Home NDC 84533-004 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 SODIUM SULFATE; HYALURONATE SODIUM; PANTHENOL; ACTIVATED CHARCOAL; PEPPERMINT OIL; BORNEOL; GLYCERIN
Active strength 1.33; .017; .067; .37; .1; 2; 6.33 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 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 Anal Care GLO pack
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM SULFATE 1.33 g/100g HYALURONATE SODIUM .017 g/100g PANTHENOL .067 g/100g ACTIVATED CHARCOAL .37 g/100g PEPPERMINT OIL .1 g/100g BORNEOL 2 g/100g GLYCERIN 6.33 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 7 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84533-004-01 Anal Care GLO pack 3 g in 1 BOX CREAM 3 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84533-004 ANAL CARE GLO PACK (CARBON, MIRABILITE, PEPPERMINT OIL, BORNEOL) CREAM [WU XI ZHONG ZHI WEI NA TECHNOLOGY CO., LTD.] 1 Current NDC, 1 package rows 20241109_26612dae-21a0-6f12-e063-6394a90afe93.zip
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 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84533-004-01 84533000401 3 g in 1 BOX (84533-004-01) 3 g 2024-11-08 No No Current