FDA.reportPublic FDA data

Quality Choice Maximum Strength Triple Antibiotic

Product NDC
63868-009
11-digit product format
638680009
Labeler code
63868
Product ID
63868-009_9a130895-d96a-4fa8-e053-2995a90a4468
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Chain Drug Marketing Association Inc
Application
part333B
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-12-19
Marketing end
0000-00-00
Substance
NEOMYCIN SULFATE; BACITRACIN ZINC; PRAMOXINE HYDROCHLORIDE; POLYMYXIN B SULFATE
Active strength
4 mg/g; [USP'U]/g; mg/g; [USP'U]/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
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
63868-009-282020-09-27C16284748780-1ab0e2407-2f30-f274-e053-dbdaa90a6471QC Max Strength Triple Antibiotic Ointment 1 oz. 94594 CMI 2019
63868-009-282020-09-25C16284748780-1ab0e2407-2f30-f274-e053-dbdaa90a6471QC Max Strength Triple Antibiotic Ointment 1 oz. 94594 CMI 2019
63868-009-282020-07-22C16284748780-1ab0e2407-2f30-f274-e053-dbdaa90a6471QC Max Strength Triple Antibiotic Ointment 1 oz. 94594 CMI 2019

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-009-28Quality Choice Maximum Strength Triple Antibiotic28 g in 1 TUBEOINTMENT281
63868-009-28Quality Choice Maximum Strength Triple Antibiotic1 in 1 CARTONOINTMENT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-009QUALITY CHOICE MAXIMUM STRENGTH TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]1Legacy NDC, 2 package rows20191221_9a130895-d969-4fa8-e053-2995a90a4468.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG in GM Topical OintmentPSN9a130895-d969-4fa8-e053-2995a90a44681
1359350bacitracin 0.5 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical OintmentSCD9a130895-d969-4fa8-e053-2995a90a44681
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical OintmentSY9a130895-d969-4fa8-e053-2995a90a44681

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
63868-009-286386800092828 g in 1 TUBE28 gHistorical