Home NDC 57337-161-01 Petroleum Jelly Fragrance Free 3.53oz
Product NDC 57337-161
Requested package NDC 57337-161-01
11-digit product format 573370161
Labeler code 57337
Product ID 57337-161_43569a51-3085-cb26-e063-6394a90a8a0d
Type HUMAN OTC DRUG
Nonproprietary name Petrolatum
Dosage form OINTMENT
Route TOPICAL
Labeler Rejoice International Corp.
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-03-06
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 Petroleum Jelly Fragrance Free 3.53oz
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 57337-161-01 Petroleum Jelly Fragrance Free 3.53oz 100 g in 1 JAR OINTMENT 100 3
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 51 of 68 · 1,350 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 57337-161-01 57337016101 100 g in 1 JAR (57337-161-01) 100 g 2024-03-06 No No Current