Xpect Triple Antibiotic

Product NDC: 42961-222
Requested package NDC: 42961-222-04
11-digit product format: 429610222
Labeler code: 42961
Product ID: 42961-222_3dd76be5-cd85-4c47-b0d0-ff0f24b95a88
Type: HUMAN OTC DRUG
Nonproprietary name: bacitracin zinc, neomycin sulfate and polymyxin b sulfate
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Cintas Corporation
Application: part333B
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2022-05-12
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	42961-222	42961-222-04	D	Discontinued by firm		2026-10-05

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

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
99e684e6-f435-feb8-d2bb-3a546f1cb768	Product name	2	20161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0c	Product name	1	20160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4	Product name	1	20150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
b6082387-f592-1148-0844-bd068fd213fb	Product name	1	20140508

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
42961-222-01	Xpect Triple Antibiotic	0.7 g in 1 PACKAGE	OINTMENT	0.7	4
42961-222-02	Xpect Triple Antibiotic	10 in 1 BOX	OINTMENT	10	4
42961-222-02	Xpect Triple Antibiotic	0.7 g in 1 PACKET	OINTMENT	0.7	4
42961-222-03	Xpect Triple Antibiotic	0.7 g in 1 PACKET	OINTMENT	0.7	4
42961-222-03	Xpect Triple Antibiotic	20 in 1 BOX	OINTMENT	20	4
42961-222-04	Xpect Triple Antibiotic	0.7 g in 1 PACKET	OINTMENT	0.7	4
42961-222-04	Xpect Triple Antibiotic	144 in 1 BOX	OINTMENT	144	4

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42961-222	XPECT TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE) OINTMENT [CINTAS CORPORATION]	3	Legacy NDC, 7 package rows	20241228_82ae58a5-b2cd-48b8-a265-f5fbc5ac035c.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

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
204602	bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical Ointment	PSN	82ae58a5-b2cd-48b8-a265-f5fbc5ac035c	4
204602	bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical Ointment	SCD	82ae58a5-b2cd-48b8-a265-f5fbc5ac035c	4
204602	bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical Ointment	SY	82ae58a5-b2cd-48b8-a265-f5fbc5ac035c	4

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42961-222-04	42961022204	144 PACKET in 1 BOX (42961-222-04) > .7 g in 1 PACKET	144 packet	2022-05-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Xpect Triple Antibiotic	Cintas Corporation \| Water-Jel Technologies	2025-09-26	HUMAN OTC DRUG LABEL	4