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 19 of 22 · 422 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrogen PeroxideHYDROGEN PEROXIDEJHK Inc1472c854-09c8-4ad8-b8a6-0235440ac26b2024-04-26WarningsExact identifier
application number: M004
Isopropyl AlcoholISOPROPYL ALCOHOLJHK Incabae6a80-e859-47b5-8e34-d391eb8545832024-04-26WarningsExact identifier
application number: M004
AntisepticBENZALKONIUM CHLORIDE, BENZOCAINEJHK Inc0ac5d890-c262-4a30-9fd8-2de6cb0f76012024-04-25WarningsExact identifier
application number: M004
First Aid Antibiotic Bacitracin Zinc Neomycin Sulfate Polymyxin B SulfateBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEM-star (Hubei) Health&Care Products Co., Ltd.c6f2656e-b822-4d61-b557-dd2046dd51f52024-04-01WarningsExact identifier
application number: M004
AntibioticBACITRACIN ZINC, POLYMYXIN B SULFATECVS PHARMACY, INC32e92acf-2e48-4933-8e08-e1df650e7d192024-03-15WarningsExact identifier
application number: M004
Major BacitracinBACITRACINMajor Pharmaceuticals13288efb-e282-68f8-e063-6294a90ae7122024-03-08WarningsExact identifier
application number: M004
UniShield TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEUnishield00b85d3a-322b-43c1-b022-5f6ed50c66092024-03-02WarningsExact identifier
application number: M004
Triple Antibiotic Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEChain Drug Marketing Association Inc.1277942d-753f-ab69-e063-6394a90a496a2024-02-28WarningsExact identifier
application number: M004
Triple Antibiotic with Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDESafetec of America, Inc.ca1df4a0-844d-4b1d-b972-f2704a8ebbab2024-02-16WarningsExact identifier
application number: M004
Single AntibioticBACITRACIN ZINCSafetec of America, Inc.9993c204-6e61-4da3-90ef-2b7dfa09c9202024-02-14WarningsExact identifier
application number: M004
Single Antibiotic with NeomycinNEOMYCIN SULFATESafetec of Americae989cf7e-f3d1-42d2-af45-fc80095b97cb2024-02-08WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATESafetec of America, Inc.96c41fc1-81f9-4757-abc6-867b5383ed5d2024-02-07WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATESafetec of America, Inc.2c2aa8af-2adb-4f59-ac20-15818d0e28e72024-02-07WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATESafetec of America, Inc.03c05028-5a5f-4690-a836-cc1b1044ab392024-02-05WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATESafetec of America, Inc.59494d5c-dd8a-431c-8e6a-4e1151ba74602024-02-05WarningsExact identifier
application number: M004
Triple AntibioticFIRST AID ANTIBIOTICBluePoint Laboratoriesc47e15bd-1062-4cca-e053-2995a90a90752024-01-31WarningsExact identifier
application number: M004
NeomycinNEOMYCIN OINTMENTDynarex Corporation0f9e087b-6e86-a3c7-e063-6394a90ac8d42024-01-23WarningsExact identifier
application number: M004
Antibiotic and Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDETarget Corporation050be94c-1fbb-4d84-82c6-841aac8f318e2024-01-18WarningsExact identifier
application number: M004
Leader Triple AntibioticFIRST AID TRIPLE ANTIBIOTICCardinal Health 110,Inc.844cd9a1-b68e-47d8-a5eb-c9e880ba019e2024-01-18WarningsExact identifier
application number: M004
Multi-Action Antibiotic and Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE OINTMENTTarget Corporation8fecff32-bd67-4351-90f7-0c28cb335ea32024-01-18WarningsExact 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