FDA.reportPublic FDA data

Triple Antibiotic

Product NDC
53329-087
11-digit product format
533290087
Labeler code
53329
Product ID
53329-087_40c09b61-e011-85ed-e063-6294a90a0d85
Type
HUMAN OTC DRUG
Nonproprietary name
bacitracin zinc, neomycin sulfate, polymyxin B sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Medline Industries, LP
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-01-01
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], 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

Additional Listing Data#

Finished product
Yes
Brand name base
Triple Antibiotic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC400 [USP'U]/g
NEOMYCIN SULFATE3.5 mg/g
POLYMYXIN B SULFATE5000 [USP'U]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
89Y4M234ESInternal UNII lookup
057Y626693Internal 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
204602Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
301ebb9a-033b-4f04-99ff-571e921924caAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
53329-087-012023-08-08087 Curad Triple Antibiotic Ointment
53329-087-012023-08-08087 Curad Triple Antibiotic Ointment
53329-087-872023-08-08087 Curad Triple Antibiotic Ointment
53329-087-872023-08-08087 Curad Triple Antibiotic Ointment
53329-087-962023-08-08087 Curad Triple Antibiotic Ointment
53329-087-962023-08-08087 Curad Triple Antibiotic Ointment
53329-087-012023-07-28087 Curad Triple Antibiotic Ointment
53329-087-012023-07-28087 Curad Triple Antibiotic Ointment
53329-087-872023-07-28087 Curad Triple Antibiotic Ointment
53329-087-872023-07-28087 Curad Triple Antibiotic Ointment
53329-087-962023-07-28087 Curad Triple Antibiotic Ointment
53329-087-962023-07-28087 Curad Triple Antibiotic Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-087-01Triple Antibiotic28.4 g in 1 TUBEOINTMENT28.418
53329-087-01Triple Antibiotic1 in 1 BOXOINTMENT118
53329-087-87Triple Antibiotic0.9 g in 1 PACKETOINTMENT0.918
53329-087-96Triple Antibiotic144 in 1 BOXOINTMENT14418

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53329-087-87EA - Each53329-087a8a17112-3be1-4a4d-a568-ed7ee069673f12018-03-08
53329-087-96EA - Each53329-08738bc23c3-cb05-4b94-a06f-1f44fbc6088112018-03-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ESTRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [MEDLINE INDUSTRIES, INC.]3
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [MEDLINE INDUSTRIES, INC.]3
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [MEDLINE INDUSTRIES, INC.]3
BACITRACINACTIVE MOIETY58H6RWO52ITRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [MEDLINE INDUSTRIES, INC.]3
NEOMYCINACTIVE MOIETYI16QD7X297TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [MEDLINE INDUSTRIES, INC.]3
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KTRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [MEDLINE INDUSTRIES, INC.]3
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UTRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [MEDLINE INDUSTRIES, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-087TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [MEDLINE INDUSTRIES, LP]17Current NDC, Legacy NDC, 4 package rows20241204_301ebb9a-033b-4f04-99ff-571e921924ca.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 1 of 22 · 426 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATESalado Sales, Inc52e275d3-88c9-47f1-8dcf-68445c7be4a72026-08-05WarningsExact identifier
application number: M004
Wound Wash Antiseptic Saline with Benzalkonium ChlorideWOUND WASH ANTISEPTIC SALINE WITH BENZALKONIUM CHLORIDENeilMed Pharmaceuticals, Inc.55a1fc63-2527-4033-e054-00144ff8d46c2026-08-05WarningsExact identifier
application number: M004
ProcureTriple Antibiotic Triple AntibioticBACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN BTWIN MED, LLC71592776-407b-489c-8cdb-8c0573d844f82026-08-03WarningsExact identifier
application number: M004
procureFirst Aid Antibio First Aid AntibioticBACITRACINTWIN MED, LLC8d19e931-99c4-47b8-b7ec-94c16535166f2026-08-03WarningsExact identifier
application number: M004
TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEVive Health LLC236c62bf-3de0-0b3e-e063-6394a90ad6c62026-07-21WarningsExact identifier
application number: M004
TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEVive Health LLC21b38b00-1e64-83d8-e063-6294a90a07bd2026-07-21WarningsExact identifier
application number: M004
DERMFREE Triple AntibioticTRIPLE ANTIBIOTICJiangxi Yudexi Pharmaceutical Co., LTD4a5a5603-3478-5f7a-e063-6294a90acc402026-07-21WarningsExact identifier
application number: M004
BacitracinBACITRACIN ZINCPreferred Pharmaceuticals Inc.e094566b-3b80-45ac-be73-54c798bbb7632026-07-15WarningsExact identifier
application number: M004
CAREALL BacitracinBACITRACIN ZINCNew World Imports, Inc560ba2ca-ad0f-9202-e063-6294a90aaefd2026-07-14WarningsExact identifier
application number: M004
CareALL Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENew World Imports, Inc561bf89c-ca78-d7e4-e063-6394a90a983f2026-07-14WarningsExact identifier
application number: M004
Good Sense First Aid AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BL. Perrigo Company3eadd35c-3df2-4e46-b76d-a6e5378959172026-07-10WarningsExact identifier
application number: M004
CareALL Triple Antibiotic plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCLNew World Imports, Inc561c1e51-19f4-90ce-e063-6294a90a5f9b2026-07-08WarningsExact identifier
application number: M004
Ever Ready First Aid Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEEVER READY FIRST AIDee1ad6d7-e9c1-2b20-e053-2995a90a33662026-07-03WarningsExact identifier
application number: M004
Single Antibiotic with bacitracinBACITRACIN ZINCSafetec of America4ae9a105-e3f9-4015-8844-085e0b34cdb62026-06-25WarningsExact identifier
application number: M004
Antibacterial Hand Wipes (0.13% Benzalkonium Chloride)BENZALKONIUM CHLORIDEEleeo Brands LLC551baf59-39b9-e994-e063-6294a90a65e62026-06-25WarningsExact identifier
application number: M004
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSN301ebb9a-033b-4f04-99ff-571e921924ca18
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD301ebb9a-033b-4f04-99ff-571e921924ca18
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY301ebb9a-033b-4f04-99ff-571e921924ca18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-087-01533290087011 TUBE in 1 BOX (53329-087-01) / 28.4 g in 1 TUBE1 tube2018-01-010000-00-00NoNoCurrent
53329-087-8753329008787.9 g in 1 PACKET (53329-087-87) 2018-01-010000-00-00NoNoCurrent
53329-087-9653329008796144 PACKET in 1 BOX (53329-087-96) / .9 g in 1 PACKET (53329-087-87) 144 packet2018-01-010000-00-00NoNoCurrent