FDA.reportPublic FDA data

CAREONE

Product NDC
41520-016
11-digit product format
415200016
Labeler code
41520
Product ID
41520-016_7e943bcb-5e84-45eb-bcc7-d6b75afeea79
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
American Sales Company
Application
part333B
Marketing category
OTC MONOGRAPH FINAL
Marketing start
1995-12-14
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
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
41520-016-012020-01-31C16284748780-19d75b9cf-d8bc-f424-e053-dadaa90a57ceCAREONE™ Triple Antibiotic Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-016-01CAREONE Triple Antibiotic1 in 1 CARTONOINTMENT12
41520-016-01CAREONE Triple Antibiotic14.2 g in 1 TUBEOINTMENT14.22

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Bacitracin ZincACTIVE INGREDIENT89Y4M234ESCAREONE TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [AMERICAN SALES COMPANY]2
Neomycin SulfateACTIVE INGREDIENT057Y626693CAREONE TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [AMERICAN SALES COMPANY]2
Polymyxin B SulfateACTIVE INGREDIENT19371312D4CAREONE TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [AMERICAN SALES COMPANY]2
BacitracinACTIVE MOIETY58H6RWO52ICAREONE TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [AMERICAN SALES COMPANY]2
NeomycinACTIVE MOIETYI16QD7X297CAREONE TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [AMERICAN SALES COMPANY]2
Polymyxin BACTIVE MOIETYJ2VZ07J96KCAREONE TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [AMERICAN SALES COMPANY]2
petrolatumINACTIVE INGREDIENT4T6H12BN9UCAREONE TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [AMERICAN SALES COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-016CAREONE TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [AMERICAN SALES COMPANY]2Legacy NDC, 2 package rows20130417_3534a7a1-f3cc-467e-b18e-1d37b3acce1f.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 OintmentPSN3534a7a1-f3cc-467e-b18e-1d37b3acce1f2
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD3534a7a1-f3cc-467e-b18e-1d37b3acce1f2
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY3534a7a1-f3cc-467e-b18e-1d37b3acce1f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
41520-016-01415200016011 in 1 CARTONHistorical