FDA.reportPublic FDA data

PS-2261 Triple Antibiotic, 0.5g

Product NDC
58228-2261
11-digit product format
582282261
Labeler code
58228
Product ID
58228-2261_46013412-e449-b632-e063-6394a90a0b04
Type
HUMAN OTC DRUG
Nonproprietary name
PS-2261 Triple Antibiotic, 0.5g
Dosage form
OINTMENT
Route
TOPICAL
Labeler
ProStat First Aid LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-07-31
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

Additional Listing Data#

Finished product
Yes
Brand name base
PS-2261 Triple Antibiotic, 0.5g
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC400 [iU]/g
NEOMYCIN SULFATE5 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
58228-2261-1PS-2261 Triple Antibiotic, 0.5g10 in 1 BOXOINTMENT103
58228-2261-1PS-2261 Triple Antibiotic, 0.5g1000 in 1 CARTONOINTMENT10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58228-2261PS-2261 TRIPLE ANTIBIOTIC, 0.5G OINTMENT [PROSTAT FIRST AID LLC]2Current NDC, 2 package rows20241127_0072f8de-fc06-d529-e063-6294a90a08db.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 OintmentPSN0072f8de-fc06-d529-e063-6294a90a08db3
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD0072f8de-fc06-d529-e063-6294a90a08db3
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY0072f8de-fc06-d529-e063-6294a90a08db3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58228-2261-1582282261011000 BOX in 1 CARTON (58228-2261-1) / 10 PACKET in 1 BOX / .5 g in 1 PACKET1000 box2023-07-31NoNoCurrent