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 7 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hand-Aid	ALCOHOL	ABC Compounding Co., Inc.	788d7584-bc33-49e8-90fd-767045ea2914	2025-11-19	Warnings	Exact identifier application number: M004
VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC	NEOMYCIN SULFATE	Compania Internacional de Comercio, S.A.P.I de C.V.	ba7a3331-466e-496f-bebd-9ee7067bcdb2	2025-11-19	Warnings	Exact identifier application number: M004
dabur First Aid	BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE	Dabur India Limited	229170a3-ef9e-597d-e063-6394a90acf8b	2025-11-18	Warnings	Exact identifier application number: M004
QS Plus Instant Hand Sanitizer	BENZEALKONIUM CHLORIDE	Romaine Companies	5e16f52d-3bf3-4897-bd3a-cf4e117583c9	2025-11-18	Warnings	Exact identifier application number: M004
Hand Guard Foaming Instant Hand Sanitizer	ALCOHOL	Wechem, Inc.	d9b89f90-aece-48a2-862a-c524d3c90841	2025-11-18	Warnings	Exact identifier application number: M004
Puri-San Plus Instant Hand Sanitizer	BENZEALKONIUM CHLORIDE	People's Janitorial Supply	f0726bdd-9d2b-4383-af10-e2e0c5460e1e	2025-11-18	Warnings	Exact identifier application number: M004
Lynx san a foam	ALCOHOL	ABC Compounding Co., Inc.	2b987ebc-c73b-edbd-e063-6394a90a1d2d	2025-11-18	Warnings	Exact identifier application number: M004
Instant Hand Sanitizer	ALCOHOL	ABC Compounding Co., Inc.	ee46cb57-c79c-4edf-bc88-4a4f8a95bfc8	2025-11-18	Warnings	Exact identifier application number: M004
Rapidol Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Pharmadel LLC	1ad22205-f8c3-b142-e063-6394a90a0044	2025-11-17	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	Kroger	3f860e7f-487b-d706-e063-6394a90a73ad	2025-11-13	Warnings	Exact identifier application number: M004
ElixirBaciShield First Aid	BACITRACIN ZINC	ELIXIR HEALTHCARE USA, LLC.	15e31a2a-01b5-4598-850f-4d0348086b4b	2025-11-12	Warnings	Exact identifier application number: M004
Bacitracin Zinc	BACITRACIN ZINC	Trifecta Pharmaceuticals USA LLC	4352c453-a89c-a2b9-e063-6294a90a61f3	2025-11-11	Warnings	Exact identifier application number: M004
Bacitracin Zinc	BACITRACIN ZINC	Universal Distribution Center LLC	186b2750-5bf6-1702-e063-6294a90a62b3	2025-10-30	Warnings	Exact identifier application number: M004
POMADA SULFA FIRST AID ANTIBIOTIC	NEOMYCIN SULFATE	GRANDALL DISTRIBUTING, LLC	1d8e1fca-6864-7c08-e063-6394a90a08b6	2025-10-28	Warnings	Exact identifier application number: M004
POLVO DE SULFA FIRST AID ANTIBIOTIC	BACITRACIN ZINC, POLYMYXIN B SULFATE	GRANDALL DISTRIBUTING, LLC	1d8e3a03-a39f-a99e-e063-6394a90a31db	2025-10-28	Warnings	Exact identifier application number: M004
EasyTouch Alcohol Prep Pads Sterile	ISOPROPYL ALCOHOL	MHC Medical Products, LLC	fd60ad34-5fd9-4440-9f3f-23beffc19dd9	2025-10-24	Warnings	Exact identifier application number: M004
Gerigentle-Bacitracin zinc	BACITRACIN ZINC	Geri-Gentle Corporation	7e36e4d0-eac3-4aa3-81a7-e21c224b1cd4	2025-10-23	Warnings	Exact identifier application number: M004
Tripleantibioticointmentandpainrelief	BACITRACIN,NEOMYCIN,POLYMXIN, PRAMOXINE	Trifecta Pharmaceuticals USA	54c1d306-dc3b-2885-e054-00144ff8d46c	2025-10-22	Warnings	Exact identifier application number: M004
Zapotol Bacitracin	BACITRACIN	Zapatol Corp.	c8704895-8819-49ac-8baa-5b97be1d00aa	2025-10-22	Warnings	Exact identifier application number: M004
Family Care First Aid	BACITRACIN ZINC	United Exchange Corp.	df27620e-7312-8082-e053-2995a90aaca6	2025-10-21	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