Astonea

Product NDC: 77338-302
Requested package NDC: 77338-302-54
11-digit product format: 773380302
Labeler code: 77338
Product ID: 77338-302_e689f398-81f9-c40e-e053-2a95a90ad692
Type: HUMAN OTC DRUG
Nonproprietary name: Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate
Dosage form: OINTMENT
Route: TOPICAL
Labeler: ASTONEA LABS PRIVATE LIMITED
Application: part333B
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2022-05-02
Marketing end: 0000-00-00
Substance: BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength: 400 [USP'U]/g; mg/g; [USP'U]/g
Pharmacologic classes: Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	77338-302	77338-302-54	I	Inactivated by FDA		2026-10-05

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 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	77338-302	77338-302-54	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	77338-302	77338-302-54	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	77338-302	77338-302-54	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
99e684e6-f435-feb8-d2bb-3a546f1cb768	Product name	2	20161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0c	Product name	1	20160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4	Product name	1	20150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
b6082387-f592-1148-0844-bd068fd213fb	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
77338-302-53	2024-06-25	ASTONEA Triple Antibiotic
77338-302-54	2024-06-25	ASTONEA Triple Antibiotic
77338-302-53	2024-01-30	ASTONEA Triple Antibiotic
77338-302-54	2024-01-30	ASTONEA Triple Antibiotic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
77338-302-53	AstoneaFirst Aid	0.9 g in 1 PACKET	OINTMENT	0.9		3
77338-302-54	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
77338-302	ASTONEA FIRST AID (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) OINTMENT [ASTONEA LABS PRIVATE LIMITED]	3	Legacy NDC, 2 package rows	20240627_de0982e3-37ab-a829-e053-2995a90a53e8.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
89Y4M234ES	BACITRACIN ZINC	1405-89-6	BACITRACIN ZINC
057Y626693	NEOMYCIN SULFATE	1405-10-3	NEOMYCIN SULFATE
19371312D4	POLYMYXIN B SULFATE	1405-20-5	POLYMYXIN B SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
204602	bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical Ointment	PSN	de0982e3-37ab-a829-e053-2995a90a53e8	3
204602	bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical Ointment	SCD	de0982e3-37ab-a829-e053-2995a90a53e8	3
204602	bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical Ointment	SY	de0982e3-37ab-a829-e053-2995a90a53e8	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
77338-302-54	77338030254	28.3 g in 1 TUBE (77338-302-54)	28.3 g	2022-05-02	0000-00-00	No	No	Current