FDA.reportPublic FDA data

Triple Antibiotic

Product NDC
49035-120
11-digit product format
490350120
Labeler code
49035
Product ID
49035-120_8901a21d-1963-4d31-a42f-caa47cdc6d48
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Wal-Mart Stores, Inc.
Application
part333B
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-12-15
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
2020-12-31
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
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
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
49035-120-022021-01-29C16284748780-1ba0f9c33-4b3e-a910-e053-dadaa90a0b85Triple Antibiotic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-120-02Triple Antibiotic28.4 g in 1 TUBEOINTMENT28.42
49035-120-02Triple Antibiotic1 in 1 CARTONOINTMENT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-120TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [WAL-MART STORES, INC.]2Legacy NDC, 2 package rows20170718_913d8b97-64e7-4bc0-9994-d84e91ab3a1d.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 OintmentPSN913d8b97-64e7-4bc0-9994-d84e91ab3a1d2
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD913d8b97-64e7-4bc0-9994-d84e91ab3a1d2
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY913d8b97-64e7-4bc0-9994-d84e91ab3a1d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
49035-120-024903501200228.4 g in 1 TUBE28.4 gHistorical