FDA.reportPublic FDA data

Triple Antibiotic

Product NDC
0713-0268
Requested package NDC
0713-0268-31
11-digit product format
007130268
Labeler code
0713
Product ID
0713-0268_0cf1cf3a-c318-a32a-e063-6394a90a884d
Type
HUMAN OTC DRUG
Nonproprietary name
Polymyxin B Sulfate, Bacitracin Zinc and Neomycin Sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1995-01-11
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2022-04-09 23:13 UTC · source 2022-04-08IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
Triple Antibiotic
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
19371312D4Internal UNII lookup
057Y626693Internal UNII lookup
89Y4M234ESInternal 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
39893365-c94f-bc83-67f6-0005d5f2aa24Available 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
0713-0268-312022-08-19C16284748780-19d75b9d1-0873-f424-e053-dadaa90a57ceTriple Antibiotic Ointment First Aid Antibiotic Ointment
0713-0268-312020-01-31C16284748780-19d75b9d1-0873-f424-e053-dadaa90a57ceTriple Antibiotic Ointment First Aid Antibiotic Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0713-0268-31Triple Antibiotic28.4 g in 1 TUBEOINTMENT28.43
0713-0268-31Triple Antibiotic1 in 1 CARTONOINTMENT13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0268-31GM - Gram0713-026811922163-2c1a-4c42-8a3d-cbcd9eda8e9512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Bacitracin ZincACTIVE INGREDIENT89Y4M234ESTRIPLE ANTIBIOTIC OINTMENT (POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE) OINTMENT [G&W LABORATORIES, INC.]1
NeomycinACTIVE INGREDIENTI16QD7X297TRIPLE ANTIBIOTIC OINTMENT (POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE) OINTMENT [G&W LABORATORIES, INC.]1
Polymyxin B SulfateACTIVE INGREDIENT19371312D4TRIPLE ANTIBIOTIC OINTMENT (POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE) OINTMENT [G&W LABORATORIES, INC.]1
BacitracinACTIVE MOIETY58H6RWO52ITRIPLE ANTIBIOTIC OINTMENT (POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE) OINTMENT [G&W LABORATORIES, INC.]1
NeomycinACTIVE MOIETYI16QD7X297TRIPLE ANTIBIOTIC OINTMENT (POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE) OINTMENT [G&W LABORATORIES, INC.]1
Polymyxin BACTIVE MOIETYJ2VZ07J96KTRIPLE ANTIBIOTIC OINTMENT (POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE) OINTMENT [G&W LABORATORIES, INC.]1
Light Mineral OilINACTIVE INGREDIENTN6K5787QVPTRIPLE ANTIBIOTIC OINTMENT (POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE) OINTMENT [G&W LABORATORIES, INC.]1
PetrolatumINACTIVE INGREDIENT4T6H12BN9UTRIPLE ANTIBIOTIC OINTMENT (POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE) OINTMENT [G&W LABORATORIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0268TRIPLE ANTIBIOTIC (POLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATE) OINTMENT [COSETTE PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 2 package rows20231221_39893365-c94f-bc83-67f6-0005d5f2aa24.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 · 437 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATENuCare Pharmaceutical, Inc.5b14499e-e45c-7c05-e063-6294a90a1cc22026-09-09WarningsExact identifier
application number: M004
American Safety and First Aid Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOrazen Inceb0df2da-1688-c477-e053-2995a90a74a22026-09-07WarningsExact identifier
application number: M004
American Safety and First Aid Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOrazen Inceb0d108f-42bf-3364-e053-2a95a90a45422026-09-07WarningsExact identifier
application number: M004
MEDI-FIRSTBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOrazen Incf4e4d0a4-b90c-99b0-e053-2995a90ab4232026-09-04WarningsExact identifier
application number: M004
Lil Drug Store Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEORAZEN INCe6e5263b-328f-4775-9fac-34302f050ce02026-09-04WarningsExact identifier
application number: M004
MEDI-FIRSTBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOrazen Incf4e42c5c-e080-4efb-e053-2a95a90af52e2026-09-04WarningsExact identifier
application number: M004
MEDI-FIRSTBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOrazen Incf4e4854a-ee01-df72-e053-2995a90aa8ea2026-09-04WarningsExact identifier
application number: M004
Circle K Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEORAZEN INC84c3f7e4-b28b-40bb-8d9d-7c8d679e3a3a2026-09-04WarningsExact identifier
application number: M004
First Aid AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCLWalgreen Companyb982091a-5aa0-4bbc-bb1d-08016f6d0a702026-09-03WarningsExact identifier
application number: M004
SurviveX Triple AntibioticTRIPLE ANTIBIOTICNantong Health & Beyond Hygienic Products Inc.5a7cb52d-a60c-b947-e063-6394a90afb0d2026-09-02WarningsExact identifier
application number: M004
triple antibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BWalgreen Company4f3cfe39-2df8-48b4-954d-5997217c92ba2026-08-31WarningsExact identifier
application number: M004
First Aid AntibioticBACITRACIN ZINCNINGBO TIANBO FIRST AID PRODUCT CO., LTD.217aa2b8-94f5-468a-99b4-52824a77b5732026-08-28WarningsExact identifier
application number: M004
OP Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEYiwu Ori-Power Medtech Co., Ltd.03f3cce9-7e9f-90a6-e063-6294a90a660b2026-08-28WarningsExact identifier
application number: M004
Alcare Extra Hand SanitizerALCOHOLSC Johnson Professional USA Inc.5dc007a2-61fa-4115-a82c-1aa489a6bd392026-08-27WarningsExact identifier
application number: M004
InstantFoam Complete PUREALCOHOLSC Johnson Professional USA Inc.398ca23c-7202-4670-be14-9829675f71742026-08-27WarningsExact identifier
application number: M004
Be Smart Get Prepared Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATETotal Resources International, Inc57ed1a03-7e1b-4eb4-8001-dfd118805edc2026-08-24WarningsExact identifier
application number: M004
ClaravieBACITRACIN ZINCGentell LLC59c5a363-6d79-d07e-e063-6294a90a87532026-08-24WarningsExact identifier
application number: M004
ClaravieBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN BGentell LLC597cb2f0-ff05-a1ab-e063-6294a90acda92026-08-20WarningsExact identifier
application number: M004
Medpride First AidBACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATEShield Line LLC5ba3e703-7873-4724-a0bf-bb22d8a257482026-08-18WarningsExact identifier
application number: M004
Medpride First AidBACITRACIN ZINCShield Line LLCe6a6fb0f-5ab7-4647-84a0-7b9948eed3032026-08-18WarningsExact 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 OintmentPSNe115d413-e41c-4e43-8184-493d64dfcd9f16
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCDe115d413-e41c-4e43-8184-493d64dfcd9f16
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSYe115d413-e41c-4e43-8184-493d64dfcd9f16
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSN39893365-c94f-bc83-67f6-0005d5f2aa243
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD39893365-c94f-bc83-67f6-0005d5f2aa243
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY39893365-c94f-bc83-67f6-0005d5f2aa243
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSN524d65e7-9dc6-47b0-a924-46a765fa18692
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD524d65e7-9dc6-47b0-a924-46a765fa18692
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY524d65e7-9dc6-47b0-a924-46a765fa18692
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSN0dfe5f6a-6968-68e6-e063-6294a90ae25b1
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD0dfe5f6a-6968-68e6-e063-6294a90ae25b1
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY0dfe5f6a-6968-68e6-e063-6294a90ae25b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0713-0268-31007130268311 TUBE in 1 CARTON (0713-0268-31) / 28.4 g in 1 TUBE1 tube1995-01-110000-00-00NoNoCurrent