leader triple antibiotic and pain relief

Product NDC: 70000-0390
Requested package NDC: 70000-0390-1
11-digit product format: 700000390
Labeler code: 70000
Product ID: 70000-0390_2fb4e4f2-a5cc-4a7c-9239-ece2c46a8ac0
Type: HUMAN OTC DRUG
Nonproprietary name: Bacitracin, Neomycin, Polymyxin B, Pramoxine HCl
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Cardinal Health 110, LLC. dba Leader
Application: part333B
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2018-12-13
Marketing end: 0000-00-00
Substance: BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Active strength: 500 [USP'U]/g; mg/g; [USP'U]/g; mg/g
NDC exclude flag: No
Listing certified through: 2022-12-31
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70000-0390	70000-0390-1	D	Discontinued by firm		2026-10-12

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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70000-0390	70000-0390-1	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70000-0390	70000-0390-1	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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 NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70000-0390-1	GM - Gram	70000-0390	90b844f2-12e9-47ab-bad4-7422025045f4	1	2019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70000-0390	LEADER TRIPLE ANTIBIOTIC AND PAIN RELIEF (BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) OINTMENT [CARDINAL HEALTH 110, LLC. DBA LEADER]	4	Legacy NDC	20241103_6825fc59-ddc0-435d-b83f-0840f869d288.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
89Y4M234ES	BACITRACIN ZINC	1405-89-6	BACITRACIN ZINC
057Y626693	NEOMYCIN SULFATE	1405-10-3	NEOMYCIN SULFATE
19371312D4	POLYMYXIN B SULFATE	1405-20-5	POLYMYXIN B SULFATE
88AYB867L5	PRAMOXINE HYDROCHLORIDE	637-58-1	PRAMOXINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70000-0390-1	70000039001	1 TUBE in 1 CARTON (70000-0390-1) > 28 g in 1 TUBE	1 tube	2018-12-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cardinal Health Triple Antibiotic Ointment + Pain Relief Drug Facts	Cardinal Health 110, LLC. dba Leader	2024-11-01	HUMAN OTC DRUG LABEL	4