FDA.reportPublic FDA data

Double Antibiotic

Product NDC
62011-0097
11-digit product format
620110097
Labeler code
62011
Product ID
62011-0097_39e5bd9b-7cd7-5eba-e063-6394a90aaf43
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc and Polymyxin B Sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Strategic Sourcing Services LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-03-21
Marketing end
2026-06-30
Substance
BACITRACIN ZINC; POLYMYXIN B SULFATE
Active strength
500; 10000 [USP'U]/g; [USP'U]/g
Pharmacologic classes
Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Double Antibiotic

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC500 [USP'U]/g
POLYMYXIN B SULFATE10000 [USP'U]/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii89Y4M234ES, 19371312D4
Rxcui308512

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62011-0097-1Double Antibiotic1 in 1 CARTONOINTMENT17
62011-0097-1Double Antibiotic28.4 g in 1 TUBEOINTMENT28.47

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62011-0097-1GM - Gram62011-0097fd181fd0-cd36-4a36-bf04-fc6f5ee4142712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Bacitracin ZincACTIVE INGREDIENT89Y4M234ESDOUBLE ANTIBIOTIC (BACITRACIN ZINC AND POLYMYXIN B SULFATE) OINTMENT [HEALTH MART]2
Polymyxin B SulfateACTIVE INGREDIENT19371312D4DOUBLE ANTIBIOTIC (BACITRACIN ZINC AND POLYMYXIN B SULFATE) OINTMENT [HEALTH MART]2
BacitracinACTIVE MOIETY58H6RWO52IDOUBLE ANTIBIOTIC (BACITRACIN ZINC AND POLYMYXIN B SULFATE) OINTMENT [HEALTH MART]2
Polymyxin BACTIVE MOIETYJ2VZ07J96KDOUBLE ANTIBIOTIC (BACITRACIN ZINC AND POLYMYXIN B SULFATE) OINTMENT [HEALTH MART]2
petrolatumINACTIVE INGREDIENT4T6H12BN9UDOUBLE ANTIBIOTIC (BACITRACIN ZINC AND POLYMYXIN B SULFATE) OINTMENT [HEALTH MART]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62011-0097DOUBLE ANTIBIOTIC (BACITRACIN ZINC AND POLYMYXIN B SULFATE) OINTMENT [STRATEGIC SOURCING SERVICES LLC]5Current NDC, Legacy NDC, 2 package rows20240123_93aa46b0-0d51-41a6-97da-14393594fb6a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308512bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical OintmentPSN93aa46b0-0d51-41a6-97da-14393594fb6a7
308512bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Topical OintmentSCD93aa46b0-0d51-41a6-97da-14393594fb6a7
308512bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical OintmentSY93aa46b0-0d51-41a6-97da-14393594fb6a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62011-0097-1620110097011 TUBE in 1 CARTON (62011-0097-1) / 28.4 g in 1 TUBE1 tube2012-03-212026-06-30NoNoCurrent