FDA.reportPublic FDA data

Xpect Triple Antibiotic

Product NDC
42961-236
11-digit product format
429610236
Labeler code
42961
Product ID
42961-236_a3c837b5-b59a-4853-979e-dca5ec565cf9
Type
HUMAN OTC DRUG
Nonproprietary name
bacitracin zinc, neomycin sulfate, polymyxin b sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Cintas Corporation
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-09-13
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400; 3.5; 5000 [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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Xpect Triple Antibiotic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC400 [iU]/g
NEOMYCIN SULFATE3.5 mg/g
POLYMYXIN B SULFATE5000 [iU]/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii89Y4M234ES, 057Y626693, 19371312D4
Rxcui204602

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42961-236-01Xpect Triple Antibiotic0.7 g in 1 PACKETOINTMENT0.73
42961-236-02Xpect Triple Antibiotic10 in 1 BOXOINTMENT103
42961-236-03Xpect Triple Antibiotic20 in 1 BOXOINTMENT203
42961-236-04Xpect Triple Antibiotic10 in 1 BAGOINTMENT103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42961-236XPECT TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [CINTAS CORPORATION]2Current NDC, 4 package rows20241228_39355db3-24d7-485f-9ce0-f0e466e96593.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSN39355db3-24d7-485f-9ce0-f0e466e965933
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD39355db3-24d7-485f-9ce0-f0e466e965933
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY39355db3-24d7-485f-9ce0-f0e466e965933

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42961-236-01429610236010.7 g in 1 PACKET0.7 gHistorical
42961-236-024296102360210 PACKET in 1 BOX (42961-236-02) / .7 g in 1 PACKET (42961-236-01) 10 packet2023-09-13NoNoCurrent
42961-236-034296102360320 PACKET in 1 BOX (42961-236-03) / .7 g in 1 PACKET (42961-236-01) 20 packet2023-09-13NoNoCurrent
42961-236-044296102360410 PACKET in 1 BAG (42961-236-04) / .7 g in 1 PACKET (42961-236-01) 10 packet2025-09-26NoNoCurrent