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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
de0b2e06-64bc-78f0-e053-2995a90a39a0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2d352c73-a357-4193-a4de-dfdf9a2ac8e4	Product name	1	20150819

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
77338-303-52	2024-06-25	ASTONEA Bacitracin Zinc
77338-303-53	2024-06-25	ASTONEA Bacitracin Zinc
77338-303-52	2024-01-30	ASTONEA Bacitracin Zinc
77338-303-53	2024-01-30	ASTONEA Bacitracin Zinc

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 5 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ora Zen Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Orazen Inc	abbf8c34-87cb-4366-9840-7264a5114b54	2026-03-11	Warnings	Exact identifier application number: M004
FM-24 FOAMING	CHLOROXYLENOL	People's Janitorial Supply	b3c2e174-6099-ba08-e053-2995a90a7290	2026-03-10	Warnings	Exact identifier application number: M004
doubleantibioticointment	BACITRACIN ZINC, POLYMYXIN B SULFATE	Trifecta Pharmaceuticals USA LLC	4eb5202e-8e5b-6d31-e054-00144ff88e88	2026-03-04	Warnings	Exact identifier application number: M004
Neomycin Sulfate	NEOMYCIN SULFATE	Aldermed Inc.	4978bb06-8b7c-9a44-e063-6294a90ac4cf	2026-02-12	Warnings	Exact identifier application number: M004
TRIPLE ANTIBIOTIC FIRST AID ANTIBIOTIC	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	Natureplex LLC	fbb64891-2219-451d-96b0-e7c0430fadda	2026-02-12	Warnings	Exact identifier application number: M004
Double Antibiotic	BACITRACIN ZINC AND POLYMYXIN B SULFATE	STRATUS PHARMACEUTICALS INC	f64b3564-ea3c-4316-8f00-f92c08dcad35	2026-02-04	Warnings	Exact identifier application number: M004
TheraCare Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, AND PRAMIXINE HCL	Veridian Healthcare	d2374664-4668-4da5-9df7-44e6e421ad54	2026-01-29	Warnings	Exact identifier application number: M004
TheraCare Bacitracin Zinc	FIRST AID ANTIBIOTIC	Veridian Healthcare	8217648d-5acb-4a1e-913f-43695f4e01ad	2026-01-29	Warnings	Exact identifier application number: M004
Equate First Aid Antibiotic Plus Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	WalMart	907d44c5-cbd1-4d13-8c5c-c164f7a536e5	2026-01-29	Warnings	Exact identifier application number: M004
Natureplex Antibiotic plus Pain	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Natureplex, LLC	317acec2-8ab7-4b62-9d72-f98cab4f979c	2026-01-29	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.	ProStat First Aid, LLC.	4963f926-3d48-36de-e063-6294a90a9acc	2026-01-27	Warnings	Exact identifier application number: M004
A-Cute Derm Antisepation	BENZETHONIUM CHLORIDE	ABBE Laboratories, Inc.	d7e69169-dc8a-4ad7-b8bb-d97a5d30cbec	2026-01-24	Warnings	Exact identifier application number: M004
A-Cute Derm B-Kleer	BENZETHONIUM CHLORIDE	ABBE Laboratories, Inc.	544333fe-6c3a-485b-b899-e029d97ea962	2026-01-24	Warnings	Exact identifier application number: M004
Brace Relief	BENZOCAINE	InfaLab,Inc	d7e57d67-4234-44a9-bbd3-72e99cd5bdb3	2026-01-16	Warnings	Exact identifier application number: M004
Benzalkonium Chloride	SANITIZING HAND WIPES	ALO NEW YORK LLC	0e1f57c4-8b46-b8cc-e063-6294a90a0ebb	2026-01-15	Warnings	Exact identifier application number: M004
ViaDerma Care Tetracycline HCl First Aid Antibiotic	TETRACYCLINE HYDROCHLORIDE	ViaDerma Distribution, Inc.	5437777e-7f2b-412d-a2f5-380c09de4b1d	2026-01-14	Warnings	Exact identifier application number: M004
Hermon bed sore and pressure sore cream	CALENDULA OFFICINALIS1X HPUS 1.5%	Beautivity LLC	48053402-b6c8-0443-e063-6294a90abce7	2026-01-10	Warnings	Exact identifier application number: M004
Walgreens Arthritis Pain Relief Capsaicin Analgesic	CAPSAICIN	Walgreen Company	da818dd5-bf64-46c2-a3ad-440b2874edbb	2026-01-09	Warnings	Exact identifier application number: M004
QS Plus Plus Instant Hand Sanitizer	BENZEALKONIUM CHLORIDE	ABC Compounding Co., Inc.	343f9139-47bc-44b0-9da1-d9d6f6334bc7	2026-01-06	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC AND NEOMYCIN AND POLYMYXIN B SULFATE	Melaleuca, Inc.	65ae4607-689d-6056-e053-2a91aa0aff56	2025-12-31	Warnings	Exact identifier application number: M004

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
89Y4M234ES	BACITRACIN ZINC	1405-89-6	BACITRACIN ZINC

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1648110	bacitracin 500 UNT in GM Topical Ointment	PSN	de0b2e06-64bc-78f0-e053-2995a90a39a0	3
1648110	bacitracin 0.5 UNT/MG Topical Ointment	SCD	de0b2e06-64bc-78f0-e053-2995a90a39a0	3
1648110	bacitracin 500 UNT per GM Topical Ointment	SY	de0b2e06-64bc-78f0-e053-2995a90a39a0	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
77338-303-52	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