FDA.reportPublic FDA data

Aftate Triple Antibiotic

Product NDC
70356-101
11-digit product format
703560101
Labeler code
70356
Product ID
70356-101_2f6e9a84-895d-492d-e054-00144ff8d46c
Type
HUMAN OTC DRUG
Nonproprietary name
Triple Antibiotic Ointment
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Sabel Med LLC
Application
part333B
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-05-01
Marketing end
0000-00-00
Substance
POLYMYXIN B SULFATE; NEOMYCIN SULFATE; BACITRACIN ZINC
Active strength
5000 [iU]/g; mg/g; [iU]/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
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
70356-101-012020-01-31C16284748780-19d75b9d0-ceb9-f424-e053-dadaa90a57ceTriple Antibiotic Ointment
70356-101-052020-01-31C16284748780-19d75b9d0-ceb9-f424-e053-dadaa90a57ceTriple Antibiotic Ointment
70356-101-332020-01-31C16284748780-19d75b9d0-ceb9-f424-e053-dadaa90a57ceTriple Antibiotic Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70356-101-01Aftate Triple Antibiotic28 g in 1 TUBEOINTMENT281
70356-101-05Aftate Triple Antibiotic14 g in 1 TUBEOINTMENT141
70356-101-33Aftate Triple Antibiotic9.4 g in 1 TUBEOINTMENT9.41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70356-101AFTATE TRIPLE ANTIBIOTIC (TRIPLE ANTIBIOTIC OINTMENT) OINTMENT [SABEL MED LLC]1Legacy NDC, 3 package rows20160501_2f6e9a84-895c-492d-e054-00144ff8d46c.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 OintmentPSN2f6e9a84-895c-492d-e054-00144ff8d46c1
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD2f6e9a84-895c-492d-e054-00144ff8d46c1
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY2f6e9a84-895c-492d-e054-00144ff8d46c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
70356-101-017035601010128 g in 1 TUBE28 gHistorical
70356-101-057035601010514 g in 1 TUBE14 gHistorical
70356-101-33703560101339.4 g in 1 TUBE9.4 gHistorical