Home NDC 78495-004-01 Princess Petroleum
Product NDC 78495-004
Requested package NDC 78495-004-01
11-digit product format 784950004
Labeler code 78495
Product ID 78495-004_298dabf6-4ce8-7ed2-e063-6394a90a1bdc
Type HUMAN OTC DRUG
Nonproprietary name White Petrolatum
Dosage form JELLY
Route TOPICAL
Labeler Ultra Distributors Inc.
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-12-01
Substance PETROLATUM
Active strength 100 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 Princess Petroleum
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PETROLATUM 100 g/100g
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 78495-004-01 Princess Petroleum 113 g in 1 JAR JELLY 113 2 78495-004-02 Princess Petroleum 170 g in 1 JAR JELLY 170 2 78495-004-03 Princess Petroleum 226 g in 1 JAR JELLY 226 2 78495-004-04 Princess Petroleum 368 g in 1 JAR JELLY 368 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 78495-004 PRINCESS PETROLEUM (WHITE PETROLATUM) JELLY [ULTRA DISTRIBUTORS INC.] 2 Current NDC, Legacy NDC, 4 package rows 20241220_6d9c92bf-9263-40a4-acac-5c3f0b08c69d.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 · 1,346 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 78495-004-01 78495000401 113 g in 1 JAR (78495-004-01) 113 g 2020-12-01 0000-00-00 No No Current