Home NDC 61354-115 Cream
Product NDC 61354-115
11-digit product format 613540115
Labeler code 61354
Product ID 61354-115_08a1e862-b55b-fb84-e063-6294a90a016a
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Oxygen Development LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-10-26
Substance ZINC OXIDE
Active strength 21.76 mg/100mg
NDC exclude flag No
Listing certified through 2026-12-31
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 Cream
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 21.76 mg/100mg
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 61354-115-01 Cream 100 mg in 1 TUBE CREAM 100 1 61354-115-02 Cream 1 in 1 CARTON CREAM 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61354-115 CREAM (ZINC OXIDE) CREAM [OXYGEN DEVELOPMENT LLC] 1 Current NDC, 2 package rows 20231030_08a1e862-b55a-fb84-e063-6294a90a016a.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 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 61354-115-01 61354011501 100 mg in 1 TUBE 100 mg Historical 61354-115-02 61354011502 1 TUBE in 1 CARTON (61354-115-02) / 100 mg in 1 TUBE (61354-115-01) 1 tube 2023-10-26 No No Current