FDA.reportPublic FDA data

Triple Antibiotic plus pain relief

Product NDC
30142-679
11-digit product format
301420679
Labeler code
30142
Product ID
30142-679_64ed7cef-be19-41a4-a541-ebf298316d8c
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin, Neomycin, Polymyxin B, Pramoxine HCl
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Kroger Company
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-04-27
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Active strength
500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC500 [USP'U]/g
NEOMYCIN SULFATE3.5 mg/g
POLYMYXIN B SULFATE10000 [USP'U]/g
PRAMOXINE HYDROCHLORIDE10 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
30142-679-64Triple Antibiotic plus pain relief1 in 1 CARTONOINTMENT13
30142-679-64Triple Antibiotic plus pain relief28 g in 1 TUBEOINTMENT283

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-679TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) OINTMENT [KROGER COMPANY]3Current NDC, Legacy NDC, 2 package rows20241008_e31c8d92-bf9f-4b7f-8f81-54199745cd20.zip

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 OintmentPSNe31c8d92-bf9f-4b7f-8f81-54199745cd203
1359350bacitracin 0.5 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical OintmentSCDe31c8d92-bf9f-4b7f-8f81-54199745cd203
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical OintmentSYe31c8d92-bf9f-4b7f-8f81-54199745cd203

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-679-64301420679641 TUBE in 1 CARTON (30142-679-64) / 28 g in 1 TUBE1 tube2017-04-270000-00-00NoNoCurrent