FDA.reportPublic FDA data

Xpect Triple Antibiotic

Product NDC
42961-222
11-digit product format
429610222
Labeler code
42961
Product ID
42961-222_3857f332-6827-42a6-908f-ce87ed98a5ba
Type
HUMAN OTC DRUG
Nonproprietary name
bacitracin zinc, neomycin sulfate and polymyxin b sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Cintas Corporation
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-05-12
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400; 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

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
42961-222-01Xpect Triple Antibiotic0.7 g in 1 PACKAGEOINTMENT0.74
42961-222-02Xpect Triple Antibiotic10 in 1 BOXOINTMENT104
42961-222-02Xpect Triple Antibiotic0.7 g in 1 PACKETOINTMENT0.74
42961-222-03Xpect Triple Antibiotic0.7 g in 1 PACKETOINTMENT0.74
42961-222-03Xpect Triple Antibiotic20 in 1 BOXOINTMENT204
42961-222-04Xpect Triple Antibiotic0.7 g in 1 PACKETOINTMENT0.74
42961-222-04Xpect Triple Antibiotic144 in 1 BOXOINTMENT1444

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42961-222XPECT TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE) OINTMENT [CINTAS CORPORATION]3Current NDC, Legacy NDC, 7 package rows20241228_82ae58a5-b2cd-48b8-a265-f5fbc5ac035c.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 OintmentPSN82ae58a5-b2cd-48b8-a265-f5fbc5ac035c4
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD82ae58a5-b2cd-48b8-a265-f5fbc5ac035c4
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY82ae58a5-b2cd-48b8-a265-f5fbc5ac035c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42961-222-0142961022201.7 g in 1 PACKAGE (42961-222-01) 2022-05-200000-00-00NoNoCurrent
42961-222-024296102220210 PACKET in 1 BOX (42961-222-02) / .7 g in 1 PACKET10 packet2022-05-200000-00-00NoNoCurrent
42961-222-034296102220320 PACKET in 1 BOX (42961-222-03) / .7 g in 1 PACKET20 packet2022-05-200000-00-00NoNoCurrent
42961-222-0442961022204144 PACKET in 1 BOX (42961-222-04) / .7 g in 1 PACKET144 packet2022-05-200000-00-00NoNoCurrent