Anal Care GLO pack

Product NDC
84533-004
11-digit product format
845330004
Labeler code
84533
Product ID
84533-004_48651fac-0066-8236-e063-6294a90afa7b
Type
HUMAN OTC DRUG
Nonproprietary name
Carbon, Mirabilite, Peppermint oil, Borneol
Dosage form
CREAM
Route
RECTAL; TOPICAL
Labeler
WU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-11-08
Substance
ACTIVATED CHARCOAL; BORNEOL; GLYCERIN; HYALURONATE SODIUM; PANTHENOL; PEPPERMINT OIL; SODIUM SULFATE
Active strength
.37; 2; 6.33; .017; .067; .1; 1.33 g/100g; g/100g; 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
Anal Care GLO pack
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACTIVATED CHARCOAL.37 g/100g
BORNEOL2 g/100g
GLYCERIN6.33 g/100g
HYALURONATE SODIUM.017 g/100g
PANTHENOL.067 g/100g
PEPPERMINT OIL.1 g/100g
SODIUM SULFATE1.33 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2P3VWU3H10, M89NIB437X, PDC6A3C0OX, YSE9PPT4TH, WV9CM0O67Z, 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
84533-004-01Anal Care GLO pack3 g in 1 BOXCREAM32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84533-004ANAL CARE GLO PACK (CARBON, MIRABILITE, PEPPERMINT OIL, BORNEOL) CREAM [WU XI ZHONG ZHI WEI NA TECHNOLOGY CO., LTD.]1Current NDC, 1 package rows20241109_26612dae-21a0-6f12-e063-6394a90afe93.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84533-004-01845330004013 g in 1 BOX (84533-004-01) 3 g2024-11-08NoNoCurrent