Home NDC 80861-116 sulfur acne treatment
Product NDC 80861-116
11-digit product format 808610116
Labeler code 80861
Product ID 80861-116_57f4b9ac-1973-6868-e063-6394a90a9b21
Type HUMAN OTC DRUG
Nonproprietary name Sulfur
Dosage form CREAM
Route TOPICAL
Labeler Acne Free
Application M006
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-02-02
Substance SULFUR
Active strength .035 g/g
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 sulfur acne treatment
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SULFUR .035 g/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 70FD1KFU70 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1098781 Internal RxNorm 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 80861-116-01 sulfur acne treatment 1 g in 1 TUBE CREAM 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80861-116 SULFUR ACNE TREATMENT (SULFUR) CREAM [ACNE FREE] 2 Current NDC, 1 package rows 20240620_105545d8-974c-5a9a-e063-6294a90aecc4.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 42 of 55 · 1,088 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 80861-116-01 80861011601 1 g in 1 TUBE (80861-116-01) 1 g 2024-02-05 No No Current