FDA.reportPublic FDA data

triple antibiotic pain relief

Product NDC
0363-6790
11-digit product format
003636790
Labeler code
0363
Product ID
0363-6790_6d975a99-4c09-412b-a9ae-59962e3d4d94
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin, Neomycin, Polymyxin B, Pramoxine HCl
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Walgreen Company
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-07
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 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
0363-6790-58triple antibiotic pain relief14 g in 1 TUBEOINTMENT143
0363-6790-58triple antibiotic pain relief1 in 1 CARTONOINTMENT13
0363-6790-64triple antibiotic pain relief1 in 1 CARTONOINTMENT13
0363-6790-64triple antibiotic pain relief28 g in 1 TUBEOINTMENT283

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-6790TRIPLE ANTIBIOTIC PAIN RELIEF (BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) OINTMENT [WALGREEN COMPANY]3Current NDC, 4 package rows20241008_f0fa2822-02a2-49e5-ad47-aa7e9cc2da71.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 OintmentPSNf0fa2822-02a2-49e5-ad47-aa7e9cc2da713
1359350bacitracin 0.5 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical OintmentSCDf0fa2822-02a2-49e5-ad47-aa7e9cc2da713
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical OintmentSYf0fa2822-02a2-49e5-ad47-aa7e9cc2da713

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-6790-58003636790581 TUBE in 1 CARTON (0363-6790-58) / 14 g in 1 TUBE1 tube2024-03-13NoNoHistorical
0363-6790-64003636790641 TUBE in 1 CARTON (0363-6790-64) / 28 g in 1 TUBE1 tube2024-03-07NoNoHistorical