Home NDC 87512-004 SmileCare Mouth Ulcer Gel
Product NDC 87512-004
11-digit product format 875120004
Labeler code 87512
Product ID 87512-004_4d6db039-5b98-8f3f-e063-6294a90a9d85
Type HUMAN OTC DRUG
Nonproprietary name Menthol
Dosage form GEL
Route ORAL
Labeler Yantai Aien Biotechnology Co., Ltd.
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-03-20
Substance MENTHOL
Active strength .1 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 SmileCare Mouth Ulcer Gel
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL .1 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A 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 87512-004-01 SmileCare Mouth Ulcer Gel 10 g in 1 TUBE GEL 10 1 87512-004-02 SmileCare Mouth Ulcer Gel 15 g in 1 TUBE GEL 15 1 87512-004-03 SmileCare Mouth Ulcer Gel 20 g in 1 TUBE GEL 20 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 29 of 40 · 786 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 87512-004-01 87512000401 10 g in 1 TUBE (87512-004-01) 10 g 2026-03-20 No No Current 87512-004-02 87512000402 15 g in 1 TUBE (87512-004-02) 15 g 2026-03-20 No No Current 87512-004-03 87512000403 20 g in 1 TUBE (87512-004-03) 20 g 2026-03-20 No No Current