FDA.reportPublic FDA data

Triple Antibiotic

Product NDC
68001-483
11-digit product format
680010483
Labeler code
68001
Product ID
68001-483_0b26450d-312b-fef1-e063-6394a90a7f6f
Type
HUMAN OTC DRUG
Nonproprietary name
First Aid Antibiotic
Dosage form
OINTMENT
Route
TOPICAL
Labeler
BluePoint Laboratories
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-06-15
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400; 3.5; 5000 [iU]/g; mg/g; [iU]/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

Additional Listing Data#

Finished product
Yes
Brand name base
Triple Antibiotic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC400 [iU]/g
NEOMYCIN SULFATE3.5 mg/g
POLYMYXIN B SULFATE5000 [iU]/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
68001-483-45Triple Antibiotic1 in 1 CARTONOINTMENT14
68001-483-45Triple Antibiotic28.4 g in 1 TUBEOINTMENT28.44
68001-483-46Triple Antibiotic1 in 1 CARTONOINTMENT14
68001-483-46Triple Antibiotic14.2 g in 1 TUBEOINTMENT14.24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-483-45GM - Gram68001-483451ec1f8-cc5e-4a12-bb3c-93c2cc42f36112021-09-07
68001-483-46GM - Gram68001-483aedbc1cd-23c3-4f8d-aa20-0d24ac8369a312021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-483TRIPLE ANTIBIOTIC (FIRST AID ANTIBIOTIC) OINTMENT [BLUEPOINT LABORATORIES]4Current NDC, Legacy NDC, 4 package rows20240202_c47e15bd-1062-4cca-e053-2995a90a9075.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 OintmentPSNc47e15bd-1062-4cca-e053-2995a90a90754
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCDc47e15bd-1062-4cca-e053-2995a90a90754
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSYc47e15bd-1062-4cca-e053-2995a90a90754

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-483-45680010483451 TUBE in 1 CARTON (68001-483-45) / 28.4 g in 1 TUBE1 tube2021-06-150000-00-00NoNoCurrent
68001-483-46680010483461 TUBE in 1 CARTON (68001-483-46) / 14.2 g in 1 TUBE1 tube2021-06-150000-00-00NoNoCurrent