FDA.reportPublic FDA data

ANTIBIOTIC PLUS PAIN RELIEF

Product NDC
52426-220
11-digit product format
524260220
Labeler code
52426
Product ID
52426-220_ad7a427d-3ad0-4a47-8e2f-223b9242bd90
Type
HUMAN OTC DRUG
Nonproprietary name
Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Phoenix Global Supply Group, Inc.
Application
part333B
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-07-01
Marketing end
0000-00-00
Substance
NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Active strength
4 mg/g; [iU]/g; mg/g
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52426-220-042020-01-31C16284748780-19d75b9cf-da66-f424-e053-dadaa90a57ceMYXCIN™-AB
52426-220-052020-01-31C16284748780-19d75b9d0-70b4-f424-e053-dadaa90a57ceAntibiotic Cream + Pain Relief
52426-220-062020-01-31C16284748780-19d75b9d0-70b4-f424-e053-dadaa90a57ceAntibiotic Cream + Pain Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52426-220-04ANTIBIOTIC PLUS PAIN RELIEF10 g in 1 BOTTLE, PUMPCREAM101
52426-220-04ANTIBIOTIC PLUS PAIN RELIEF1 in 1 BLISTER PACKCREAM11
52426-220-05Antibiotic Plus Pain Relief1 in 1 CARTONCREAM11
52426-220-05Antibiotic Plus Pain Relief14.2 g in 1 TUBECREAM14.21
52426-220-06Antibiotic Plus Pain Relief28.4 g in 1 TUBECREAM28.41
52426-220-06Antibiotic Plus Pain Relief1 in 1 CARTONCREAM11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Neomycin SulfateACTIVE INGREDIENT057Y626693ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PHOENIX GLOBAL SUPPLY GROUP, INC.]1
Neomycin SulfateACTIVE INGREDIENT057Y626693ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PHOENIX GLOBAL SUPPLY GROUP, INC.]1
Polymyxin B SulfateACTIVE INGREDIENT19371312D4ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PHOENIX GLOBAL SUPPLY GROUP, INC.]1
Polymyxin B SulfateACTIVE INGREDIENT19371312D4ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PHOENIX GLOBAL SUPPLY GROUP, INC.]1
Pramoxine HydrochlorideACTIVE INGREDIENT88AYB867L5ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PHOENIX GLOBAL SUPPLY GROUP, INC.]1
Pramoxine HydrochlorideACTIVE INGREDIENT88AYB867L5ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PHOENIX GLOBAL SUPPLY GROUP, INC.]1
NeomycinACTIVE MOIETYI16QD7X297ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PHOENIX GLOBAL SUPPLY GROUP, INC.]1
NeomycinACTIVE MOIETYI16QD7X297ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PHOENIX GLOBAL SUPPLY GROUP, INC.]1
Polymyxin BACTIVE MOIETYJ2VZ07J96KANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PHOENIX GLOBAL SUPPLY GROUP, INC.]1
Polymyxin BACTIVE MOIETYJ2VZ07J96KANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PHOENIX GLOBAL SUPPLY GROUP, INC.]1
PramoxineACTIVE MOIETY068X84E056ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PHOENIX GLOBAL SUPPLY GROUP, INC.]1
PramoxineACTIVE MOIETY068X84E056ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PHOENIX GLOBAL SUPPLY GROUP, INC.]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PHOENIX GLOBAL SUPPLY GROUP, INC.]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PHOENIX GLOBAL SUPPLY GROUP, INC.]1
mineral oilINACTIVE INGREDIENTT5L8T28FGPANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PHOENIX GLOBAL SUPPLY GROUP, INC.]1
mineral oilINACTIVE INGREDIENTT5L8T28FGPANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PHOENIX GLOBAL SUPPLY GROUP, INC.]1
petrolatumINACTIVE INGREDIENT4T6H12BN9UANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PHOENIX GLOBAL SUPPLY GROUP, INC.]1
petrolatumINACTIVE INGREDIENT4T6H12BN9UANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PHOENIX GLOBAL SUPPLY GROUP, INC.]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PHOENIX GLOBAL SUPPLY GROUP, INC.]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PHOENIX GLOBAL SUPPLY GROUP, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PHOENIX GLOBAL SUPPLY GROUP, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PHOENIX GLOBAL SUPPLY GROUP, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52426-220ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PHOENIX GLOBAL SUPPLY GROUP, INC.]1Legacy NDC, 4 package rows20101014_25668cbf-b3b6-4825-9aeb-be0bb7d776d1.zip
52426-220ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PHOENIX GLOBAL SUPPLY GROUP, INC.]1Legacy NDC, 2 package rows20110701_15d6a038-7f8d-4f89-96f9-06c4deb2b0a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1359360neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical CreamPSN15d6a038-7f8d-4f89-96f9-06c4deb2b0a11
1359360neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical CreamPSN25668cbf-b3b6-4825-9aeb-be0bb7d776d11
1359360neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCD15d6a038-7f8d-4f89-96f9-06c4deb2b0a11
1359360neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCD25668cbf-b3b6-4825-9aeb-be0bb7d776d11
1359360neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10,000 UNT/ML / pramoxine (as pramoxine HCl) 1 % Topical CreamSY15d6a038-7f8d-4f89-96f9-06c4deb2b0a11
1359360neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10,000 UNT/ML / pramoxine (as pramoxine HCl) 1 % Topical CreamSY25668cbf-b3b6-4825-9aeb-be0bb7d776d11
1359360neomycin 0.35 % / polymyxin B 10,000 UNT/ML / pramoxine HCl 1 % Topical CreamSY15d6a038-7f8d-4f89-96f9-06c4deb2b0a11
1359360neomycin 0.35 % / polymyxin B 10,000 UNT/ML / pramoxine HCl 1 % Topical CreamSY25668cbf-b3b6-4825-9aeb-be0bb7d776d11
1359360neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical CreamSY15d6a038-7f8d-4f89-96f9-06c4deb2b0a11
1359360neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical CreamSY25668cbf-b3b6-4825-9aeb-be0bb7d776d11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
52426-220-045242602200410 g in 1 BOTTLE, PUMP10 gHistorical
52426-220-05524260220051 in 1 CARTONHistorical
52426-220-065242602200628.4 g in 1 TUBE28.4 gHistorical