Home NDC 54414-107-01 SPF 30 - Zinc Oxide Lip Balm
Product NDC 54414-107
Requested package NDC 54414-107-01
11-digit product format 544140107
Labeler code 54414
Product ID 54414-107_4607300e-c042-126c-e063-6394a90a76bc
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form STICK
Route TOPICAL
Labeler Dermatone
Application 352
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-04-29
Substance ZINC OXIDE
Active strength 150 mg/g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base SPF 30 - Zinc Oxide Lip Balm
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 150 mg/g
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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54414-107-01 SPF 30 - Zinc Oxide Lip Balm 4.2 g in 1 CONTAINER STICK 4.2 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 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 54414-107-01 54414010701 4.2 g in 1 CONTAINER (54414-107-01) 4.2 g 2025-04-29 No No Current