Triple Antibiotic

Product NDC
70000-0058
Requested package NDC
70000-0058-1
11-digit product format
700000058
Labeler code
70000
Product ID
70000-0058_b4dafaad-ab7e-45e0-9e46-838887ca60da
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc, Neomycin Sulfate, Polymyxin-B Sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Cardinal Health (Leader) 70000
Application
part333B
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-12-31
Marketing end
0000-00-00
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400 [iU]/g; mg/g; [iU]/g
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70000-005870000-0058-1DDiscontinued by firm2026-10-15

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0058-1GM - Gram70000-0058b85d57c1-bb43-461d-887a-a89d16ce5b0512021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0058TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE) OINTMENT [CARDINAL HEALTH (LEADER) 70000]4Legacy NDC20231118_edff4443-d25e-43dc-a788-5ba23d6bf231.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0058-1700000058011 TUBE in 1 CARTON (70000-0058-1) > 28 g in 1 TUBE1 tube2020-12-310000-00-00NoNoCurrent