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; GLYCERIN; LIDOCAINE
Active strength
.0012; .06; .04 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

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
GLYCERIN.06 g/g
LIDOCAINE.04 g/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7GXZ3858RY, PDC6A3C0OX, 98PI200987

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

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