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 2 of 22 · 438 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Numb520Spray LIDOCAINE, PHENYLEPHRINE HCL Ebanel Laboratories, Inc. 350f0e25-fbdc-c0c0-e063-6294a90a50a0 2026-08-20 Warnings Exact identifier application number: M015 Gembooxt Topical Numbing Cream LIDOCAINE Guangdong Quadrant Ecological Technology Co., Ltd. 49951a3e-3b62-3d66-e063-6294a90a9360 2026-08-12 Warnings Exact identifier application number: M015 NumbMD Lidocaine Cream Anorectal(hemorrhoidal) LIDOCAINE 5% EveryMarket Inc 52379055-d017-4d98-e063-6294a90a196c 2026-08-12 Warnings Exact identifier application number: M015 Nupharmisto NumbMD Lidocaine Cream LIDOCAINE 5% EveryMarket Inc 52369a41-820d-cd7a-e063-6394a90ac6d1 2026-08-12 Warnings Exact identifier application number: M015 Nupharmisto NumbMD Lidocaine Cream LIDOCAINE 5% EveryMarket Inc 51d370b4-1c34-d203-e063-6394a90a80b1 2026-08-12 Warnings Exact identifier application number: M015 Nupharmisto NumbMD 5% Lidocaine cream LIDOCAINE 5% EveryMarket Inc 507d0c2c-9517-40f8-e063-6394a90a1996 2026-08-12 Warnings Exact identifier application number: M015 Nupharmisto NumbMD LIDOCAINE cream anorectal (hemorrhoidal) LIDOCAINE CREAM ANORECTAL EveryMarket Inc 483d81a3-7493-3391-e063-6394a90a2e3d 2026-08-12 Warnings Exact identifier application number: M015 Numbing Cream LIDOCAINE 100 KARMA INC 35b5ba9d-da1d-55d6-e063-6294a90a5fa8 2026-08-12 Warnings Exact identifier application number: M015 Treatonic hemorrhoid treatment 5% LIDOCAINE 100 KARMA INC 41442fa7-c511-07ca-e063-6294a90a3992 2026-08-12 Warnings Exact identifier application number: M015 Lidocaine numbing cream 5% LIDOCAINE 100 KARMA INC 47380721-6633-4a50-e063-6394a90aca94 2026-08-12 Warnings Exact identifier application number: M015 Treatonic 5% Lidocaine Cream 5% LIDOCAINE CREAM 100 KARMA INC 47dc7630-9a74-1989-e063-6294a90a50bb 2026-08-12 Warnings Exact identifier application number: M015 Treatonic 5% Lidocaine Cream 5% LIDOCAINE CREAM 100 KARMA INC 49e6b69f-bd6e-b415-e063-6394a90a8e65 2026-08-12 Warnings Exact identifier application number: M015 Gniby LIDOCAINE ANORECTAL HEMORRHOIDAL Numbing LIDOCAINE Putian Licheng District Zhijiancheng Trading Co., Ltd. 4a7be9eb-5e57-90e8-e063-6394a90aad9e 2026-08-08 Warnings Exact identifier application number: M015 THE SOLU TION LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE HYDROCHLORIDE SCALP TECH INC 58793581-8826-9a74-e063-6294a90a2465 2026-08-06 Warnings Exact identifier application number: M015 Lidocaine Numbing Cream LIDOCAINE Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. 5457b3d7-e6b6-34a7-e063-6394a90aa240 2026-08-03 Warnings Exact identifier application number: M015 HEMORRHOIDALCREAMPROCURE PHENYLEPHRINE HCL, PETROLATUM, MINERAL OIL TWIN MED, LLC e9c44756-1c98-41be-e053-2995a90a35b4 2026-08-03 Warnings Exact identifier application number: M015 Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE YYBA CORP 582a0001-da1e-909a-e063-6394a90a2b11 2026-08-03 Warnings Exact identifier application number: M015 up and up PHENYLEPHRINE HYDROCHLORIDE Target Corporation b42775ae-44fe-487e-b9ca-21d9687020a9 2026-07-29 Warnings Exact identifier application number: M015 Acolye Numbing Cream Anorectal(Hemorrhoidal) Cream LIDOCAINE Guangdong Aimu Biological Technology Co., Ltd 578fa642-ff30-e511-e063-6294a90a5987 2026-07-26 Warnings Exact identifier application number: M015 CVS Topical Anesthetic Hemorrhoidal DIBUCAINE CVS PHARMACY, INC 9f3d4fdb-ad82-4ab8-8a9e-252d027068ab 2026-07-25 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