Home NDC 84558-009-01 SUKKHI Polyamino Sugar Condensate Massage Cream
Product NDC 84558-009
Requested package NDC 84558-009-01
11-digit product format 845580009
Labeler code 84558
Product ID 84558-009_34aaa90f-882f-d5e5-e063-6394a90ad2f8
Type HUMAN OTC DRUG
Nonproprietary name SUKKHI Polyamino Sugar Condensate Massage Cream
Dosage form CREAM
Route CUTANEOUS
Labeler GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-05-07
Substance GLYCERIN; DIMETHICONE
Active strength 4; 2 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], Skin Barrier Activity [PE]
NDC exclude flag No
Listing certified through 2026-12-31
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 SUKKHI Polyamino Sugar Condensate Massage Cream
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GLYCERIN 4 g/100mL DIMETHICONE 2 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination PDC6A3C0OX Internal UNII lookup 92RU3N3Y1O Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84558-009-01 SUKKHI Polyamino Sugar Condensate Massage Cream 100 mL in 1 BOTTLE CREAM 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84558-009 SUKKHI POLYAMINO SUGAR CONDENSATE MASSAGE CREAM CREAM [GUANGZHOU YUSONG FINE CHEMICLS CO., LTD] 2 Current NDC, 1 package rows 20250510_34aaf4ef-26dc-f87e-e063-6394a90a9a59.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 84558-009-01 84558000901 100 mL in 1 BOTTLE (84558-009-01) 100 ml 2025-05-07 No No Current