Home NDC 65517-2023 DUKAL WHITE PETROLATUM
Product NDC 65517-2023
11-digit product format 655172023
Labeler code 65517
Product ID 65517-2023_26bc7f03-950e-5fc7-e063-6394a90a3e4d
Type HUMAN OTC DRUG
Nonproprietary name PETROLATUM
Dosage form JELLY
Route TOPICAL
Labeler Dukal LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-12-13
Substance PETROLATUM
Active strength 1 g/g
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 DUKAL WHITE PETROLATUM
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PETROLATUM 1 g/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4T6H12BN9U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 204754 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 65517-2023-1 DUKAL WHITE PETROLATUM 6 in 1 CASE JELLY 6 5 65517-2023-1 DUKAL WHITE PETROLATUM 144 in 1 BOX JELLY 144 5 65517-2023-2 DUKAL WHITE PETROLATUM 144 in 1 CASE JELLY 144 5 65517-2023-2 DUKAL WHITE PETROLATUM 28 g in 1 TUBE JELLY 28 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65517-2023 DUKAL WHITE PETROLATUM (PETROLATUM) JELLY [DUKAL LLC] 5 Current NDC, 4 package rows 20241208_0c6474ed-2343-d5f2-e063-6394a90a30b3.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 58 of 68 · 1,343 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 65517-2023-1 65517202301 6 BOX in 1 CASE (65517-2023-1) / 144 PACKET in 1 BOX / 5 g in 1 PACKET 6 box 2023-12-13 No No Current 65517-2023-2 65517202302 144 TUBE in 1 CASE (65517-2023-2) / 28 g in 1 TUBE 144 tube 2024-12-05 No No Current