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 18 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Major Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B SULFAT	Major Pharmaceuticals	a6cc3fbc-6302-4033-e053-2a95a90a19f0	2024-09-11	Warnings	Exact identifier application number: M004
Leader Triple antibiotic	BACITRACIN,NEOMYCIN,POLYMXIN	Cardinal Health 110 dba LEADER	2175e00a-bf85-3377-e063-6394a90a916f	2024-09-06	Warnings	Exact identifier application number: M004
Members Mark Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	Sam's West Inc	200f4020-7699-4a9e-8fab-2d3df9e76836	2024-09-05	Warnings	Exact identifier application number: M004
Leader Poly Bacitracin	BACITRACIN ZINC POLYMIXIN B SULFATE	Cardinal Health 110 dba LEADER	20d7624f-cafa-25e1-e063-6394a90a4439	2024-08-29	Warnings	Exact identifier application number: M004
triple antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	Meijer Distribution Inc	edcb423e-b5c2-4e26-8f7f-9b9ee575042c	2024-08-19	Warnings	Exact identifier application number: M004
Major Clotrimazole	CLOTRIMAZOLE	NuCare Pharmaceuticals,Inc.	562dfc9f-1897-330a-e054-00144ff8d46c	2024-08-14	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Wildeman Business Group	1f96450a-3bda-1f0a-e063-6294a90a514f	2024-08-13	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Provision Medical	bbf4b99c-9738-4855-82a6-f4e213924ec9	2024-08-09	Warnings	Exact identifier application number: M004
Tetracyte Topical Tetracycline Hydrochloride	TETRACYCLINE HYDROCHLORIDE	VIADERMA DISTRIBUTION INC	4ac5177d-bb67-45e6-adcf-44f0821746bd	2024-08-01	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	Padagis Israel Pharmaceuticals Ltd	bebbedf6-dd65-47a4-aa3e-ad197b3e05a1	2024-07-31	Warnings	Exact identifier application number: M004
Bacitracin Zinc	BACITRACIN ZINC	Chain Drug Marketing Association Inc.	1cd9ded3-068c-496e-e063-6394a90a6a0b	2024-07-09	Warnings	Exact identifier application number: M004
Anti-Itch with Aloe	HYDROCORTISONE 1%	Chain Drug Marketing Association Inc.	1cbea7cd-03a0-1469-e063-6294a90a7cc1	2024-07-08	Warnings	Exact identifier application number: M004
astonea First Aid	BACITRACIN ZINC	ASTONEA LABS PRIVATE LIMITED	de0b2e06-64bc-78f0-e053-2995a90a39a0	2024-06-25	Warnings	Exact identifier application number: M004 ndc (product): 77338-303
Publix Bacitracin Zinc	BACITRACIN ZINC	PUBLIX SUPER MARKETS, INC.	51f21123-7826-40c9-b2aa-b202125085e2	2024-06-17	Warnings	Exact identifier application number: M004
Publix Triple Antibiotic	BACITRACIN ZINC 400 U, POLYMXYIN B SULFATE 5,000 U, NEOMYCIN SULFATE 3.5MG/G	PUBLIX SUPER MARKETS, INC.	871fa43c-a1be-4c15-bbfa-a998a2d89d2e	2024-06-17	Warnings	Exact identifier application number: M004
Biofreeze Professional	MENTHOL, UNSPECIFIED FORM	NuCare Pharmaceuticals,Inc.	66ff9726-20da-688a-e053-2a91aa0a59ac	2024-06-06	Warnings	Exact identifier application number: M004
QC Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.	Chain Drug Marketing Association	1a1501a4-75b0-5900-e063-6394a90ad77a	2024-06-04	Warnings	Exact identifier application number: M004
Always Save Bacitracin Zinc	BACITRACIN ZINC	Trifecta Pharmaceuticals USA LLC	1a00df31-a38a-fc82-e063-6394a90abbf3	2024-06-03	Warnings	Exact identifier application number: M004
PENTREXCILINA TRIPLE ANTIBIOTIC PLUS PAIN RELIEF	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE	OPMX LLC	7c0d3cdf-af50-4a65-a01b-a33510feeb94	2024-05-17	Warnings	Exact identifier application number: M004
PENIMIXCINA	BACITRACIN, NEOMYCIN SULFATE, POLYMIXIN B SULFATE, PRAMOXINE HYDROCHLORIDE	OPMX LLC	92bcbc02-9683-4117-af2b-6d4687796f1f	2024-05-17	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