FDA.reportPublic FDA data

Publix

Product NDC
41415-076
11-digit product format
414150076
Labeler code
41415
Product ID
41415-076_39fe9230-350d-06e0-e063-6394a90a2f59
Type
HUMAN OTC DRUG
Nonproprietary name
Neomycin sulfate, Polymyxin B sulfate, and Pramoxine hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Publix Super Markets Inc
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-03-21
Substance
NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Active strength
3.5; 10000; 10 mg/g; [iU]/g; mg/g
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], 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
Publix
Brand name suffix
antibiotic plus Pain Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEOMYCIN SULFATE3.5 mg/g
POLYMYXIN B SULFATE10000 [iU]/g
PRAMOXINE HYDROCHLORIDE10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii057Y626693, 19371312D4, 88AYB867L5
Rxcui1359360

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
41415-076-752024-11-14C16284748780-19d75b9cf-d883-f424-e053-dadaa90a57cePublix antibioticcream plus Pain Relief
41415-076-752024-01-30C16284748780-19d75b9cf-d883-f424-e053-dadaa90a57cePublix antibioticcream plus Pain Relief
41415-076-752021-12-15C16284748780-19d75b9cf-d883-f424-e053-dadaa90a57cePublix antibioticcream plus Pain Relief
41415-076-752020-01-31C16284748780-19d75b9cf-d883-f424-e053-dadaa90a57cePublix antibioticcream plus Pain Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41415-076-75Publixantibiotic plus Pain Relief1 in 1 CARTONCREAM14
41415-076-75Publixantibiotic plus Pain Relief28.4 g in 1 TUBECREAM28.44

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Neomycin sulfateACTIVE INGREDIENT057Y626693PUBLIX ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PUBLIX SUPER MARKETS INC]1
Polymyxin B sulfateACTIVE INGREDIENT19371312D4PUBLIX ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PUBLIX SUPER MARKETS INC]1
Pramoxine hydrochlorideACTIVE INGREDIENT88AYB867L5PUBLIX ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PUBLIX SUPER MARKETS INC]1
NeomycinACTIVE MOIETYI16QD7X297PUBLIX ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PUBLIX SUPER MARKETS INC]1
Polymyxin BACTIVE MOIETYJ2VZ07J96KPUBLIX ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PUBLIX SUPER MARKETS INC]1
PramoxineACTIVE MOIETY068X84E056PUBLIX ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PUBLIX SUPER MARKETS INC]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TPUBLIX ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PUBLIX SUPER MARKETS INC]1
mineral oilINACTIVE INGREDIENTT5L8T28FGPPUBLIX ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PUBLIX SUPER MARKETS INC]1
petrolatumINACTIVE INGREDIENT4T6H12BN9UPUBLIX ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PUBLIX SUPER MARKETS INC]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3PUBLIX ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PUBLIX SUPER MARKETS INC]1
waterINACTIVE INGREDIENT059QF0KO0RPUBLIX ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PUBLIX SUPER MARKETS INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41415-076PUBLIX ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PUBLIX SUPER MARKETS INC]3Current NDC, Legacy NDC, 2 package rows20241116_d0193bf1-a257-490e-a058-5e6a514981da.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 CreamPSNd0193bf1-a257-490e-a058-5e6a514981da4
1359360neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCDd0193bf1-a257-490e-a058-5e6a514981da4
1359360neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10,000 UNT/ML / pramoxine (as pramoxine HCl) 1 % Topical CreamSYd0193bf1-a257-490e-a058-5e6a514981da4
1359360neomycin 0.35 % / polymyxin B 10,000 UNT/ML / pramoxine HCl 1 % Topical CreamSYd0193bf1-a257-490e-a058-5e6a514981da4
1359360neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical CreamSYd0193bf1-a257-490e-a058-5e6a514981da4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41415-076-75414150076751 TUBE in 1 CARTON (41415-076-75) / 28.4 g in 1 TUBE1 tube2012-03-210000-00-00NoNoCurrent