FDA.reportPublic FDA data

OLP Triple Antibiotic

Product NDC
70648-555
11-digit product format
706480555
Labeler code
70648
Product ID
70648-555_7b9c7b3e-3cd8-9323-e053-2a91aa0a13da
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin zinc, polymyxin B sulfate, neomycin sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Ohio Lab Pharma
Application
part333B
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2017-10-18
Marketing end
0000-00-00
Substance
BACITRACIN ZINC; POLYMYXIN B SULFATE; NEOMYCIN SULFATE
Active strength
400 [USP'U]/g; [USP'U]/g; mg/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
70648-555-012020-01-31C16284748780-19d75b9d1-00cc-f424-e053-dadaa90a57ce5bd568c4-3f52-07a2-e053-2991aa0a10db

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70648-555-01OLP Triple Antibiotic9.4 g in 1 TUBEOINTMENT9.42
70648-555-01OLP Triple Antibiotic1 in 1 CARTONOINTMENT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70648-555OLP TRIPLE ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE) OINTMENT [OHIO LAB PHARMA]2Legacy NDC, 2 package rows20181127_5bd568c4-3f52-07a2-e053-2991aa0a10db.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 OintmentPSN5bd568c4-3f52-07a2-e053-2991aa0a10db2
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD5bd568c4-3f52-07a2-e053-2991aa0a10db2
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY5bd568c4-3f52-07a2-e053-2991aa0a10db2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
70648-555-01706480555019.4 g in 1 TUBE9.4 gHistorical