Home NDC 77338-307 Astonea
Product NDC 77338-307
11-digit product format 773380307
Labeler code 77338
Product ID 77338-307_1bbb6d64-77d3-86e2-e063-6294a90abdc4
Type HUMAN OTC DRUG
Nonproprietary name White Petrolatum
Dosage form OINTMENT
Route TOPICAL
Labeler ASTONEA LABS PRIVATE LIMITED
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-05-23
Substance PETROLATUM
Active strength 76 g/100g
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 Astonea
Brand name suffix Vitamin A and D
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PETROLATUM 76 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 1049072 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 77338-307-02 AstoneaVitamin A and D 5 g in 1 PACKET OINTMENT 5 2 77338-307-03 AstoneaVitamin A and D 28.3 g in 1 TUBE OINTMENT 28.3 2 77338-307-04 AstoneaVitamin A and D 113 g in 1 TUBE OINTMENT 113 2 77338-307-05 AstoneaVitamin A and D 425 g in 1 JAR OINTMENT 425 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 77338-307 ASTONEA VITAMIN A AND D (WHITE PETROLATUM) OINTMENT [ASTONEA LABS PRIVATE LIMITED] 2 Current NDC, Legacy NDC, 4 package rows 20240627_ef7c357b-5ff6-b9d7-e053-2a95a90a1dcf.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 28 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 Marketing end Sample Exclude flag Status 77338-307-02 77338030702 5 g in 1 PACKET (77338-307-02) 5 g 2013-05-23 0000-00-00 No No Current 77338-307-03 77338030703 28.3 g in 1 TUBE (77338-307-03) 28.3 g 2013-05-23 0000-00-00 No No Current 77338-307-04 77338030704 113 g in 1 TUBE (77338-307-04) 113 g 2013-05-23 0000-00-00 No No Current 77338-307-05 77338030705 425 g in 1 JAR (77338-307-05) 425 g 2013-05-23 0000-00-00 No No Current