FDA.reportPublic FDA data

sunmark

Product NDC
49348-029
11-digit product format
493480029
Labeler code
49348
Product ID
49348-029_45df6359-262f-442a-bdd5-c7d62d43a449
Type
HUMAN OTC DRUG
Nonproprietary name
polymyxin B sulfate, bacitracin zinc, and neomycin sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
McKesson
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
49348-029-722020-01-31C16284748780-19d75b9d1-0bf7-f424-e053-dadaa90a57cesunmark ™ triple antibiotic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49348-029-72sunmark triple antibiotic1 in 1 CARTONOINTMENT12
49348-029-72sunmark triple antibiotic28.4 g in 1 TUBEOINTMENT28.42

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-029-72GM - Gram49348-02944f14919-6978-4bfe-ae54-7d16b257f1dc12013-02-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
bacitracin zincACTIVE INGREDIENT89Y4M234ESSUNMARK TRIPLE ANTIBIOTIC (POLYMYXIN B SULFATE, BACITRACIN ZINC, AND NEOMYCIN SULFATE) OINTMENT [MCKESSON]2
neomycin sulfateACTIVE INGREDIENT057Y626693SUNMARK TRIPLE ANTIBIOTIC (POLYMYXIN B SULFATE, BACITRACIN ZINC, AND NEOMYCIN SULFATE) OINTMENT [MCKESSON]2
polymyxin B sulfateACTIVE INGREDIENT19371312D4SUNMARK TRIPLE ANTIBIOTIC (POLYMYXIN B SULFATE, BACITRACIN ZINC, AND NEOMYCIN SULFATE) OINTMENT [MCKESSON]2
BacitracinACTIVE MOIETY58H6RWO52ISUNMARK TRIPLE ANTIBIOTIC (POLYMYXIN B SULFATE, BACITRACIN ZINC, AND NEOMYCIN SULFATE) OINTMENT [MCKESSON]2
NeomycinACTIVE MOIETYI16QD7X297SUNMARK TRIPLE ANTIBIOTIC (POLYMYXIN B SULFATE, BACITRACIN ZINC, AND NEOMYCIN SULFATE) OINTMENT [MCKESSON]2
Polymyxin BACTIVE MOIETYJ2VZ07J96KSUNMARK TRIPLE ANTIBIOTIC (POLYMYXIN B SULFATE, BACITRACIN ZINC, AND NEOMYCIN SULFATE) OINTMENT [MCKESSON]2
petrolatumINACTIVE INGREDIENT4T6H12BN9USUNMARK TRIPLE ANTIBIOTIC (POLYMYXIN B SULFATE, BACITRACIN ZINC, AND NEOMYCIN SULFATE) OINTMENT [MCKESSON]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-029SUNMARK TRIPLE ANTIBIOTIC (POLYMYXIN B SULFATE, BACITRACIN ZINC, AND NEOMYCIN SULFATE) OINTMENT [MCKESSON]2Legacy NDC, 2 package rows20130417_c07d4042-c5f0-4abc-8d5f-76893eec1fc8.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 OintmentPSNc07d4042-c5f0-4abc-8d5f-76893eec1fc82
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCDc07d4042-c5f0-4abc-8d5f-76893eec1fc82
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSYc07d4042-c5f0-4abc-8d5f-76893eec1fc82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
49348-029-72493480029721 in 1 CARTONHistorical