FDA.reportPublic FDA data

Bacitracin

Product NDC
45802-060
11-digit product format
458020060
Labeler code
45802
Product ID
45802-060_61d48c5f-c2a3-449a-ab1e-ade132c03a93
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-06-20
Substance
BACITRACIN
Active strength
500 [USP'U]/g
Pharmacologic classes
Decreased Cell Wall Synthesis & Repair [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
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
Bacitracin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN500 [USP'U]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
58H6RWO52IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1648110Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bebbedf6-dd65-47a4-aa3e-ad197b3e05a1Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-060-01Bacitracin1 in 1 CARTONOINTMENT17
45802-060-01Bacitracin14 g in 1 TUBEOINTMENT147
45802-060-03Bacitracin28 g in 1 TUBEOINTMENT287
45802-060-03Bacitracin1 in 1 CARTONOINTMENT17
45802-060-70Bacitracin0.9 g in 1 PACKETOINTMENT0.97
45802-060-70Bacitracin144 in 1 CARTONOINTMENT1447

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-060-01GM - Gram45802-06006aaf2b2-93c1-45b8-83d1-e9d23faf8b1712013-02-13
45802-060-03GM - Gram45802-060270467c0-25b0-47a2-ae0b-1ff1182d512812013-02-13
45802-060-70EA - Each45802-060bbfda411-51fd-41a5-b803-0eacf6c81bf812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACITRACINACTIVE INGREDIENT58H6RWO52IBACITRACIN OINTMENT [PERRIGO NEW YORK INC]2
BACITRACINACTIVE INGREDIENT58H6RWO52IBACITRACIN OINTMENT [CARDINAL HEALTH]2
BACITRACINACTIVE MOIETY58H6RWO52IBACITRACIN OINTMENT [PERRIGO NEW YORK INC]2
BACITRACINACTIVE MOIETY58H6RWO52IBACITRACIN OINTMENT [CARDINAL HEALTH]2
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPBACITRACIN OINTMENT [PERRIGO NEW YORK INC]2
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPBACITRACIN OINTMENT [CARDINAL HEALTH]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UBACITRACIN OINTMENT [PERRIGO NEW YORK INC]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UBACITRACIN OINTMENT [CARDINAL HEALTH]2
BACITRACINACTIVE INGREDIENT58H6RWO52IBACITRACIN OINTMENT [REBEL DISTRIBUTORS CORP]1
BACITRACINACTIVE MOIETY58H6RWO52IBACITRACIN OINTMENT [REBEL DISTRIBUTORS CORP]1
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPBACITRACIN OINTMENT [REBEL DISTRIBUTORS CORP]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UBACITRACIN OINTMENT [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-060BACITRACIN OINTMENT [PADAGIS ISRAEL PHARMACEUTICALS LTD]7Current NDC, Legacy NDC, 6 package rows20240822_bebbedf6-dd65-47a4-aa3e-ad197b3e05a1.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 9 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antibiotic Maximum StrengthBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEWalgreens9a092f24-65b2-4b57-8103-265ea3e033112025-09-02WarningsExact identifier
application number: M004
AerosootheTRIPLE ANTIBIOTIC OINTMENTAero Healthcare US LLC2287a31c-750c-728d-e054-00144ff88e882025-08-29WarningsExact identifier
application number: M004
Triple Antibiotic Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEChain Drug Marketing Association Inc.3d4b3d73-171a-bc6a-e063-6394a90a69c12025-08-26WarningsExact identifier
application number: M004
Dual Action CreamNEOMYCINSULFATE,POLYMYXINBSULFATE,PRAMOXINEHCLTrifecta Pharmaceutical USA LLCb84015ae-9c76-b1d7-e053-2a95a90a2cc82025-08-23WarningsExact identifier
application number: M004
Natureplex Antibiotic Plus Pain, Itch, Scar ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDENatureplex LLCf0af8829-72fb-46b1-9328-6f4920710bb12025-08-15WarningsExact identifier
application number: M004
PROHEAL TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.6c61d88e-4ced-4468-8f99-91652f7a03e42025-08-13WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEJ&A Digital Inc.9f006f16-083d-4e95-aec2-6ef83405f3932025-08-07WarningsExact identifier
application number: M004
Vitacilina First Aid AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATETaisho Pharmaceutical California Inc.93fb9e05-f78c-4d37-b6f1-926cbcb2e7a72025-08-07WarningsExact identifier
application number: M004
SurviveX Triple AntibioticTRIPLE ANTIBIOTIC OINTMENTNantong Health & Beyond Hygienic Products Inc.3bd25bb6-6486-8a0a-e063-6394a90a085c2025-08-07WarningsExact identifier
application number: M004
Thera Plus Original Strength Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEFOURSTAR GROUP USA, INC.09e8bdb7-dc14-4f28-8306-c0e2bf73f0812025-07-31WarningsExact identifier
application number: M004
BacitracinBACITRACINBryant Ranch Prepack0c081802-429f-468f-9650-293cb7a1ad342025-07-29WarningsExact identifier
application number: M004
health and .beyond Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.0070ea5f-434d-53a7-e063-6294a90abf182025-07-27WarningsExact identifier
application number: M004
health and beyond TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.13cbe416-a146-447d-be36-8b3af9b3c8952025-07-27WarningsExact identifier
application number: M004
AOSI HEALTHCARE TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.70c53369-7cf6-4352-a19f-c85a55c5a4bd2025-07-27WarningsExact identifier
application number: M004
Pomada de SulfaNEOMYCIN SULFATEMenper Distributors, Inc.216f4d22-e5e8-46c8-a4ef-8d1532792b562025-07-22WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATESTRATEGIC SOURCING SERVICES LLC1bda9c30-8fc8-4814-b211-94550672b22f2025-07-21WarningsExact identifier
application number: M004
Triple Antibiotic plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLC6a61c900-2dfc-4c07-8ae5-32ffbd89d2b62025-07-21WarningsExact identifier
application number: M004
FifthPulse Bacitracin Zinc 1ozBACITRACIN ZINCFront Pharmaceutical PLC39f994d4-5f41-fb34-e063-6294a90a45ea2025-07-15WarningsExact identifier
application number: M004
FifthPulse Bacitracin Zinc 4ozBACITRACIN ZINCFront Pharmaceutical PLC39fa0e5f-b794-e1e3-e063-6394a90a4ce32025-07-15WarningsExact identifier
application number: M004
FifthPulse Hydrocortisone 1ozHYDROCORTISONEFront Pharmaceutical PLC39fae2a4-902e-3c88-e063-6394a90acbd52025-07-15WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648110bacitracin 500 UNT in GM Topical OintmentPSN0c081802-429f-468f-9650-293cb7a1ad34100
1648110bacitracin 0.5 UNT/MG Topical OintmentSCD0c081802-429f-468f-9650-293cb7a1ad34100
1648110bacitracin 500 UNT per GM Topical OintmentSY0c081802-429f-468f-9650-293cb7a1ad34100
1648110bacitracin 500 UNT in GM Topical OintmentPSN00747e3a-389c-46bc-b6b9-9b3d1d98dbcf20
1648110bacitracin 0.5 UNT/MG Topical OintmentSCD00747e3a-389c-46bc-b6b9-9b3d1d98dbcf20
1648110bacitracin 500 UNT per GM Topical OintmentSY00747e3a-389c-46bc-b6b9-9b3d1d98dbcf20
1648110bacitracin 500 UNT in GM Topical OintmentPSN64aa660d-2d69-48e8-bd0d-4876815d89ff13
1648110bacitracin 0.5 UNT/MG Topical OintmentSCD64aa660d-2d69-48e8-bd0d-4876815d89ff13
1648110bacitracin 500 UNT per GM Topical OintmentSY64aa660d-2d69-48e8-bd0d-4876815d89ff13
1648110bacitracin 500 UNT in GM Topical OintmentPSNbebbedf6-dd65-47a4-aa3e-ad197b3e05a17
1648110bacitracin 0.5 UNT/MG Topical OintmentSCDbebbedf6-dd65-47a4-aa3e-ad197b3e05a17
1648110bacitracin 500 UNT per GM Topical OintmentSYbebbedf6-dd65-47a4-aa3e-ad197b3e05a17
1648110bacitracin 500 UNT in GM Topical OintmentPSN5b0249c0-c196-4d3c-973f-49bd2d3d4a754
1648110bacitracin 0.5 UNT/MG Topical OintmentSCD5b0249c0-c196-4d3c-973f-49bd2d3d4a754
1648110bacitracin 500 UNT per GM Topical OintmentSY5b0249c0-c196-4d3c-973f-49bd2d3d4a754
1648110bacitracin 500 UNT in GM Topical OintmentPSNc134cfc8-f914-6eb8-e053-2a95a90a3ab01
1648110bacitracin 500 UNT in GM Topical OintmentPSNfea57e0a-c472-4c83-9afd-6765a16600b91
1648110bacitracin 0.5 UNT/MG Topical OintmentSCDc134cfc8-f914-6eb8-e053-2a95a90a3ab01
1648110bacitracin 0.5 UNT/MG Topical OintmentSCDfea57e0a-c472-4c83-9afd-6765a16600b91
1648110bacitracin 500 UNT per GM Topical OintmentSYc134cfc8-f914-6eb8-e053-2a95a90a3ab01
1648110bacitracin 500 UNT per GM Topical OintmentSYfea57e0a-c472-4c83-9afd-6765a16600b91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-060-01458020060011 TUBE in 1 CARTON (45802-060-01) / 14 g in 1 TUBE1 tube2011-09-010000-00-00NoNoCurrent
45802-060-03458020060031 TUBE in 1 CARTON (45802-060-03) / 28 g in 1 TUBE1 tube2011-08-050000-00-00NoNoCurrent
45802-060-7045802006070144 PACKET in 1 CARTON (45802-060-70) / .9 g in 1 PACKET144 packet2011-06-200000-00-00NoNoCurrent