine anorectal cream LIDOCAINE 5% EveryMarket Inc 1604daec-812f-4684-ba98-fbcda07a7461 2026-05-12 Warnings Exact identifier application number: M015 PREPARATION H SOOTHING RELIEF CLEANSING AND COOLING WIPES WITCH HAZEL Haleon US Holdings LLC 485437a8-b2e9-4acf-a20e-edb1f08a9cae 2026-05-11 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 55614-610-01 55614061001 20 g in 1 TUBE, WITH APPLICATOR (55614-610-01) 20 g 2019-11-27 0000-00-00 No No Current