FDA.reportPublic FDA data

Triple Antibiotic

Product NDC
69396-002
11-digit product format
693960002
Labeler code
69396
Product ID
69396-002_4f856706-7fa7-6db6-e063-6394a90a7f31
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin zinc, Neomycin sulfate , Polymyxin B sulfate.
Dosage form
OINTMENT
Route
TOPICAL
Labeler
TRIFECTA PHARMACEUTICALS USA LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-03-10
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Triple Antibiotic
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii89Y4M234ES, 057Y626693, 19371312D4
Rxcui204602

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-002-05Triple Antibiotic1 in 1 BOXOINTMENT122
69396-002-05Triple Antibiotic15 g in 1 TUBEOINTMENT1522
69396-002-09Triple Antibiotic0.9 g in 1 PACKETOINTMENT0.922
69396-002-09Triple Antibiotic144 in 1 BOXOINTMENT14422
69396-002-20Triple Antibiotic28.4 g in 1 TUBEOINTMENT28.422
69396-002-20Triple Antibiotic1 in 1 BOXOINTMENT122
69396-002-22Triple Antibiotic57 g in 1 TUBEOINTMENT5722
69396-002-22Triple Antibiotic1 in 1 BOXOINTMENT122
69396-002-23Triple Antibiotic28.4 g in 1 TUBEOINTMENT28.422
69396-002-23Triple Antibiotic2 in 1 BOXOINTMENT222
69396-002-25Triple Antibiotic0.9 g in 1 PACKETOINTMENT0.922
69396-002-25Triple Antibiotic25 in 1 BOXOINTMENT2522
69396-002-33Triple Antibiotic3 in 1 BOXOINTMENT322
69396-002-33Triple Antibiotic28.4 g in 1 TUBEOINTMENT28.422
69396-002-44Triple Antibiotic4 in 1 BOXOINTMENT422
69396-002-44Triple Antibiotic28.4 g in 1 TUBEOINTMENT28.422

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69396-002-05GM - Gram69396-002e7e3a3e6-1c87-45cd-9e8d-ce4c9b0c91d512023-08-08
69396-002-20GM - Gram69396-00238db99b6-cf5f-4bb6-9420-ca09e4eabb0512018-10-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ESTRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.) OINTMENT [TRIFECTA PHARMACEUTICALS USA LLC]6
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.) OINTMENT [TRIFECTA PHARMACEUTICALS USA LLC]6
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.) OINTMENT [TRIFECTA PHARMACEUTICALS USA LLC]6
BACITRACINACTIVE MOIETY58H6RWO52ITRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.) OINTMENT [TRIFECTA PHARMACEUTICALS USA LLC]6
NEOMYCINACTIVE MOIETYI16QD7X297TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.) OINTMENT [TRIFECTA PHARMACEUTICALS USA LLC]6
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KTRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.) OINTMENT [TRIFECTA PHARMACEUTICALS USA LLC]6
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPTRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.) OINTMENT [TRIFECTA PHARMACEUTICALS USA LLC]6
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UTRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.) OINTMENT [TRIFECTA PHARMACEUTICALS USA LLC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-002TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.) OINTMENT [TRIFECTA PHARMACEUTICALS USA LLC]20Current NDC, Legacy NDC, 16 package rows20250510_23a35ba8-ebc6-4252-bb88-ec237425056c.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 OintmentPSN23a35ba8-ebc6-4252-bb88-ec237425056c22
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD23a35ba8-ebc6-4252-bb88-ec237425056c22
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY23a35ba8-ebc6-4252-bb88-ec237425056c22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69396-002-05693960002051 TUBE in 1 BOX (69396-002-05) / 15 g in 1 TUBE1 tube2016-08-230000-00-00NoNoCurrent
69396-002-0969396000209144 PACKET in 1 BOX (69396-002-09) / .9 g in 1 PACKET144 packet2022-03-090000-00-00NoNoCurrent
69396-002-20693960002201 TUBE in 1 BOX (69396-002-20) / 28.4 g in 1 TUBE1 tube2017-03-130000-00-00NoNoCurrent
69396-002-22693960002221 TUBE in 1 BOX (69396-002-22) / 57 g in 1 TUBE1 tube2022-02-01NoNoCurrent
69396-002-23693960002232 TUBE in 1 BOX (69396-002-23) / 28.4 g in 1 TUBE2 tube2024-02-29NoNoCurrent
69396-002-256939600022525 PACKET in 1 BOX (69396-002-25) / .9 g in 1 PACKET25 packet2023-03-14NoNoCurrent
69396-002-33693960002333 TUBE in 1 BOX (69396-002-33) / 28.4 g in 1 TUBE3 tube2024-03-10NoNoCurrent
69396-002-44693960002444 TUBE in 1 BOX (69396-002-44) / 28.4 g in 1 TUBE4 tube2024-02-29NoNoCurrent