FDA.reportPublic FDA data

doubleantibioticointment

Product NDC
69396-029
11-digit product format
693960029
Labeler code
69396
Product ID
69396-029_4c357686-9a96-0131-e063-6294a90abdf1
Type
HUMAN OTC DRUG
Nonproprietary name
bacitracin zinc, polymyxin B sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Trifecta Pharmaceuticals USA LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-05-04
Substance
BACITRACIN ZINC; POLYMYXIN B SULFATE
Active strength
500; 10000 [USP'U]/g; [USP'U]/g
Pharmacologic classes
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
doubleantibioticointment
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC500 [USP'U]/g
POLYMYXIN B SULFATE10000 [USP'U]/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii89Y4M234ES, 19371312D4
Rxcui308512

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-029-22doubleantibioticointment28 g in 1 TUBEOINTMENT287
69396-029-22doubleantibioticointment2 in 1 BOXOINTMENT27
69396-029-30doubleantibioticointment1 in 1 BOXOINTMENT17
69396-029-30doubleantibioticointment28 g in 1 TUBEOINTMENT287

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69396-029-30GM - Gram69396-029a03f5768-570f-4af3-a8d2-84c164f8ef4612018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-029DOUBLEANTIBIOTICOINTMENT (BACITRACIN ZINC, POLYMYXIN B SULFATE) OINTMENT [TRIFECTA PHARMACEUTICALS USA LLC]5Current NDC, Legacy NDC, 4 package rows20241215_4eb5202e-8e5b-6d31-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308512bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical OintmentPSN4eb5202e-8e5b-6d31-e054-00144ff88e887
308512bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Topical OintmentSCD4eb5202e-8e5b-6d31-e054-00144ff88e887
308512bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical OintmentSY4eb5202e-8e5b-6d31-e054-00144ff88e887

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69396-029-22693960029222 TUBE in 1 BOX (69396-029-22) / 28 g in 1 TUBE2 tube2026-03-04NoNoCurrent
69396-029-30693960029301 TUBE in 1 BOX (69396-029-30) / 28 g in 1 TUBE1 tube2017-05-040000-00-00NoNoCurrent