FDA.reportPublic FDA data

TheraCare Triple Antibiotic

Product NDC
71101-018
11-digit product format
711010018
Labeler code
71101
Product ID
71101-018_498b4590-f05f-0d13-e063-6294a90af77f
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc, Neomycin Sulfate, Polymyxin B, and Pramixine HCl
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Veridian Healthcare
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-11-01
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HCL
Active strength
400; 3.5; 5000; 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
TheraCare 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
PRAMOXINE HCL10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii89Y4M234ES, 057Y626693, 19371312D4, 88AYB867L5
Rxcui1999890

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
71101-018-01TheraCare Triple Antibiotic1 in 1 CARTONOINTMENT13
71101-018-01TheraCare Triple Antibiotic28.3 g in 1 TUBEOINTMENT28.33

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1999890bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5,000 UNT / pramoxine HCl 10 MG per GM Topical OintmentPSNd2374664-4668-4da5-9df7-44e6e421ad543
1999890bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical OintmentSCDd2374664-4668-4da5-9df7-44e6e421ad543
1999890bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5,000 UNT / pramoxine hydrochloride 10 MG per GM Topical OintmentSYd2374664-4668-4da5-9df7-44e6e421ad543

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71101-018-01711010018011 TUBE in 1 CARTON (71101-018-01) / 28.3 g in 1 TUBE1 tube2025-11-01NoNoHistorical