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 6 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Water-Jel Neomycin Antibiotic	FIRST AID OINTMENT	Water-Jel Technologies	abea91a2-4453-406d-a7ed-3ffc19ef521a	2025-12-31	Warnings	Exact identifier application number: M004
Caring Mill Triple Antibiotic and Pain	PRAMOXINE HYDROCHLORIDE, BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE	FSA Store Inc. (Caring Mills)	3c5b6909-6b30-5256-e063-6294a90a9096	2025-12-29	Warnings	Exact identifier application number: M004
Caring Mills Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	Veridian Healthcare	fbd11419-4513-10d7-e053-6394a90ac82b	2025-12-27	Warnings	Exact identifier application number: M004
Caring Mill Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Veridian Healthcare	8cd0cd64-fe62-4225-8986-5e8641dd6df2	2025-12-22	Warnings	Exact identifier application number: M004
PS-2261 Triple Antibiotic, 0.5g	PS-2261 TRIPLE ANTIBIOTIC, 0.5G	ProStat First Aid LLC	0072f8de-fc06-d529-e063-6294a90a08db	2025-12-15	Warnings	Exact identifier application number: M004
PS - 2895 Triple Antibiotic , 0.5g	PS - 2895 TRIPLE ANTIBIOTIC , 0.5G	Prostat First Aid LLC	0050de33-914b-f76d-e063-6394a90a7fab	2025-12-15	Warnings	Exact identifier application number: M004
Triple Antibiotic	TRIPLE ANTIBIOTIC	ProStat First Aid	f76d7d18-0fa1-d943-e053-6294a90ac20a	2025-12-15	Warnings	Exact identifier application number: M004
Triple Antibiotic	TRIPLE ANTIBIOTIC	Front Line Safety	0f509f96-a083-37d1-e063-6394a90a622c	2025-12-15	Warnings	Exact identifier application number: M004
ElixirTripleGuard Triple Antibiotic	BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B	ELIXIR HEALTHCARE USA, LLC.	43edfb80-4d50-9362-e063-6394a90a2199	2025-12-13	Warnings	Exact identifier application number: M004
El Valle Decolorized Iodine	ALCOHOL	Pharmadel LLC	fd7a227b-536c-b3f7-e053-6394a90a4158	2025-12-04	Warnings	Exact identifier application number: M004
Vitastem First Aid Antibiotic	TETRACYCLINE HYDROCHLORIDE	VIADERMA DISTRIBUTION INC	3970ac49-ab0f-4492-ba61-95a12faed500	2025-12-02	Warnings	Exact identifier application number: M004
Thera Plus Original Strength Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Fourstar Group USA, Inc	2f916502-4daf-4cb9-a638-f37bb96c8077	2025-12-02	Warnings	Exact identifier application number: M004
CAREALL Bacitracin	BACITRACIN ZINC	New World Imports, Inc	ea16e1de-0100-456b-abe6-d33de78221da	2025-12-02	Warnings	Exact identifier application number: M004
Triple Antibiotic Ointment, Circle K	TRIPLE ANTIBIOTIC OINTMENT	Lil' Drug Store Products, Inc.	44e5107e-832a-2ce6-e063-6294a90a711d	2025-12-01	Warnings	Exact identifier application number: M004
Viaderma Care First Aid Antibiotic	BACITRACIN ZINC	VIADERMA DISTRIBUTION INC	0f36f396-e479-486c-b047-2760477609e2	2025-12-01	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	1982b664-e8fd-4030-aa89-f7543e1b487b	2025-12-01	Warnings	Exact identifier application number: M004
CareALL Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	New World Imports, Inc	9c2d417e-6fec-42f4-9f0c-2ec79de9342d	2025-12-01	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	Bryant Ranch Prepack	5b0249c0-c196-4d3c-973f-49bd2d3d4a75	2025-12-01	Warnings	Exact identifier application number: M004
Neosporin Plus Lidocaine	BACITRACIN, NEOMYCIN, POLYMYXIN B, LIDOCAINE	Kenvue Brands LLC	e450b6a1-a8da-e5db-e053-2995a90a0ef0	2025-11-24	Warnings	Exact identifier application number: M004
ElixirZincoCare	ZINC OXIDE 20%	ELIXIR HEALTHCARE USA, LLC.	bac18496-3b76-4faf-abde-968d79b718d8	2025-11-22	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