Home NDC 11527-065 Sheffield Zinc Oxide
Product NDC 11527-065
11-digit product format 115270065
Labeler code 11527
Product ID 11527-065_9dac2c01-6044-4c48-9d36-8e3e0bd764de
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form OINTMENT
Route TOPICAL
Labeler Sheffield Pharmaceuticals LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2005-01-11
Substance ZINC OXIDE
Active strength 200 mg/g
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 Sheffield Zinc Oxide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 200 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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198911 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 11527-065-34 Sheffield Zinc Oxide 1 in 1 CARTON OINTMENT 1 2 11527-065-34 Sheffield Zinc Oxide 28 g in 1 TUBE OINTMENT 28 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11527-065 SHEFFIELD ZINC OXIDE (ZINC OXIDE) OINTMENT [SHEFFIELD PHARMACEUTICALS LLC] 2 Current NDC, Legacy NDC, 2 package rows 20231129_60b54c04-4387-4954-951d-165809947310.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 55 of 68 · 1,357 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 11527-065-34 11527006534 1 TUBE in 1 CARTON (11527-065-34) / 28 g in 1 TUBE 1 tube 2005-01-11 0000-00-00 No No Current