Hemorrhoid, Fissure, Proctalgia Ointments

Product NDC
84533-003
11-digit product format
845330003
Labeler code
84533
Product ID
84533-003_48652f88-8d2e-2b65-e063-6394a90afb34
Type
HUMAN OTC DRUG
Nonproprietary name
Carbon, Mirabilite, Peppermint oil, Borneol, Glycerin
Dosage form
SALVE
Route
TOPICAL
Labeler
WU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd.
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-08-06
Substance
ACTIVATED CHARCOAL; BORNEOL; GLYCERIN; PEPPERMINT OIL; SODIUM SULFATE
Active strength
1; 3; 8; .2; 2 g/100g; g/100g; g/100g; g/100g; g/100g
Pharmacologic classes
Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Glycerol [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hemorrhoid, Fissure, Proctalgia Ointments
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACTIVATED CHARCOAL1 g/100g
BORNEOL3 g/100g
GLYCERIN8 g/100g
PEPPERMINT OIL.2 g/100g
SODIUM SULFATE2 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2P3VWU3H10, M89NIB437X, PDC6A3C0OX, AV092KU4JH, 0YPR65R21J

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84533-003-01Hemorrhoid, Fissure, Proctalgia Ointments7 g in 1 BOXSALVE74

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84533-003HEMORRHOID, FISSURE, PROCTALGIA OINTMENTS (CARBON, MIRABILITE, PEPPERMINT OIL, BORNEOL, GLYCERIN) SALVE [WU XI ZHONG ZHI WEI NA TECHNOLOGY CO., LTD.]3Current NDC, 1 package rows20240820_1efe43d5-a29b-5cb2-e063-6394a90aca66.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84533-003-01845330003017 g in 1 BOX (84533-003-01) 7 g2024-08-06NoNoCurrent