FDA.reportPublic FDA data

Double Antibiotic

Product NDC
70677-1212
11-digit product format
706771212
Labeler code
70677
Product ID
70677-1212_39e54532-21d5-61e3-e063-6294a90a632b
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
2023-12-15
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
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Double Antibiotic
Listing expiration
2026-12-31

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
70677-1212-1Double Antibiotic28.4 g in 1 TUBEOINTMENT28.42
70677-1212-1Double Antibiotic1 in 1 CARTONOINTMENT12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1212-1GM - Gram70677-1212bd185fda-39e0-4d4b-8e9c-3e3151a8b9e312024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1212DOUBLE ANTIBIOTIC (BACITRACIN ZINC AND POLYMYXIN B SULFATE) OINTMENT [STRATEGIC SOURCING SERVICES LLC]1Current NDC, 2 package rows20240103_38414fff-8dad-44d0-9dfa-f89a63ef9b44.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308512bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical OintmentPSN38414fff-8dad-44d0-9dfa-f89a63ef9b442
308512bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Topical OintmentSCD38414fff-8dad-44d0-9dfa-f89a63ef9b442
308512bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical OintmentSY38414fff-8dad-44d0-9dfa-f89a63ef9b442

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70677-1212-1706771212011 TUBE in 1 CARTON (70677-1212-1) / 28.4 g in 1 TUBE1 tube2023-12-15NoNoHistorical