Antibiotic

Product NDC: 55550-730
11-digit product format: 555500730
Labeler code: 55550
Product ID: 55550-730_5cf31e3a-83a6-48dd-9396-dcc812cd8cbf
Type: HUMAN OTC DRUG
Nonproprietary name: neomycin sulfate
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Total Resources International
Application: M004
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-10-07
Substance: NEOMYCIN SULFATE
Active strength: 3.5 mg/g
Pharmacologic classes: Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
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 · 18 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
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55550-730-21	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55550-730-21	`557ba5c1ecfa…`	`9c80585c8c6e…`
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	55550-730-21	`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	55550-730-21	`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	55550-730-21	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	55550-730-21	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	55550-730-21	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	55550-730-21	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	55550-730-21	`8dfbde2a14a4…`	`c9ff85d89658…`

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: Antibiotic
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NEOMYCIN SULFATE	3.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
057Y626693	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311928	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
0725364b-b243-4891-af2f-a6049366d038	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
99e684e6-f435-feb8-d2bb-3a546f1cb768	Product name	2	20161117
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
b6082387-f592-1148-0844-bd068fd213fb	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-10-03	0725364b-b243-4891-af2f-a6049366d038
2024-10-03	0725364b-b243-4891-af2f-a6049366d038
2024-01-30	0725364b-b243-4891-af2f-a6049366d038
2024-01-30	0725364b-b243-4891-af2f-a6049366d038
2022-12-19	0725364b-b243-4891-af2f-a6049366d038
2022-12-19	0725364b-b243-4891-af2f-a6049366d038
2021-01-29	0725364b-b243-4891-af2f-a6049366d038
2021-01-29	0725364b-b243-4891-af2f-a6049366d038

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55550-730-21	Antibiotic	0.9 g in 1 POUCH	OINTMENT	0.9		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55550-730	ANTIBIOTIC (NEOMYCIN SULFATE) OINTMENT [TOTAL RESOURCES INTERNATIONAL]	3	Current NDC, Legacy NDC, 1 package rows	20241004_0725364b-b243-4891-af2f-a6049366d038.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 21 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Leader Bacitracin Zinc	BACITRACIN ZINC	Cardinal Health 110 dba LEADER	a353dce2-8ae5-23aa-e053-2a95a90a89c2	2024-01-02	Warnings	Exact identifier application number: M004
Triple Antibiotic	POLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATE	NuCare Pharmaceuticals,Inc.	0dfe5f6a-6968-68e6-e063-6294a90ae25b	2024-01-02	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	Proficient Rx LP	e1166948-5d80-44c2-a20d-78be631647d9	2024-01-01	Warnings	Exact identifier application number: M004
TRIPLE ANTIBIOTIC	BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE	Proficient Rx LP	949c5b44-ee52-4913-8872-39181d319998	2024-01-01	Warnings	Exact identifier application number: M004
Triple Antibiotic Plus	POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, PRAMOXINE HCL	Cosette Pharmaceuticals, Inc.	69d911c2-cb89-2241-35f8-c83acfe18249	2023-12-21	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	Cosette Pharmaceuticals, Inc.	630e0841-baf2-e9fa-b309-ad1a5f95da3b	2023-12-20	Warnings	Exact identifier application number: M004
Triple Antibiotic	POLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATE	Cosette Pharmaceuticals, Inc.	39893365-c94f-bc83-67f6-0005d5f2aa24	2023-12-20	Warnings	Exact identifier application number: M004
Triple Antibiotic	POLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATE	Proficient Rx LP	524d65e7-9dc6-47b0-a924-46a765fa1869	2023-12-01	Warnings	Exact identifier application number: M004
Viabecline	TETRACYCLINE HYDROCHLORIDE	Accuria, LLC	9fd7041a-6c23-4332-90fe-759bb4aea2ae	2023-12-01	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	Proficient Rx LP	65f8fd49-1882-4eac-9c0e-d63968da33d4	2023-12-01	Warnings	Exact identifier application number: M004
Genuine First Aid Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	GFA Production(Xiamen) Co.,Ltd	0aaee474-cf35-8b39-e063-6294a90a815c	2023-11-21	Warnings	Exact identifier application number: M004
Sheffield Bacitracin Zinc	BACITRACIN ZINC	Sheffield Pharmaceuticals LLC	0f446f48-f55d-4de7-b447-285d7a329c84	2023-11-20	Warnings	Exact identifier application number: M004
Sheffield Triple Antibiotic Plus Pain Relief	BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDE	Sheffield Pharmaceuticals LLC	485a779c-017b-4064-a446-e5073c1bdb07	2023-11-20	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	BluePoint Laboratories	b4d8ef06-6269-68f7-e053-2995a90ac8ea	2023-11-17	Warnings	Exact identifier application number: M004
Bacitracin Zinc	FIRST AID ANTIBIOTIC	BluePoint Laboratories	d914abe1-5e14-5673-e053-2a95a90ac91b	2023-11-17	Warnings	Exact identifier application number: M004
EVERLIT CARE Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	EVERLIT GLOBAL INC.	e9157891-fc05-41a1-8a86-761a9ae56f8a	2023-11-14	Warnings	Exact identifier application number: M004
CR-371059 Tolnaftate 1%	CR-371059 TOLNAFTATE 1%	A-S Medication Solutions	bb4e4612-850c-4863-954d-7ad0500b9c05	2023-11-01	Warnings	Exact identifier application number: M004
Isopropyl Alcohol	ISOPROPYL ALCOHOL	A-S Medication Solutions	b44b07a0-91ff-476a-ae0a-080fa0191777	2023-10-31	Warnings	Exact identifier application number: M004
Family wellness	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	FRONT PHARMACEUTICAL PLC	bd3b8146-6271-488d-bf79-0bb659123b31	2023-10-27	Warnings	Exact identifier application number: M004
Family Wellness	BACITRACIN ZINC	FRONT PHARMACEUTICAL PLC	dfc148c1-d1bb-4230-b8cf-9457b99d4e8a	2023-10-27	Warnings	Exact identifier application number: M004

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
057Y626693	NEOMYCIN SULFATE	1405-10-3	NEOMYCIN SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311928	neomycin 0.35 % Topical Ointment	PSN	0725364b-b243-4891-af2f-a6049366d038	4
311928	neomycin 0.0035 MG/MG Topical Ointment	SCD	0725364b-b243-4891-af2f-a6049366d038	4
311928	neomycin (as neomycin sulfate 5 MG per 1 GM) 3.5 MG per 1 GM Topical Ointment	SY	0725364b-b243-4891-af2f-a6049366d038	4
311928	neomycin 0.35 % Topical Ointment	SY	0725364b-b243-4891-af2f-a6049366d038	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55550-730-21	55550073021	.9 g in 1 POUCH (55550-730-21)	2019-10-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Antibiotic - Total Resources International	Total Resources International	2025-10-10	HUMAN OTC DRUG LABEL	4