Neomycin Sulfate

Product NDC: 87879-003
Requested package NDC: 87879-003-01
11-digit product format: 878790003
Labeler code: 87879
Product ID: 87879-003_573e1ff1-9eee-0b6e-e063-6394a90aaa5f
Type: HUMAN OTC DRUG
Nonproprietary name: Neomycin Sulfate
Dosage form: GRANULE
Route: TOPICAL
Labeler: Shaanxi Shuvita Biotech Co., Ltd
Application: 505G(a)(3)
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2026-07-22
Substance: NEOMYCIN SULFATE
Active strength: 100 kg/100kg
Pharmacologic classes: Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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: Neomycin Sulfate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NEOMYCIN SULFATE	100 kg/100kg

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 SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
573e1fe7-4d9d-0a5f-e063-6394a90a85a8	Available on FDA.report

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Neomycin Sulfate	NEOMYCIN SULFATE	Shaanxi Shuvita Biotech Co., Ltd	573e1fe7-4d9d-0a5f-e063-6394a90a85a8	2026-07-22	Warnings	Exact identifier ndc (package): 87879-003-01 ndc (product): 87879-003 ndc11 (package): 87879000301

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
87879-003-01	87879000301	25 kg in 1 PAIL (87879-003-01)	25 kg	2026-07-22	No	No	Current