FDA.reportPublic FDA data

Triple Antibiotic

Product NDC
61010-5600
Requested package NDC
61010-5600-1
11-digit product format
610105600
Labeler code
61010
Product ID
61010-5600_10d3b150-077e-cb76-e063-6394a90ab356
Type
HUMAN OTC DRUG
Nonproprietary name
bacitracin zinc, neomycin sulfate, polymyxin b sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Safetec of America, Inc.
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-08-08
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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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, 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
Good Sense First Aid AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BL. Perrigo Company3eadd35c-3df2-4e46-b76d-a6e5378959172026-07-10WarningsExact identifier
application number: M004
WalgreensDIPHENHYDRAMINE HYDROCHLORIDE, IBUPROFEN, HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE, LIDOCAINE HCL, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, ETHYL ALCOHOLWalgreen Co.5630f48b-404c-b847-e063-6394a90a8d8e2026-07-09WarningsExact identifier
ndc (package): 61010-5600-1
ndc11 (package): 61010560001
Care ScienceDIPHENHYDRAMINE HYDROCHLORIDE, IBUPROFEN, HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE, LIDOCAINE HCL, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, ETHYL ALCOHOLASO LLC562f2b2c-d234-e491-e063-6294a90a705f2026-07-08WarningsExact identifier
ndc (package): 61010-5600-1
ndc11 (package): 61010560001
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
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

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
96c41fc1-81f9-4757-abc6-867b5383ed5dAvailable 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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61010-5600-12024-02-13C16284748780-11030e365-68e7-111a-e063-dadaa90a10e261010-5600, Triple Antibiotic Ointment
61010-5600-22024-02-13C16284748780-11030e365-68e7-111a-e063-dadaa90a10e261010-5600, Triple Antibiotic Ointment
61010-5600-32024-02-13C16284748780-11030e365-68e7-111a-e063-dadaa90a10e261010-5600, Triple Antibiotic Ointment
61010-5600-42024-02-13C16284748780-11030e365-68e7-111a-e063-dadaa90a10e261010-5600, Triple Antibiotic Ointment
61010-5600-12024-01-30C16284748780-11030e365-68e7-111a-e063-dadaa90a10e261010-5600, Triple Antibiotic Ointment
61010-5600-22024-01-30C16284748780-11030e365-68e7-111a-e063-dadaa90a10e261010-5600, Triple Antibiotic Ointment
61010-5600-32024-01-30C16284748780-11030e365-68e7-111a-e063-dadaa90a10e261010-5600, Triple Antibiotic Ointment
61010-5600-42024-01-30C16284748780-11030e365-68e7-111a-e063-dadaa90a10e261010-5600, Triple Antibiotic Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61010-5600-1Triple Antibiotic0.9 g in 1 POUCHOINTMENT0.96
61010-5600-2Triple Antibiotic144 in 1 BOXOINTMENT1446
61010-5600-2Triple Antibiotic0.9 g in 1 POUCHOINTMENT0.96
61010-5600-3Triple Antibiotic25 in 1 BOXOINTMENT256
61010-5600-3Triple Antibiotic0.9 g in 1 POUCHOINTMENT0.96
61010-5600-4Triple Antibiotic10 in 1 BOXOINTMENT106
61010-5600-4Triple Antibiotic0.9 g in 1 PACKETOINTMENT0.96

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
bacitracin zincACTIVE INGREDIENT89Y4M234ESTRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [SAFETEC OF AMERICA, INC.]1
neomycin sulfateACTIVE INGREDIENT057Y626693TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [SAFETEC OF AMERICA, INC.]1
polymyxin b sulfateACTIVE INGREDIENT19371312D4TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [SAFETEC OF AMERICA, INC.]1
bacitracin zincACTIVE MOIETY89Y4M234ESTRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [SAFETEC OF AMERICA, INC.]1
neomycinACTIVE MOIETYI16QD7X297TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [SAFETEC OF AMERICA, INC.]1
polymyxin bACTIVE MOIETYJ2VZ07J96KTRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [SAFETEC OF AMERICA, INC.]1
petrolatumINACTIVE INGREDIENT4T6H12BN9UTRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [SAFETEC OF AMERICA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61010-5600TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [SAFETEC OF AMERICA, INC.]6Current NDC, Legacy NDC, 7 package rows20240214_96c41fc1-81f9-4757-abc6-867b5383ed5d.zip
61010-5600CARE SCIENCE ESSENTIAL FIRST AID (ETHYL ALCOHOL, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE) KIT [ASO LLC]3Current NDC, Legacy NDC20240830_4e53fc6b-4774-4224-8759-eadd150ff959.zip
61010-5600CARE SCIENCE OSHA FIRST AID (ETHYL ALCOHOL, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE, DIPHENHYDRAMINE HYDROCHLORIDE, HYDROCORTISONE, IBUPROFEN, ACETAMINOPHEN, WATER) KIT [ASO LLC]2Current NDC, Legacy NDC20241107_1cbace4d-fd0a-41d1-aa71-907d43620bf8.zip

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 OintmentPSN96c41fc1-81f9-4757-abc6-867b5383ed5d6
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD96c41fc1-81f9-4757-abc6-867b5383ed5d6
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY96c41fc1-81f9-4757-abc6-867b5383ed5d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61010-5600-161010560001.9 g in 1 POUCH (61010-5600-1) 2011-08-080000-00-00NoNoCurrent