FDA.reportPublic FDA data

OLP Triple Antibiotic Plus

Product NDC
70648-121
11-digit product format
706480121
Labeler code
70648
Product ID
70648-121_7b9bdd3c-6222-0b7e-e053-2a91aa0ab0e2
Type
HUMAN OTC DRUG
Nonproprietary name
bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Ohio Lab Pharma
Application
part333B
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2017-12-06
Marketing end
0000-00-00
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Active strength
400 [USP'U]/g; mg/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
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70648-121-012020-01-31C16284748780-19d75b9cf-f8d8-f424-e053-dadaa90a57ce5fb447d6-dbbf-6745-e053-2a91aa0ae0bf

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70648-121-01OLP Triple Antibiotic Plus9.4 g in 1 TUBEOINTMENT9.43
70648-121-01OLP Triple Antibiotic Plus1 in 1 CARTONOINTMENT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70648-121OLP TRIPLE ANTIBIOTIC PLUS (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE) OINTMENT [OHIO LAB PHARMA]3Legacy NDC, 2 package rows20181127_5fb447d6-dbbf-6745-e053-2a91aa0ae0bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1999890bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5,000 UNT / pramoxine HCl 10 MG per GM Topical OintmentPSN5fb447d6-dbbf-6745-e053-2a91aa0ae0bf3
1999890bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical OintmentSCD5fb447d6-dbbf-6745-e053-2a91aa0ae0bf3
1999890bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5,000 UNT / pramoxine hydrochloride 10 MG per GM Topical OintmentSY5fb447d6-dbbf-6745-e053-2a91aa0ae0bf3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
70648-121-01706480121019.4 g in 1 TUBE9.4 gHistorical