AN12 ANUS PREMIUM CLEANSER

Product NDC
82385-102
11-digit product format
823850102
Labeler code
82385
Product ID
82385-102_2cfb5387-0aa8-4e1b-e063-6394a90a85ee
Type
HUMAN OTC DRUG
Nonproprietary name
Glycerin, Allantoin
Dosage form
GEL
Route
TOPICAL
Labeler
BESTVALUE Co., Ltd
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2021-11-19
Substance
ALLANTOIN; GLYCERIN
Active strength
.1; 3 g/100mL; g/100mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AN12 ANUS PREMIUM CLEANSER
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALLANTOIN.1 g/100mL
GLYCERIN3 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii344S277G0Z, PDC6A3C0OX

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82385-102-01AN12 ANUS PREMIUM CLEANSER50 mL in 1 BOTTLE, PUMPGEL505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82385-102AN12 ANUS PREMIUM CLEANSER (GLYCERIN, ALLANTOIN) GEL [BESTVALUE CO., LTD]5Current NDC, Legacy NDC, 1 package rows20250201_d11b7443-2dfc-3e17-e053-2a95a90afb76.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82385-102-018238501020150 mL in 1 BOTTLE, PUMP (82385-102-01) 50 ml2021-11-190000-00-00NoNoCurrent