FDA.reportPublic FDA data

Triple Antibiotic

Product NDC
87236-002
11-digit product format
872360002
Labeler code
87236
Product ID
87236-002_516c5621-7dad-8ecb-e063-6394a90a0c26
Type
HUMAN OTC DRUG
Nonproprietary name
First Aid Antibiotic Original Strength
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Aldermed Inc.
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-11-01
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
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 [iU]/g
NEOMYCIN SULFATE3.5 mg/g
POLYMYXIN B SULFATE5000 [iU]/g

Harmonized Identifiers#

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

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
87236-002-01Triple Antibiotic1 in 1 CARTONOINTMENT14
87236-002-01Triple Antibiotic28.4 g in 1 TUBEOINTMENT28.44
87236-002-05Triple Antibiotic0.5 g in 1 PACKETOINTMENT0.54
87236-002-09Triple Antibiotic0.9 g in 1 PACKETOINTMENT0.94
87236-002-14Triple Antibiotic14.2 g in 1 TUBEOINTMENT14.24
87236-002-14Triple Antibiotic1 in 1 CARTONOINTMENT14
87236-002-44Triple Antibiotic144 in 1 CARTONOINTMENT1444
87236-002-44Triple Antibiotic0.9 g in 1 PACKETOINTMENT0.94
87236-002-45Triple Antibiotic0.5 g in 1 PACKETOINTMENT0.54
87236-002-45Triple Antibiotic144 in 1 CARTONOINTMENT1444

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 OintmentPSN19eace87-b505-4be6-93b3-db5323e342164
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD19eace87-b505-4be6-93b3-db5323e342164
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY19eace87-b505-4be6-93b3-db5323e342164

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87236-002-01872360002011 TUBE in 1 CARTON (87236-002-01) / 28.4 g in 1 TUBE1 tube2025-11-01NoNoCurrent
87236-002-0587236000205.5 g in 1 PACKET (87236-002-05) 2025-11-01NoNoCurrent
87236-002-0987236000209.9 g in 1 PACKET (87236-002-09) 2025-11-01NoNoCurrent
87236-002-14872360002141 TUBE in 1 CARTON (87236-002-14) / 14.2 g in 1 TUBE1 tube2025-11-01NoNoCurrent
87236-002-4487236000244144 PACKET in 1 CARTON (87236-002-44) / .9 g in 1 PACKET144 packet2025-11-01NoNoCurrent
87236-002-4587236000245144 PACKET in 1 CARTON (87236-002-45) / .5 g in 1 PACKET144 packet2025-11-01NoNoCurrent