FDA.reportPublic FDA data

Triple Antibiotic First Aid

Product NDC
52000-019
11-digit product format
520000019
Labeler code
52000
Product ID
52000-019_d882e909-0266-2490-e053-2995a90a9487
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc, Neomycin and Polymyxin B Sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Universal Distribution Center LLC
Application
part333B
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-04-15
Marketing end
0000-00-00
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400 [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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52000-019IInactivated by FDA2026-10-12
excluded packagepackage52000-01952000-019-37IInactivated by FDA2026-10-12

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 · 10 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52000-019-37d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52000-019-37f5e01cc5f278…a2eaf40c39c3…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage52000-019-378dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage52000-019-37e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage52000-019-379bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
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
52000-019-372025-07-29C16284748780-19d75b9d0-f577-f424-e053-dadaa90a57ceTriple Antibiotic First Aid Ointment
52000-019-372022-02-21C16284748780-19d75b9d0-f577-f424-e053-dadaa90a57ceTriple Antibiotic First Aid Ointment
52000-019-372020-01-31C16284748780-19d75b9d0-f577-f424-e053-dadaa90a57ceTriple Antibiotic First Aid Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-019-36Triple Antibiotic First Aid14 g in 1 TUBEOINTMENT144
52000-019-37Triple Antibiotic First Aid1 in 1 BOXOINTMENT14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ESTRIPLE ANTIBIOTIC FIRST AID (BACITRACIN ZINC, NEOMYCIN AND POLYMYXIN B SULFATE) OINTMENT [UNIVERSAL DISTRIBUTION CENTER LLC]1
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693TRIPLE ANTIBIOTIC FIRST AID (BACITRACIN ZINC, NEOMYCIN AND POLYMYXIN B SULFATE) OINTMENT [UNIVERSAL DISTRIBUTION CENTER LLC]1
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4TRIPLE ANTIBIOTIC FIRST AID (BACITRACIN ZINC, NEOMYCIN AND POLYMYXIN B SULFATE) OINTMENT [UNIVERSAL DISTRIBUTION CENTER LLC]1
BACITRACINACTIVE MOIETY58H6RWO52ITRIPLE ANTIBIOTIC FIRST AID (BACITRACIN ZINC, NEOMYCIN AND POLYMYXIN B SULFATE) OINTMENT [UNIVERSAL DISTRIBUTION CENTER LLC]1
NEOMYCINACTIVE MOIETYI16QD7X297TRIPLE ANTIBIOTIC FIRST AID (BACITRACIN ZINC, NEOMYCIN AND POLYMYXIN B SULFATE) OINTMENT [UNIVERSAL DISTRIBUTION CENTER LLC]1
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KTRIPLE ANTIBIOTIC FIRST AID (BACITRACIN ZINC, NEOMYCIN AND POLYMYXIN B SULFATE) OINTMENT [UNIVERSAL DISTRIBUTION CENTER LLC]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0TRIPLE ANTIBIOTIC FIRST AID (BACITRACIN ZINC, NEOMYCIN AND POLYMYXIN B SULFATE) OINTMENT [UNIVERSAL DISTRIBUTION CENTER LLC]1
COCOA BUTTERINACTIVE INGREDIENT512OYT1CRRTRIPLE ANTIBIOTIC FIRST AID (BACITRACIN ZINC, NEOMYCIN AND POLYMYXIN B SULFATE) OINTMENT [UNIVERSAL DISTRIBUTION CENTER LLC]1
COTTONSEED OILINACTIVE INGREDIENTH3E878020NTRIPLE ANTIBIOTIC FIRST AID (BACITRACIN ZINC, NEOMYCIN AND POLYMYXIN B SULFATE) OINTMENT [UNIVERSAL DISTRIBUTION CENTER LLC]1
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1ETRIPLE ANTIBIOTIC FIRST AID (BACITRACIN ZINC, NEOMYCIN AND POLYMYXIN B SULFATE) OINTMENT [UNIVERSAL DISTRIBUTION CENTER LLC]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UTRIPLE ANTIBIOTIC FIRST AID (BACITRACIN ZINC, NEOMYCIN AND POLYMYXIN B SULFATE) OINTMENT [UNIVERSAL DISTRIBUTION CENTER LLC]1
SODIUM PYRUVATEINACTIVE INGREDIENTPOD38AIF08TRIPLE ANTIBIOTIC FIRST AID (BACITRACIN ZINC, NEOMYCIN AND POLYMYXIN B SULFATE) OINTMENT [UNIVERSAL DISTRIBUTION CENTER LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52000-019TRIPLE ANTIBIOTIC FIRST AID (BACITRACIN ZINC, NEOMYCIN AND POLYMYXIN B SULFATE) OINTMENT [UNIVERSAL DISTRIBUTION CENTER LLC]4Legacy NDC, 2 package rows20241212_dbc66ae7-6c0a-4fc3-b7a7-78e4656a29c0.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 OintmentPSNdbc66ae7-6c0a-4fc3-b7a7-78e4656a29c04
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCDdbc66ae7-6c0a-4fc3-b7a7-78e4656a29c04
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSYdbc66ae7-6c0a-4fc3-b7a7-78e4656a29c04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52000-019-365200000193614 g in 1 TUBE14 gHistorical
52000-019-37520000019371 TUBE in 1 BOX (52000-019-37) > 14 g in 1 TUBE (52000-019-36) 1 tube2022-02-140000-00-00NoNoCurrent