FDA.reportPublic FDA data

Triple Antibiotic

Product NDC
87236-016
11-digit product format
872360016
Labeler code
87236
Product ID
87236-016_516c33cb-9958-b0dc-e063-6394a90acdca
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Pramoxine HCl
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Aldermed Inc.
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-01
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HCL
Active strength
500; 3.5; 10000; 10 [iU]/g; mg/g; [iU]/g; mg/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
Brand name suffix
First Aid Antibiotic plus Pain Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC500 [iU]/g
NEOMYCIN SULFATE3.5 mg/g
POLYMYXIN B SULFATE10000 [iU]/g
PRAMOXINE HCL10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii89Y4M234ES, 057Y626693, 19371312D4, 88AYB867L5
Rxcui1359350

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
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87236-016-01Triple AntibioticFirst Aid Antibiotic plus Pain Relief28.4 g in 1 TUBEOINTMENT28.43
87236-016-01Triple AntibioticFirst Aid Antibiotic plus Pain Relief1 in 1 CARTONOINTMENT13
87236-016-14Triple AntibioticFirst Aid Antibiotic plus Pain Relief14.2 g in 1 TUBEOINTMENT14.23
87236-016-14Triple AntibioticFirst Aid Antibiotic plus Pain Relief1 in 1 CARTONOINTMENT13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG in GM Topical OintmentPSN5bfc7776-1030-48ba-9df4-897c4984c9e63
1359350bacitracin 0.5 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical OintmentSCD5bfc7776-1030-48ba-9df4-897c4984c9e63
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical OintmentSY5bfc7776-1030-48ba-9df4-897c4984c9e63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87236-016-01872360016011 TUBE in 1 CARTON (87236-016-01) / 28.4 g in 1 TUBE1 tube2025-12-01NoNoHistorical
87236-016-14872360016141 TUBE in 1 CARTON (87236-016-14) / 14.2 g in 1 TUBE1 tube2025-12-01NoNoHistorical