FDA.reportPublic FDA data

equaline

Product NDC
41163-016
11-digit product format
411630016
Labeler code
41163
Product ID
41163-016_f8f88d9d-723a-4c5f-8000-b81745e994f5
Type
HUMAN OTC DRUG
Nonproprietary name
bacitracin zinc, neomycin sulfate, and polymyxin B sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Supervalu 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
2019-12-31
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
41163-016-012020-01-31C16284748780-19d75b9d0-2f0e-f424-e053-dadaa90a57ceequaline™ triple antibiotic
41163-016-022020-01-31C16284748780-19d75b9d0-2f0e-f424-e053-dadaa90a57ceequaline™ triple antibiotic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-016-01equaline triple antibiotic14.2 g in 1 TUBEOINTMENT14.21
41163-016-01equaline triple antibiotic1 in 1 CARTONOINTMENT11
41163-016-02equaline triple antibiotic28.4 g in 1 TUBEOINTMENT28.41
41163-016-02equaline triple antibiotic1 in 1 CARTONOINTMENT11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Bacitracin zincACTIVE INGREDIENT89Y4M234ESEQUALINE TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [SUPERVALU INC]1
Neomycin sulfateACTIVE INGREDIENT057Y626693EQUALINE TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [SUPERVALU INC]1
Polymyxin B sulfateACTIVE INGREDIENT19371312D4EQUALINE TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [SUPERVALU INC]1
BacitracinACTIVE MOIETY58H6RWO52IEQUALINE TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [SUPERVALU INC]1
NeomycinACTIVE MOIETYI16QD7X297EQUALINE TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [SUPERVALU INC]1
Polymyxin BACTIVE MOIETYJ2VZ07J96KEQUALINE TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [SUPERVALU INC]1
petrolatumINACTIVE INGREDIENT4T6H12BN9UEQUALINE TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [SUPERVALU INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-016EQUALINE TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [SUPERVALU INC]1Legacy NDC, 4 package rows20130313_55ba9a6d-9dd9-433a-9221-c1075480e226.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 OintmentPSN55ba9a6d-9dd9-433a-9221-c1075480e2261
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD55ba9a6d-9dd9-433a-9221-c1075480e2261
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY55ba9a6d-9dd9-433a-9221-c1075480e2261

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
41163-016-014116300160114.2 g in 1 TUBE14.2 gHistorical
41163-016-024116300160228.4 g in 1 TUBE28.4 gHistorical