Home NDC 57337-076-01 Baby Petroleum Jelly
Product NDC 57337-076
Requested package NDC 57337-076-01
11-digit product format 573370076
Labeler code 57337
Product ID 57337-076_29a0bb73-acd5-32fc-e063-6394a90ab519
Type HUMAN OTC DRUG
Nonproprietary name white petrolatum
Dosage form CREAM
Route TOPICAL
Labeler Rejoice International Inc.
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-06-15
Substance PETROLATUM
Active strength 99 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 Baby Petroleum Jelly
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PETROLATUM 99 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 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 57337-076-01 Baby Petroleum Jelly 113 g in 1 PACKAGE CREAM 113 7 57337-076-02 Baby Petroleum Jelly 170 g in 1 PACKAGE CREAM 170 7 57337-076-03 Baby Petroleum Jelly 227 g in 1 PACKAGE CREAM 227 7 57337-076-04 Baby Petroleum Jelly 368 g in 1 PACKAGE CREAM 368 7
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57337-076 BABY PETROLEUM JELLY (WHITE PETROLATUM) CREAM [REJOICE INTERNATIONAL INC.] 7 Current NDC, Legacy NDC, 4 package rows 20241222_caf568aa-3889-41ff-835e-875bb6d9ca79.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 38 of 68 · 1,350 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 57337-076-01 57337007601 113 g in 1 PACKAGE (57337-076-01) 113 g 2015-06-15 0000-00-00 No No Current