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 21 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Bacitracin ZincBACITRACIN ZINCCardinal Health 110 dba LEADERa353dce2-8ae5-23aa-e053-2a95a90a89c22024-01-02WarningsExact identifier
application number: M004
Triple AntibioticPOLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATENuCare Pharmaceuticals,Inc.0dfe5f6a-6968-68e6-e063-6294a90ae25b2024-01-02WarningsExact identifier
application number: M004
BacitracinBACITRACINProficient Rx LPe1166948-5d80-44c2-a20d-78be631647d92024-01-01WarningsExact identifier
application number: M004
TRIPLE ANTIBIOTICBACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATEProficient Rx LP949c5b44-ee52-4913-8872-39181d3199982024-01-01WarningsExact identifier
application number: M004
Triple Antibiotic PlusPOLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, PRAMOXINE HCLCosette Pharmaceuticals, Inc.69d911c2-cb89-2241-35f8-c83acfe182492023-12-21WarningsExact identifier
application number: M004
BacitracinBACITRACINCosette Pharmaceuticals, Inc.630e0841-baf2-e9fa-b309-ad1a5f95da3b2023-12-20WarningsExact identifier
application number: M004
Triple AntibioticPOLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATECosette Pharmaceuticals, Inc.39893365-c94f-bc83-67f6-0005d5f2aa242023-12-20WarningsExact identifier
application number: M004
Triple AntibioticPOLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATEProficient Rx LP524d65e7-9dc6-47b0-a924-46a765fa18692023-12-01WarningsExact identifier
application number: M004
ViabeclineTETRACYCLINE HYDROCHLORIDEAccuria, LLC9fd7041a-6c23-4332-90fe-759bb4aea2ae2023-12-01WarningsExact identifier
application number: M004
BacitracinBACITRACINProficient Rx LP65f8fd49-1882-4eac-9c0e-d63968da33d42023-12-01WarningsExact identifier
application number: M004
Genuine First Aid AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEGFA Production(Xiamen) Co.,Ltd0aaee474-cf35-8b39-e063-6294a90a815c2023-11-21WarningsExact identifier
application number: M004
Sheffield Bacitracin ZincBACITRACIN ZINCSheffield Pharmaceuticals LLC0f446f48-f55d-4de7-b447-285d7a329c842023-11-20WarningsExact identifier
application number: M004
Sheffield Triple Antibiotic Plus Pain ReliefBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDESheffield Pharmaceuticals LLC485a779c-017b-4064-a446-e5073c1bdb072023-11-20WarningsExact identifier
application number: M004
BacitracinBACITRACINBluePoint Laboratoriesb4d8ef06-6269-68f7-e053-2995a90ac8ea2023-11-17WarningsExact identifier
application number: M004
Bacitracin ZincFIRST AID ANTIBIOTICBluePoint Laboratoriesd914abe1-5e14-5673-e053-2a95a90ac91b2023-11-17WarningsExact identifier
application number: M004
EVERLIT CARE Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEEVERLIT GLOBAL INC.e9157891-fc05-41a1-8a86-761a9ae56f8a2023-11-14WarningsExact identifier
application number: M004
CR-371059 Tolnaftate 1%CR-371059 TOLNAFTATE 1%A-S Medication Solutionsbb4e4612-850c-4863-954d-7ad0500b9c052023-11-01WarningsExact identifier
application number: M004
Isopropyl AlcoholISOPROPYL ALCOHOLA-S Medication Solutionsb44b07a0-91ff-476a-ae0a-080fa01917772023-10-31WarningsExact identifier
application number: M004
Family wellnessBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEFRONT PHARMACEUTICAL PLCbd3b8146-6271-488d-bf79-0bb659123b312023-10-27WarningsExact identifier
application number: M004
Family WellnessBACITRACIN ZINCFRONT PHARMACEUTICAL PLCdfc148c1-d1bb-4230-b8cf-9457b99d4e8a2023-10-27WarningsExact 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