FDA.reportPublic FDA data

Double Antibiotic

Product NDC
58980-012
11-digit product format
589800012
Labeler code
58980
Product ID
58980-012_6c82f396-e1f6-4210-87b1-2615eedbdc6a
Type
HUMAN OTC DRUG
Nonproprietary name
BACITRACIN ZINC and POLYMYXIN B SULFATE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
STRATUS PHARMACEUTICALS INC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-09-15
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
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Double Antibiotic
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
89Y4M234ESInternal UNII lookup
19371312D4Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308512Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f64b3564-ea3c-4316-8f00-f92c08dcad35Available on FDA.report

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
58980-012-01Double Antibiotic144 in 1 BOXOINTMENT1444
58980-012-01Double Antibiotic0.9 g in 1 PACKETOINTMENT0.94
58980-012-05Double Antibiotic14.2 g in 1 TUBEOINTMENT14.24
58980-012-05Double Antibiotic1 in 1 BOXOINTMENT14
58980-012-10Double Antibiotic28.35 g in 1 TUBEOINTMENT28.354
58980-012-10Double Antibiotic1 in 1 BOXOINTMENT14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58980-012-01EA - Each58980-01274ba8db2-0c1b-4268-906c-c36d78ae6d6412020-02-13
58980-012-05GM - Gram58980-012cd555393-3a0f-4bb3-9a1b-3a1c2a476b7312021-03-02
58980-012-10GM - Gram58980-012229bf842-dc27-4c41-8c20-c431dc24b98612026-03-17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58980-012BACITRACIN ZINC (BACITRACIN ZINC AND POLYMYXIN B SULFATE) OINTMENT [STRATUS PHARMACEUTICALS INC]3Current NDC, Legacy NDC, 6 package rows20241107_f64b3564-ea3c-4316-8f00-f92c08dcad35.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 22 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Family Wellness Antiseptic and Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDEFRONT PHARMACEUTICAL PLCcb7fdcde-2bd8-4834-ba4e-4d6fd15125992023-10-26WarningsExact identifier
application number: M004
GENUINE FIRST AID AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.23abfe12-5b50-4b49-878e-4fcdb6c341fd2023-10-19WarningsExact identifier
application number: M004
EVERLIT CARE Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.f4921508-c32f-426f-a2f0-16c3acbd47132023-10-14WarningsExact identifier
application number: M004
CuadridermaBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDEProMex LLC4fa99b96-ab4b-4523-82bc-343dbaf39fb62022-01-25WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308512bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical OintmentPSNf64b3564-ea3c-4316-8f00-f92c08dcad354
308512bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Topical OintmentSCDf64b3564-ea3c-4316-8f00-f92c08dcad354
308512bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical OintmentSYf64b3564-ea3c-4316-8f00-f92c08dcad354

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58980-012-0158980001201144 PACKET in 1 BOX (58980-012-01) / .9 g in 1 PACKET144 packet2017-09-150000-00-00NoNoCurrent
58980-012-05589800012051 TUBE in 1 BOX (58980-012-05) / 14.2 g in 1 TUBE1 tube2021-02-080000-00-00NoNoCurrent
58980-012-10589800012101 TUBE in 1 BOX (58980-012-10) / 28.35 g in 1 TUBE1 tube2026-01-26NoNoCurrent