FDA.reportPublic FDA data

Medpride

Product NDC
52410-3025
11-digit product format
524103025
Labeler code
52410
Product ID
52410-3025_3c6f07bb-e49f-764b-e063-6394a90a247f
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Shield Line LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-05-17
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/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
Medpride
Brand name suffix
First Aid
Listing expiration
2026-12-31

Active Ingredients#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52410-3025-22023-08-22C16284748780-10191ceaa-6342-198a-e063-dbdaa90aec3eMedpride Triple Antibiotic
52410-3025-32023-08-22C16284748780-10191ceaa-6342-198a-e063-dbdaa90aec3eMedpride Triple Antibiotic
52410-3025-42023-08-22C16284748780-10191ceaa-6342-198a-e063-dbdaa90aec3eMedpride Triple Antibiotic
52410-3025-52023-08-22C16284748780-10191ceaa-6342-198a-e063-dbdaa90aec3eMedpride Triple Antibiotic
52410-3025-22023-07-28C16284748780-10191ceaa-6342-198a-e063-dbdaa90aec3eMedpride Triple Antibiotic
52410-3025-32023-07-28C16284748780-10191ceaa-6342-198a-e063-dbdaa90aec3eMedpride Triple Antibiotic
52410-3025-42023-07-28C16284748780-10191ceaa-6342-198a-e063-dbdaa90aec3eMedpride Triple Antibiotic
52410-3025-52023-07-28C16284748780-10191ceaa-6342-198a-e063-dbdaa90aec3eMedpride Triple Antibiotic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52410-3025-2MedprideFirst Aid0.5 g in 1 PACKETOINTMENT0.512
52410-3025-3MedprideFirst Aid0.9 g in 1 PACKETOINTMENT0.912
52410-3025-4MedprideFirst Aid14 g in 1 TUBEOINTMENT1412
52410-3025-5MedprideFirst Aid28.3 g in 1 TUBEOINTMENT28.312

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ESMEDPRIDE FIRST AID (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) OINTMENT [SHIELD LINE LLC ]2
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693MEDPRIDE FIRST AID (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) OINTMENT [SHIELD LINE LLC ]2
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4MEDPRIDE FIRST AID (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) OINTMENT [SHIELD LINE LLC ]2
BACITRACINACTIVE MOIETY58H6RWO52IMEDPRIDE FIRST AID (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) OINTMENT [SHIELD LINE LLC ]2
NEOMYCINACTIVE MOIETYI16QD7X297MEDPRIDE FIRST AID (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) OINTMENT [SHIELD LINE LLC ]2
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KMEDPRIDE FIRST AID (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) OINTMENT [SHIELD LINE LLC ]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UMEDPRIDE FIRST AID (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) OINTMENT [SHIELD LINE LLC ]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52410-3025MEDPRIDE FIRST AID (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) OINTMENT [SHIELD LINE LLC]11Current NDC, Legacy NDC, 4 package rows20240921_5ba3e703-7873-4724-a0bf-bb22d8a25748.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 OintmentPSN5ba3e703-7873-4724-a0bf-bb22d8a2574812
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD5ba3e703-7873-4724-a0bf-bb22d8a2574812
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY5ba3e703-7873-4724-a0bf-bb22d8a2574812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52410-3025-252410302502.5 g in 1 PACKET (52410-3025-2) 2013-05-170000-00-00NoNoCurrent
52410-3025-352410302503.9 g in 1 PACKET (52410-3025-3) 2013-05-170000-00-00NoNoCurrent
52410-3025-45241030250414 g in 1 TUBE (52410-3025-4) 14 g2013-05-170000-00-00NoNoCurrent
52410-3025-55241030250528.3 g in 1 TUBE (52410-3025-5) 28.3 g2013-05-170000-00-00NoNoCurrent