FDA.reportPublic FDA data

Publix

Product NDC
41415-049
11-digit product format
414150049
Labeler code
41415
Product ID
41415-049_5aee3a54-1338-4cc0-bef8-10733e4986c7
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin zinc, Neomycin sulfate, and Polymyxin B sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Publix Super Markets Inc
Application
part333B
Marketing category
OTC MONOGRAPH FINAL
Marketing start
1995-12-14
Marketing end
0000-00-00
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400 [iU]/g; mg/g; [iU]/g
NDC exclude flag
No
Listing certified through
2022-12-31
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
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41415-049-752024-01-30C16284748780-19d75b9cf-d880-f424-e053-dadaa90a57cePublix antibioticointment
41415-049-752021-12-15C16284748780-19d75b9cf-d880-f424-e053-dadaa90a57cePublix antibioticointment
41415-049-752020-01-31C16284748780-19d75b9cf-d880-f424-e053-dadaa90a57cePublix antibioticointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41415-049-75Publix antibiotic1 in 1 CARTONOINTMENT12
41415-049-75Publix antibiotic28.4 g in 1 TUBEOINTMENT28.42

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Bacitracin zincACTIVE INGREDIENT89Y4M234ESPUBLIX ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [PUBLIX SUPER MARKETS INC]1
Neomycin sulfateACTIVE INGREDIENT057Y626693PUBLIX ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [PUBLIX SUPER MARKETS INC]1
Polymyxin B sulfateACTIVE INGREDIENT19371312D4PUBLIX ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [PUBLIX SUPER MARKETS INC]1
BacitracinACTIVE MOIETY58H6RWO52IPUBLIX ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [PUBLIX SUPER MARKETS INC]1
NeomycinACTIVE MOIETYI16QD7X297PUBLIX ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [PUBLIX SUPER MARKETS INC]1
Polymyxin BACTIVE MOIETYJ2VZ07J96KPUBLIX ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [PUBLIX SUPER MARKETS INC]1
petrolatumINACTIVE INGREDIENT4T6H12BN9UPUBLIX ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [PUBLIX SUPER MARKETS INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41415-049PUBLIX ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [PUBLIX SUPER MARKETS INC]2Legacy NDC, 2 package rows20211216_c787f5df-eee3-485e-8d43-01ba2113930d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSNc787f5df-eee3-485e-8d43-01ba2113930d2
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCDc787f5df-eee3-485e-8d43-01ba2113930d2
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSYc787f5df-eee3-485e-8d43-01ba2113930d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41415-049-75414150049751 TUBE in 1 CARTON (41415-049-75) > 28.4 g in 1 TUBE1 tube1995-12-140000-00-00NoNoCurrent