Home NDC 77338-162 Petrolatum Jelly
Product NDC 77338-162
11-digit product format 773380162
Labeler code 77338
Product ID 77338-162_16dac8e5-aeb9-592d-e063-6394a90ae2b6
Type HUMAN OTC DRUG
Nonproprietary name Petrolatum
Dosage form JELLY
Route TOPICAL
Labeler ASTONEA LABS PRIVATE LIMITED
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-10-11
Substance PETROLATUM
Active strength 99.6 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 Petrolatum Jelly
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PETROLATUM 99.6 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 1252009 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 77338-162-01 Petrolatum Jelly 100 g in 1 JAR JELLY 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 77338-162 PETROLATUM JELLY (PETROLATUM) JELLY [ASTONEA LABS PRIVATE LIMITED] 1 Current NDC, 1 package rows 20240426_16dac8e5-aeb8-592d-e063-6394a90ae2b6.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 57 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 77338-162-01 77338016201 100 g in 1 JAR (77338-162-01) 100 g 2023-01-01 No No Current