Home NDC 58503-168-01 SPOT ACNE TREATMENT 0.75OZ
Product NDC 58503-168
Requested package NDC 58503-168-01
11-digit product format 585030168
Labeler code 58503
Product ID 58503-168_06e07266-6482-e7ef-e063-6294a90a9395
Type HUMAN OTC DRUG
Nonproprietary name Benzoyl Peroxide
Dosage form GEL
Route TOPICAL
Labeler China Ningbo Shangge Cosmetics Technology Corp.
Application M006
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-10-04
Substance BENZOYL PEROXIDE
Active strength 2.5 g/100g
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 SPOT ACNE TREATMENT 0.75OZ
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOYL PEROXIDE 2.5 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination W9WZN9A0GM Internal UNII lookup
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 58503-168-01 SPOT ACNE TREATMENT 0.75OZ 1 in 1 BOX GEL 1 1 58503-168-01 SPOT ACNE TREATMENT 0.75OZ 21 g in 1 TUBE GEL 21 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58503-168 SPOT ACNE TREATMENT 0.75OZ (BENZOYL PEROXIDE) GEL [CHINA NINGBO SHANGGE COSMETICS TECHNOLOGY CORP.] 1 Current NDC, 2 package rows 20231005_06e07266-6483-e7ef-e063-6294a90a9395.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 41 of 54 · 1,079 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 58503-168-01 58503016801 1 TUBE in 1 BOX (58503-168-01) / 21 g in 1 TUBE 1 tube 2023-10-04 No No Current