FDA.reportPublic FDA data

ProcureTriple Antibiotic

Product NDC
55681-216
11-digit product format
556810216
Labeler code
55681
Product ID
55681-216_5826cdd2-5b3d-7c2f-e063-6294a90a3fb1
Type
HUMAN OTC DRUG
Nonproprietary name
BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B
Dosage form
OINTMENT
Route
TOPICAL
Labeler
TWIN MED, LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-02-05
Marketing end
2028-02-28
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400; 3.5; 5000 U/g; mg/g; 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
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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage55681-216-01e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage55681-216-019bebd1f3094a…5416666fcb17…

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
ProcureTriple Antibiotic
Brand name suffix
Triple Antibiotic

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC400 U/g
NEOMYCIN SULFATE3.5 mg/g
POLYMYXIN B SULFATE5000 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
71592776-407b-489c-8cdb-8c0573d844f8Available 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#

Effective, Related label table
EffectiveRelated label
2021-09-28Drug Facts
2021-09-28Drug Facts
2020-01-31Drug Facts
2020-01-31Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55681-216-01ProcureTriple AntibioticTriple Antibiotic0.9 g in 1 PACKETOINTMENT0.99
55681-216-02ProcureTriple AntibioticTriple Antibiotic28.3 g in 1 TUBEOINTMENT28.39

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ESPROCURETRIPLE ANTIBIOTIC TRIPLE ANTIBIOTIC (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B) OINTMENT [TWIN MED, LLC]1
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693PROCURETRIPLE ANTIBIOTIC TRIPLE ANTIBIOTIC (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B) OINTMENT [TWIN MED, LLC]1
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4PROCURETRIPLE ANTIBIOTIC TRIPLE ANTIBIOTIC (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B) OINTMENT [TWIN MED, LLC]1
BACITRACINACTIVE MOIETY58H6RWO52IPROCURETRIPLE ANTIBIOTIC TRIPLE ANTIBIOTIC (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B) OINTMENT [TWIN MED, LLC]1
NEOMYCINACTIVE MOIETYI16QD7X297PROCURETRIPLE ANTIBIOTIC TRIPLE ANTIBIOTIC (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B) OINTMENT [TWIN MED, LLC]1
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KPROCURETRIPLE ANTIBIOTIC TRIPLE ANTIBIOTIC (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B) OINTMENT [TWIN MED, LLC]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UPROCURETRIPLE ANTIBIOTIC TRIPLE ANTIBIOTIC (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B) OINTMENT [TWIN MED, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55681-216PROCURETRIPLE ANTIBIOTIC TRIPLE ANTIBIOTIC (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B) OINTMENT [TWIN MED, LLC]8Current NDC, Legacy NDC, 2 package rows20240109_71592776-407b-489c-8cdb-8c0573d844f8.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 12 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.Front Pharmaceutical PLC3244d91e-6c6b-a351-e063-6294a90aa02d2025-04-08WarningsExact identifier
application number: M004
Walgreens Advanced Wound HydrogelALLANTOIN, BENZETHONIUM CHLORIDEWALGREEN COMPANY25c6ada8-4a16-0896-e063-6294a90a0fdb2025-04-08WarningsExact identifier
application number: M004
Honestly Battleborn First Aid for Real ManTETRACYCLINE HYDROCHLORIDEHONESTLY LLC13c1f2df-ba52-45e0-8868-a7518e9cdb552025-04-07WarningsExact identifier
application number: M004
Honestly Battleborn First Aid for Real ManTETRACYCLINE HYDROCHLORIDEHONESTLY LLC93a6e02e-9f4b-4821-afa2-2029769f30882025-04-07WarningsExact identifier
application number: M004
burn gel 01MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OILCosmuses Cosmetics (Ningbo) Co., Ltd.3227bdc9-9323-68eb-e063-6294a90a29d22025-04-06WarningsExact identifier
application number: M004
Vitastem ULTRABACITRACIN ZINCViaDerma Distribution, Incfd96cc09-8522-44a5-b034-0d30e532410d2025-04-03WarningsExact identifier
application number: M004
Vitastem Ultra First Aid AntibioticBACITRACIN ZINCViaderma Distribution Ince6986bf9-22ea-4484-a709-27bc91c9058d2025-03-18WarningsExact identifier
application number: M004
Redicare Triple Antibiotic First AidTRIPLE ANTIBIOTIC FIRST AID OINTMENTRedicare LLC9468979d-446e-e4be-e053-2995a90a3f212025-03-05WarningsExact identifier
application number: M004
Neosporin OriginalBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEKenvue Brands LLC0ad21575-0e2d-24c2-e063-6394a90a616e2025-02-21WarningsExact identifier
application number: M004
The Life Safety Pro Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.64a7331f-98a6-4052-85b9-695c83b3bd162025-02-19WarningsExact identifier
application number: M004
VitastemTETRACYCLINE HYDROCHLORIDEViaDerma Distribution, Inc.a6630858-7038-425f-8a75-bb25f36a0dbe2025-02-18WarningsExact identifier
application number: M004
Sheffield Triple AntibioticBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATESheffield Pharmaceuticals LLC1aa95046-c1f7-4fc7-acac-839065d998f62025-02-17WarningsExact identifier
application number: M004
EquateBACITRACIN ZINC ANTIBIOTIC OINTMENTWalmart Inc.20908780-8803-4e19-e063-6394a90aab872025-02-01WarningsExact identifier
application number: M004
Tetracyte Topical Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEVIADERMA DISTRIBUTION INC0961b097-ba41-40c2-aaec-dd291841bf092025-01-30WarningsExact identifier
application number: M004
AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEWelly Health PBC9446375d-4bb4-4bb1-bdc2-c18e995bfe262025-01-29WarningsExact identifier
application number: M004
FAK Care4 Bus and School Yellow ORM DBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE, ISOPROPYL ALCOHOL, BENZOCAINE, ALCOHOLGFA Production (Xiamen) Co., Ltd.3b5d07c6-bda2-4bc7-89b8-88280d11ed742025-01-22WarningsExact identifier
application number: M004
Members Mark Alcohol Prep Pads, SterileISOPROPYL ALCOHOLSam's Club West Inc.13001877-ae90-40be-899d-fb38f3a38b122025-01-22WarningsExact identifier
application number: M004
Equate Antibiotic Plus Pain, Itch, Scar ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEWalMart2b743271-4f58-4ba1-a04c-560f7f8a547e2025-01-16WarningsExact identifier
application number: M004
Equate Antibiotic Plus Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEWalMarte08b427f-d070-4521-ad3c-faf2955317912025-01-16WarningsExact identifier
application number: M004
NATUREPLEX ANTIBIOTICBACITRACIN ZINC AND POLYMYXIN B SULFATENatureplex LLC86ea3452-c810-4c9a-9f52-bcb0688020f92025-01-15WarningsExact 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 OintmentPSN71592776-407b-489c-8cdb-8c0573d844f89
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD71592776-407b-489c-8cdb-8c0573d844f89
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY71592776-407b-489c-8cdb-8c0573d844f89

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55681-216-0155681021601.9 g in 1 PACKET (55681-216-01) 2021-09-222028-02-28NoNoCurrent
55681-216-025568102160228.3 g in 1 TUBE (55681-216-02) 28.3 g2022-08-182028-02-28NoNoCurrent