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: 2026-12-31
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: astonea
Brand name suffix: First Aid
Listing expiration: 2026-12-31

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 1 of 22 · 426 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	Salado Sales, Inc	52e275d3-88c9-47f1-8dcf-68445c7be4a7	2026-08-05	Warnings	Exact identifier application number: M004
Wound Wash Antiseptic Saline with Benzalkonium Chloride	WOUND WASH ANTISEPTIC SALINE WITH BENZALKONIUM CHLORIDE	NeilMed Pharmaceuticals, Inc.	55a1fc63-2527-4033-e054-00144ff8d46c	2026-08-05	Warnings	Exact identifier application number: M004
ProcureTriple Antibiotic Triple Antibiotic	BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B	TWIN MED, LLC	71592776-407b-489c-8cdb-8c0573d844f8	2026-08-03	Warnings	Exact identifier application number: M004
procureFirst Aid Antibio First Aid Antibiotic	BACITRACIN	TWIN MED, LLC	8d19e931-99c4-47b8-b7ec-94c16535166f	2026-08-03	Warnings	Exact identifier application number: M004
TRIPLE ANTIBIOTIC	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Vive Health LLC	236c62bf-3de0-0b3e-e063-6394a90ad6c6	2026-07-21	Warnings	Exact identifier application number: M004
TRIPLE ANTIBIOTIC	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Vive Health LLC	21b38b00-1e64-83d8-e063-6294a90a07bd	2026-07-21	Warnings	Exact identifier application number: M004
DERMFREE Triple Antibiotic	TRIPLE ANTIBIOTIC	Jiangxi Yudexi Pharmaceutical Co., LTD	4a5a5603-3478-5f7a-e063-6294a90acc40	2026-07-21	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN ZINC	Preferred Pharmaceuticals Inc.	e094566b-3b80-45ac-be73-54c798bbb763	2026-07-15	Warnings	Exact identifier application number: M004
CAREALL Bacitracin	BACITRACIN ZINC	New World Imports, Inc	560ba2ca-ad0f-9202-e063-6294a90aaefd	2026-07-14	Warnings	Exact identifier application number: M004
CareALL Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	New World Imports, Inc	561bf89c-ca78-d7e4-e063-6394a90a983f	2026-07-14	Warnings	Exact identifier application number: M004
Good Sense First Aid Antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	L. Perrigo Company	3eadd35c-3df2-4e46-b76d-a6e537895917	2026-07-10	Warnings	Exact identifier application number: M004
CareALL Triple Antibiotic plus Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCL	New World Imports, Inc	561c1e51-19f4-90ce-e063-6294a90a5f9b	2026-07-08	Warnings	Exact identifier application number: M004
Ever Ready First Aid Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	EVER READY FIRST AID	ee1ad6d7-e9c1-2b20-e053-2995a90a3366	2026-07-03	Warnings	Exact identifier application number: M004
Single Antibiotic with bacitracin	BACITRACIN ZINC	Safetec of America	4ae9a105-e3f9-4015-8844-085e0b34cdb6	2026-06-25	Warnings	Exact identifier application number: M004
Antibacterial Hand Wipes (0.13% Benzalkonium Chloride)	BENZALKONIUM CHLORIDE	Eleeo Brands LLC	551baf59-39b9-e994-e063-6294a90a65e6	2026-06-25	Warnings	Exact identifier application number: M004
Medi First Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Unifirst First Aid Corporation	545fa5b6-781c-18ae-e063-6294a90a2f0d	2026-06-16	Warnings	Exact identifier application number: M004
Triple Antibiotic	FIRST AID ANTIBIOTIC ORIGINAL STRENGTH	Aldermed Inc.	19eace87-b505-4be6-93b3-db5323e34216	2026-06-12	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	AlderMed Inc.	3f0eb4a0-f7bf-45f7-8885-92c65a4bd899	2026-06-08	Warnings	Exact identifier application number: M004
Bacitracin Zinc	FIRST AID ANTIBIOTIC	Aldermed Inc.	7f4bff4f-588d-4e45-8aa3-f95b4d746f25	2026-06-08	Warnings	Exact identifier application number: M004
Triple Antibiotic First Aid Antibiotic plus Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCL	Aldermed Inc.	5bfc7776-1030-48ba-9df4-897c4984c9e6	2026-06-08	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