FDA.reportPublic FDA data

Medpride

Product NDC
52410-3035
11-digit product format
524103035
Labeler code
52410
Product ID
52410-3035_59586577-18b5-4710-e063-6294a90a4193
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Shield Line LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-05-30
Substance
BACITRACIN ZINC
Active strength
500 [USP'U]/g
Pharmacologic classes
Decreased Cell Wall Synthesis & Repair [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Medpride
Brand name suffix
First Aid
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC500 [USP'U]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
89Y4M234ESInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1366116Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e6a6fb0f-5ab7-4647-84a0-7b9948eed303Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
52410-3035-22024-02-07Medpride Bacitracin Zinc
52410-3035-22024-02-07Medpride Bacitracin Zinc
52410-3035-32024-02-07Medpride Bacitracin Zinc
52410-3035-32024-02-07Medpride Bacitracin Zinc
52410-3035-42024-02-07Medpride Bacitracin Zinc
52410-3035-42024-02-07Medpride Bacitracin Zinc
52410-3035-52024-02-07Medpride Bacitracin Zinc
52410-3035-52024-02-07Medpride Bacitracin Zinc
52410-3035-62024-02-07Medpride Bacitracin Zinc
52410-3035-62024-02-07Medpride Bacitracin Zinc
52410-3035-22023-07-28Medpride Bacitracin Zinc
52410-3035-22023-07-28Medpride Bacitracin Zinc
52410-3035-32023-07-28Medpride Bacitracin Zinc
52410-3035-32023-07-28Medpride Bacitracin Zinc
52410-3035-42023-07-28Medpride Bacitracin Zinc
52410-3035-42023-07-28Medpride Bacitracin Zinc
52410-3035-52023-07-28Medpride Bacitracin Zinc
52410-3035-52023-07-28Medpride Bacitracin Zinc
52410-3035-62023-07-28Medpride Bacitracin Zinc
52410-3035-62023-07-28Medpride Bacitracin Zinc

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52410-3035-2MedprideFirst Aid0.9 g in 1 PACKETOINTMENT0.911
52410-3035-3MedprideFirst Aid14 g in 1 TUBEOINTMENT1411
52410-3035-4MedprideFirst Aid28 g in 1 TUBEOINTMENT2811
52410-3035-5MedprideFirst Aid113 g in 1 TUBEOINTMENT11311
52410-3035-6MedprideFirst Aid425 g in 1 JAROINTMENT42511

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ESMEDPRIDE FIRST AID (BACITRACIN ZINC) OINTMENT [SHIELD LINE LLC ]1
BACITRACINACTIVE MOIETY58H6RWO52IMEDPRIDE FIRST AID (BACITRACIN ZINC) OINTMENT [SHIELD LINE LLC ]1
LANOLININACTIVE INGREDIENT7EV65EAW6HMEDPRIDE FIRST AID (BACITRACIN ZINC) OINTMENT [SHIELD LINE LLC ]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPMEDPRIDE FIRST AID (BACITRACIN ZINC) OINTMENT [SHIELD LINE LLC ]1
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEMEDPRIDE FIRST AID (BACITRACIN ZINC) OINTMENT [SHIELD LINE LLC ]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UMEDPRIDE FIRST AID (BACITRACIN ZINC) OINTMENT [SHIELD LINE LLC ]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52410-3035MEDPRIDE FIRST AID (BACITRACIN ZINC) OINTMENT [SHIELD LINE LLC]10Current NDC, Legacy NDC, 5 package rows20240921_e6a6fb0f-5ab7-4647-84a0-7b9948eed303.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 13 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Balma Septic Antiseptic Hand WashBENZALKONIUM CHLORIDERochester Midland Corporation1b8e0a27-dcdd-4d07-b0f2-55cf74a9b5282025-01-10WarningsExact identifier
application number: M004
LX0380 Lynx glacier fresh Antiseptic Hand and Body Wash 6380CHLOROXYLENOLABC Compounding Co., Inc.efa3938f-64de-77ba-e053-2a95a90ac8402025-01-10WarningsExact identifier
application number: M004
BacitracinBACITRACINA-S Medication Solutions64aa660d-2d69-48e8-bd0d-4876815d89ff2025-01-08WarningsExact identifier
application number: M004
BacitracinBACITRACINWater-Jel Technologies412928a1-3708-4fa8-99c5-aaa2b079cf6e2025-01-06WarningsExact identifier
application number: M004
AVON HeXashield Triple Antibiotic with Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCLTai Guk Pharm. Co., Ltd.8e0cb861-d8aa-1f71-e053-2a95a90aaa882025-01-01WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATETrifecta Pharmaceuticals USA LLC087694c2-4b1b-e293-e063-6294a90a961f2024-12-31WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATETRIFECTA PHARMACEUTICALS USA LLC0c017b10-29b6-e30f-e063-6294a90a8a3c2024-12-31WarningsExact identifier
application number: M004
Triple Antibiotic and Pain ReliefBACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINETrifecta Pharmaceutical USA LLC0bf08cf6-be3f-f9aa-e063-6294a90a43932024-12-31WarningsExact identifier
application number: M004
Single Antibiotic with BacitracinBACITRACIN ZINCRandob Labs Ltd.2a807f1b-986f-a9ea-e063-6394a90aed252024-12-30WarningsExact identifier
application number: M004
TripleantibioticapainscaritchFAMILY WELLNESS BACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINEHCLTrifecta Pharmaceutical USA LLC935106c6-8a9e-07fa-e053-2a95a90a24842024-12-20WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.TRIFECTA PHARMACEUTICALS USA LLC00c52a31-9bfa-a8bf-e063-6294a90ac4d72024-12-20WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATETrifecta Pharmaceuticals Usa Llcd04b397c-1608-4fd9-be28-ef7285d6a9962024-12-20WarningsExact identifier
application number: M004
TripleantibioticointmentandpainreliefFAMILY WELLNESS BACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINETrifecta Pharmaceutical USA LLC91575333-5268-5d8f-e053-2a95a90a7a892024-12-20WarningsExact identifier
application number: M004
Premier Value Max Strength Antibiotic plus pain reliefPREMIER VALUE NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCLPharmacy Value Alliance LLC9767821e-054b-3bd3-e053-2a95a90a4b0e2024-12-20WarningsExact identifier
application number: M004
Premier Value Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEPremier Value Alliance LLC.ab843664-a1e0-6716-e053-2995a90a20632024-12-20WarningsExact identifier
application number: M004
Premier Value Bacitracin ZincBACITRACIN ZINCPharmacy Value Alliance LLC99d789be-aa85-0917-e053-2a95a90acd132024-12-20WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEPremier Value Alliance LLC.ab863d90-1a8f-3c1f-e053-2a95a90aa0a72024-12-20WarningsExact identifier
application number: M004
Family Wellness First Aid AntibioticFAMILY WELLNESS BACITRACIN ZINC, POLYMYXIN B SULFATETrifecta Pharmaceuticals USA, LLC9157681a-3ed1-096e-e053-2a95a90a05e32024-12-18WarningsExact identifier
application number: M004
Family Wellness OriginalFAMILY WELLNESS BACITRACIN, NEOMYCIN, POLYMYXIN BTrifecta Pharmaceuticals USA LLC.915759af-0d4f-6a87-e053-2a95a90acbd62024-12-18WarningsExact identifier
application number: M004
Family Wellness Pain Scar ItchBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCLTrifecta Pharmaceutical USA LLC9e507ec5-310d-3a21-e053-2a95a90a15a62024-12-18WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1366116bacitracin zinc 500 UNT/GM Topical OintmentPSNe6a6fb0f-5ab7-4647-84a0-7b9948eed30311
1366116bacitracin zinc 0.5 UNT/MG Topical OintmentSCDe6a6fb0f-5ab7-4647-84a0-7b9948eed30311
1366116bacitracin zinc 500 UNT per GM Topical OintmentSYe6a6fb0f-5ab7-4647-84a0-7b9948eed30311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52410-3035-252410303502.9 g in 1 PACKET (52410-3035-2) 2013-05-300000-00-00NoNoCurrent
52410-3035-35241030350314 g in 1 TUBE (52410-3035-3) 14 g2013-05-300000-00-00NoNoCurrent
52410-3035-45241030350428 g in 1 TUBE (52410-3035-4) 28 g2013-05-300000-00-00NoNoCurrent
52410-3035-552410303505113 g in 1 TUBE (52410-3035-5) 113 g2013-05-300000-00-00NoNoCurrent
52410-3035-652410303506425 g in 1 JAR (52410-3035-6) 425 g2013-05-300000-00-00NoNoCurrent