Home NDC 83286-140 DRMTLGY Lip Silk - Bold
Product NDC 83286-140
11-digit product format 832860140
Labeler code 83286
Product ID 83286-140_52be8585-1e63-a82a-e063-6394a90a0065
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form LOTION
Route TOPICAL
Labeler DRMTLGY
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-10-30
Substance ZINC OXIDE
Active strength 132 mg/mL
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 DRMTLGY Lip Silk - Bold
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 132 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z 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 83286-140-01 DRMTLGY Lip Silk - Bold 3.5 mL in 1 BOTTLE, WITH APPLICATOR LOTION 3.5 1 83286-140-02 DRMTLGY Lip Silk - Bold 1 in 1 CARTON LOTION 1 1
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 26 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83286-140-01 83286014001 3.5 mL in 1 BOTTLE, WITH APPLICATOR 3.5 ml Historical 83286-140-02 83286014002 1 BOTTLE, WITH APPLICATOR in 1 CARTON (83286-140-02) / 3.5 mL in 1 BOTTLE, WITH APPLICATOR (83286-140-01) 2024-10-30 No No Current