Home NDC 57337-167 Baby Balm Stick 0.65oz
Product NDC 57337-167
11-digit product format 573370167
Labeler code 57337
Product ID 57337-167_20cf2891-c087-29b4-e063-6294a90a41e8
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 2024-08-29
Substance PETROLATUM
Active strength 30 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 Balm Stick 0.65oz
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PETROLATUM 30 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 417854 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 57337-167-01 Baby Balm Stick 0.65oz 18.4 g in 1 TUBE OINTMENT 18.4 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57337-167 BABY BALM STICK 0.65OZ (PETROLATUM) OINTMENT [REJOICE INTERNATIONAL CORP.] 1 Current NDC, 1 package rows 20240830_20cf3bb8-4ab8-2980-e063-6294a90ad631.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 53 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 Sample Exclude flag Status 57337-167-01 57337016701 18.4 g in 1 TUBE (57337-167-01) 18.4 g 2024-08-29 No No Current