FDA.reportPublic FDA data

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
IngredientStrength
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
IdentifierFDA.report destination
7GXZ3858RYInternal UNII lookup
98PI200987Internal UNII lookup
PDC6A3C0OXInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
48697377-61c0-1b0a-e063-6294a90a3293Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85524-2602-1Hemorrhoid and Fissure42.5 g in 1 BOTTLEOINTMENT42.51
85524-2602-2Hemorrhoid and Fissure1 in 1 BOXOINTMENT11
85524-2602-3Hemorrhoid and Fissure42.5 g in 1 BOTTLEOINTMENT42.51
85524-2602-4Hemorrhoid and Fissure1 in 1 BOXOINTMENT11
85524-2602-5Hemorrhoid and Fissure42.5 g in 1 BOTTLEOINTMENT42.51
85524-2602-6Hemorrhoid and Fissure1 in 1 BOXOINTMENT11

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 21 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mayinglong HemorrhoidalPETROLATUM, ZINC OXIDEMayinglong Pharmaceutical Group Co., Ltd.b14192ea-1bf7-da6a-e053-2a95a90a5b5e2023-12-08WarningsExact identifier
application number: M015
Hemorrhoidal cooling gelPHENYLEPHRINE HCL, WITCH HAZELWALGREENS03bbe258-e00d-13cc-e063-6394a90ae3452023-12-05WarningsExact identifier
application number: M015
Hemorrhoidal Pain ReliefMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLWALGREENS03bc5c1a-d493-5082-e063-6394a90ae87b2023-12-05WarningsExact identifier
application number: M015
Bloop Hemorrhoid Relief TopicalGLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCLThree Nations Corp0b6419e3-f1c7-bdfe-e063-6294a90a5d922023-11-30WarningsExact identifier
application number: M015
Bloop Fissure Healing Anorectal TopicalLIDOCAINEThree Nations Corp0b645092-ebc4-e4bb-e063-6294a90ad4cf2023-11-30WarningsExact identifier
application number: M015
SIMPLY VITAL HEMORRHOID and ANORECTAL RELIEFLIDOCAINEALPHA PLANTS INC79fa4b89-382f-45fa-a792-90a9fe5bf5732023-11-11WarningsExact identifier
application number: M015
BODY ACTION PRODUCTS Prolong LubricatingBENZOCAINEPRODUCT MAX GROUP INC3bef5915-1c98-4011-baa9-ad0bbef200c22023-11-10WarningsExact identifier
application number: M015
BODY ACTION PRODUCTS Butt Eze BenzocaineBENZOCAINEPRODUCT MAX GROUP INCba75b129-7939-4373-91f5-1772976e6d612023-11-10WarningsExact identifier
application number: M015
Uber Numb Topical AnestheticLIDOCAINE HYDROCHLORIDEUberScientific, LLC441c802f-a363-1530-e054-00144ff88e882023-11-10WarningsExact identifier
application number: M015
Uber Numb Topical AnestheticLIDOCAINE HYDROCHLORIDEUberScientific, LLC4939a547-c94b-3350-e054-00144ff88e882023-11-10WarningsExact identifier
application number: M015
DR REAL NUMB Topical AnorectalLIDOCAINEFUZZYLULU LLC378d8edc-2120-416d-854c-8881c2950efe2023-11-09WarningsExact identifier
application number: M015
The Pharma C Company Medicated Foam with Witch HazelWITCH HAZELKleen Test Products Corporation1a1fbe83-be45-4654-a7bb-e934e1ccd0c62023-11-09WarningsExact identifier
application number: M015
The Pharma-C Company Medicated Hemorrhoidal PadsWITCH HAZELKleen Test Products Corporation357703ab-4e7a-41f6-9ecf-aa98acc2d92e2023-11-09WarningsExact identifier
application number: M015
DOCTORS TOUCH Erase The Pain LidocaineLIDOCAINE HYDROCHLORIDEDOCTOR'S CHOICE MEDICAL, LLC3dc9947b-8196-4a38-97b4-c2340ee77e0f2023-11-06WarningsExact identifier
application number: M015
SCALAR Pain Relief CreamMENTHOLMiracle Balance, LLC52a13cfe-3f46-45f8-a5af-ce07ea5758e32023-11-06WarningsExact identifier
application number: M015
SIMPLE PROMISE Simple H Hemorrhoid Relief CreamPHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDESIMPLE PROMISE PTE LTDf6622caa-3b31-9b07-e053-2a95a90a8a512023-11-06WarningsExact identifier
application number: M015
WAXUP NumbingLIDOCAINE HYDROCHLORIDECONSTRUSOLUTION, LLC4f1645ab-1b19-4d69-99c3-9ea275b01a872023-11-06WarningsExact identifier
application number: M015
SECONDARY NUMB Lidocaine Phenylephrine GelLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDELALANI Rx Consulting, Inc.0f13f7b5-e3b1-451e-a6d6-e7e15bd044432023-11-06WarningsExact identifier
application number: M015
Brazzers Anal DesensitizingLIDOCAINEMetro Media Entceacd80c-0dd6-4e21-97da-56da877b1c902023-11-06WarningsExact identifier
application number: M015
NUMB PLUS Maximum Strength AnorectalLIDOCAINESEENEXT VENTURE LTDa7c37b2a-b647-43d7-b43b-87bbece354302023-11-05WarningsExact identifier
application number: M015

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85524-2602-18552426020142.5 g in 1 BOTTLE42.5 gHistorical
85524-2602-2855242602021 BOTTLE in 1 BOX (85524-2602-2) / 42.5 g in 1 BOTTLE (85524-2602-1) 1 bottle2026-01-19NoNoCurrent
85524-2602-38552426020342.5 g in 1 BOTTLE42.5 gHistorical
85524-2602-4855242602041 BOTTLE in 1 BOX (85524-2602-4) / 42.5 g in 1 BOTTLE (85524-2602-3) 1 bottle2026-01-19YesNoCurrent
85524-2602-58552426020542.5 g in 1 BOTTLE42.5 gHistorical
85524-2602-6855242602061 BOTTLE in 1 BOX (85524-2602-6) / 42.5 g in 1 BOTTLE (85524-2602-5) 1 bottle2026-01-19YesNoCurrent