FDA.reportPublic FDA data

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
FERRIC OXIDE RED; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; ZINC OXIDE
Active strength
.05; 79.25; .25; 10.3 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

Additional Listing Data#

Finished product
Yes
Brand name base
FARGELIN HEMORRHOIDAL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE.05 g/100g
FERRIC OXIDE RED79.25 g/100g
PETROLATUM.25 g/100g
PHENYLEPHRINE HYDROCHLORIDE10.3 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
1K09F3G675Internal UNII lookup
4T6H12BN9UInternal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6844ad63-512d-496a-9458-011894185b0dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55614-610-01FARGELIN HEMORRHOIDAL20 g in 1 TUBE, WITH APPLICATOROINTMENT206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55614-610FARGELIN HEMORRHOIDAL (CALAMINE, PETROLATUM AND PHENYLEPHRINE HYDROCHLORIDE) OINTMENT [MADISON ONE ACME INC]5Current NDC, Legacy NDC, 1 package rows20241127_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 1 of 22 · 422 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acolye Numbing Cream Anorectal(Hemorrhoidal) CreamLIDOCAINEGuangdong Aimu Biological Technology Co., Ltd578fa642-ff30-e511-e063-6294a90a59872026-07-26WarningsExact identifier
application number: M015
CVS Topical Anesthetic HemorrhoidalDIBUCAINECVS PHARMACY, INC9f3d4fdb-ad82-4ab8-8a9e-252d027068ab2026-07-25WarningsExact identifier
application number: M015
Moisture BarrierMENTHOL 0.44%, ZINC OXIDE 20.6%Walgreen Company258f3392-0f42-21e8-e063-6294a90ae9ad2026-07-22WarningsExact identifier
application number: M015
RectaEase Hemorrhoid Relief CreamLIDOCAINETrifecta Pharmaceuticals USA LLCc054921a-9f1b-7c75-e053-2995a90a17382026-07-20WarningsExact identifier
application number: M015
Lidocaine Numbing CreamLIDOCAINEKORVIA GLOBAL Inc.5690db03-4d62-9660-e063-6394a90a2fc02026-07-14WarningsExact identifier
application number: M015
Gembooxt Topical Numbing CreamLIDOCAINE HCLGuangdong Quadrant Ecological Technology Co., Ltd.49951a3e-3b62-3d66-e063-6294a90a93602026-07-13WarningsExact identifier
application number: M015
Zmztuhua Numbing CreamLIDOCAINEGuangzhou Hechuang Commercial Service Co.,Ltd.56417dc6-c14b-ad17-e063-6294a90af7e52026-07-10WarningsExact identifier
application number: M015
Tina Davies IceCreamLIDOCAINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDETINA DAVIES PROFESSIONAL LLC6a2b3199-f405-4455-9a02-8885d24eef9c2026-07-09WarningsExact identifier
application number: M015
Drs pharmacy HEMORRHOIDALPHENYLEPHRINE HCL, WITCH HAZELOL PHARMA TECH, LLC Drs PHARMACY164169b9-0627-9d1a-e063-6294a90ac46d2026-07-09WarningsExact identifier
application number: M015
Witch HazelWITCH HAZELH E B09b814f4-86b5-4810-bf52-cc88396451c22026-07-07Warnings, Adverse reactionsExact identifier
application number: M015
Witch HazelWITCH HAZELADUSA Distribution, LLCc50d0496-6f09-43c2-9383-3250885968c92026-06-29Warnings, Adverse reactionsExact identifier
application number: M015
Adellina Lidocaine Numbing Cream Topical Anorectal CreamLIDOCAINEGuangdong Aimu Biological Technology Co., Ltd55260a3e-637a-c53b-e063-6394a90a1b092026-06-27WarningsExact identifier
application number: M015
Walgreens HemorrhoidalHEMORRHOIDAL RECTAL SUPPOSITORIESWalgreens20c41406-99b2-bc89-e063-6294a90aed732026-06-25WarningsExact identifier
application number: M015
CalaSootheCALAMINE, MENTHOL, AND ZINC OXIDEDynarex Corporation54f12005-acfe-4821-e063-6394a90ac3042026-06-24WarningsExact identifier
application number: M015
tina davies IceCream HemorrhoidalLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDETINA DAVIES PROFESSIONAL LLC10d2c3e4-cf4d-42ce-8fc3-33b97f63cccd2026-06-24WarningsExact identifier
application number: M015
Haemorrhoidal Pain ReliefANORECTAL CREAMNeilMed Pharmaceuticals Inc544a9d6f-4eaa-613e-e063-6294a90a0c502026-06-15WarningsExact identifier
application number: M015
Lidocaine Numbing CreamLIDOCAINEGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.5457b3d7-e6b6-34a7-e063-6394a90aa2402026-06-15WarningsExact identifier
application number: M015
Dr.Seymour Butts HemorrhoidLIDOCAINE5% PHENYLEPHRINE HCL 0.25% HEMORRHOIDJiangxi Yudexi Pharmaceutical Co., LTD4981c7d9-53ee-2a7b-e063-6394a90add012026-06-12WarningsExact identifier
application number: M015
ANIXIKE NumbingLIDOCAINE4% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4d5b7c4c-feac-4eeb-e063-6294a90a57482026-06-11WarningsExact identifier
application number: M015
tina davies IceJelly HemorrhoidalLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDETINA DAVIES PROFESSIONAL LLC580559bf-d91f-4bb3-9c9b-b7e2cd0686fd2026-06-11WarningsExact identifier
application number: M015

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55614-610-015561406100120 g in 1 TUBE, WITH APPLICATOR (55614-610-01) 20 g2019-11-270000-00-00NoNoCurrent