FDA.reportPublic FDA data

Antibiotic

Product NDC
51316-044
11-digit product format
513160044
Labeler code
51316
Product ID
51316-044_50187929-7372-4b3d-939d-d13be4dc4b51
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc, Polymyxin B Sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
CVS PHARMACY, INC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-02-25
Substance
BACITRACIN ZINC; POLYMYXIN B SULFATE
Active strength
500; 10000 [iU]/g; [iU]/g
Pharmacologic classes
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

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
Antibiotic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC500 [iU]/g
POLYMYXIN B SULFATE10000 [iU]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
89Y4M234ESInternal UNII lookup
19371312D4Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308512Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
32e92acf-2e48-4933-8e08-e1df650e7d19Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-044-01Antibiotic28 g in 1 TUBEOINTMENT283
51316-044-01Antibiotic1 in 1 CARTONOINTMENT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-044ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE) OINTMENT [CVS PHARMACY, INC]3Current NDC, Legacy NDC, 2 package rows20240316_32e92acf-2e48-4933-8e08-e1df650e7d19.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 3 of 22 · 434 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medi First Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEUnifirst First Aid Corporation545fa5b6-781c-18ae-e063-6294a90a2f0d2026-06-16WarningsExact identifier
application number: M004
Triple AntibioticFIRST AID ANTIBIOTIC ORIGINAL STRENGTHAldermed Inc.19eace87-b505-4be6-93b3-db5323e342162026-06-12WarningsExact identifier
application number: M004
BacitracinBACITRACINAlderMed Inc.3f0eb4a0-f7bf-45f7-8885-92c65a4bd8992026-06-08WarningsExact identifier
application number: M004
Bacitracin ZincFIRST AID ANTIBIOTICAldermed Inc.7f4bff4f-588d-4e45-8aa3-f95b4d746f252026-06-08WarningsExact identifier
application number: M004
Triple Antibiotic First Aid Antibiotic plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCLAldermed Inc.5bfc7776-1030-48ba-9df4-897c4984c9e62026-06-08WarningsExact identifier
application number: M004
Triple Antibiotic Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.4545c043-8e8e-4288-b4d8-e6ec9d72f9792026-06-04WarningsExact identifier
application number: M004
First Aid Kit, Orazen Inc5 ADHESIVE BANDAGES, 2 ANTIBIOTIC OINTMENTSOrazen Inc525bcb89-af5b-8652-e063-6294a90a41a62026-06-03WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATESun Pharmaceutical Industries, Inc.d77239e6-5e81-439a-b0cd-f8be591694422026-06-02WarningsExact identifier
application number: M004
First Aid AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BHyVee Inc3ac9f0fc-e08c-49d9-9079-3ba0393c612b2026-06-02WarningsExact identifier
application number: M004
Triple Antibiotic Plus Pain ReliefBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCLHyVee Inc69a4b642-b7ec-43cc-aa57-6858da0b3d632026-06-02WarningsExact identifier
application number: M004
Careland Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEPlanet (Anhui) Pharmaceutical Co., Ltd.0e64179d-fce2-48fc-833e-ce43a54b987c2026-05-31WarningsExact identifier
application number: M004
First Aid AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEHubei Fanjian Medical Product Co.,Ltdf44ab989-c618-1831-e053-2995a90adc8e2026-05-28WarningsExact identifier
application number: M004
Vitastem-tetracycline hydrochlorideTETRACYCLINE HYDROCHLORIDEViaDerma Distribution, Inc.7ffe82a4-864b-48c7-9307-d262f20ca01e2026-05-26WarningsExact identifier
application number: M004
Viaderma Vitastem First Aid Topical AntibioticTETRACYCLINE HYDROCHLORIDEVIADERMA DISTRIBUTION INC6eb04a76-7995-4df6-9c9b-dd450537e5382026-05-26WarningsExact identifier
application number: M004
Medi-First Bacitracin ZincBACITRACINUnifirst First Aid Corporation54609a4f-0fe9-b750-e063-6394a90ae9ce2026-05-26WarningsExact identifier
application number: M004
Hand SanALCOHOLRochester Midland Corporation2d89982d-d1fd-4a98-8b44-c2ae3545be582026-05-14WarningsExact identifier
application number: M004
first aid antibioticBACITRACINHyVee Inc97c87111-260a-48d0-92cd-e22f55a48c7d2026-05-12WarningsExact identifier
application number: M004
triple antibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEWalgreens Co.32df5cca-77bc-45d2-b1f6-2cfdfc371ea92026-05-12WarningsExact identifier
application number: M004
ANTIBIOTIC Maximum StrengthBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEWalgreens Co.653c88bf-5b7d-45be-a131-d59990573e9c2026-05-12WarningsExact identifier
application number: M004
Fresh StartCHLOROXYLENOLPro Chem, Inc.dd1708d8-0bb2-c96a-e053-2995a90a5b862026-05-11WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308512bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical OintmentPSN32e92acf-2e48-4933-8e08-e1df650e7d193
308512bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Topical OintmentSCD32e92acf-2e48-4933-8e08-e1df650e7d193
308512bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical OintmentSY32e92acf-2e48-4933-8e08-e1df650e7d193

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51316-044-01513160044011 TUBE in 1 CARTON (51316-044-01) / 28 g in 1 TUBE1 tube2022-02-250000-00-00NoNoCurrent