Home NDC 77338-303 astonea
Product NDC 77338-303
11-digit product format 773380303
Labeler code 77338
Product ID 77338-303_1bbae69c-ba20-2fff-e063-6294a90a8232
Type HUMAN OTC DRUG
Nonproprietary name Bacitracin Zinc
Dosage form OINTMENT
Route TOPICAL
Labeler ASTONEA LABS PRIVATE LIMITED
Application M004
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-05-02
Substance BACITRACIN ZINC
Active strength 500 [USP'U]/g
Pharmacologic classes Decreased Cell Wall Synthesis & Repair [PE]
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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 77338-303-52 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 77338-303-53 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 77338-303-52 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 77338-303-53 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 77338-303-52 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 77338-303-53 1332a3947898…d4bfe170f9cd…
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 First Aid
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BACITRACIN ZINC 500 [USP'U]/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 89Y4M234ES Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1648110 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 77338-303-52 astoneaFirst Aid 0.9 g in 1 PACKET OINTMENT 0.9 3 77338-303-53 astoneaFirst Aid 28.3 g in 1 TUBE OINTMENT 28.3 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 77338-303 ASTONEA FIRST AID (BACITRACIN ZINC) OINTMENT [ASTONEA LABS PRIVATE LIMITED] 3 Current NDC, Legacy NDC, 2 package rows 20240627_de0b2e06-64bc-78f0-e053-2995a90a39a0.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 22 of 22 · 424 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Family Wellness Antiseptic and Pain Relief BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE FRONT PHARMACEUTICAL PLC cb7fdcde-2bd8-4834-ba4e-4d6fd1512599 2023-10-26 Warnings Exact identifier application number: M004 GENUINE FIRST AID Antibiotic BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE Nantong Health & Beyond Hygienic Products Inc. 23abfe12-5b50-4b49-878e-4fcdb6c341fd 2023-10-19 Warnings Exact identifier application number: M004 EVERLIT CARE Triple Antibiotic BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE Nantong Health & Beyond Hygienic Products Inc. f4921508-c32f-426f-a2f0-16c3acbd4713 2023-10-14 Warnings Exact identifier application number: M004 Cuadriderma BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE ProMex LLC 4fa99b96-ab4b-4523-82bc-343dbaf39fb6 2022-01-25 Warnings Exact identifier application number: M004
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 77338-303-52 77338030352 .9 g in 1 PACKET (77338-303-52) 2022-05-02 0000-00-00 No No Current 77338-303-53 77338030353 28.3 g in 1 TUBE (77338-303-53) 28.3 g 2022-05-02 0000-00-00 No No Current