FDA.reportPublic FDA data

careone triple antibiotic

Product NDC
41520-067
11-digit product format
415200067
Labeler code
41520
Product ID
41520-067_412fbcf7-fe57-4d68-98f5-55887274ca67
Type
HUMAN OTC DRUG
Nonproprietary name
bacitracin zinc, neomycin sulfate, polymyxin B sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
American Sales Company
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-10-01
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], 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
careone triple antibiotic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC400 [USP'U]/g
NEOMYCIN SULFATE3.5 mg/g
POLYMYXIN B SULFATE5000 [USP'U]/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii89Y4M234ES, 057Y626693, 19371312D4
Rxcui204602

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-067-58careone triple antibiotic1 in 1 CARTONOINTMENT15
41520-067-58careone triple antibiotic14 g in 1 TUBEOINTMENT145
41520-067-64careone triple antibiotic1 in 1 CARTONOINTMENT15
41520-067-64careone triple antibiotic28 g in 1 TUBEOINTMENT285

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-067CAREONE TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [AMERICAN SALES COMPANY]5Current NDC, Legacy NDC, 4 package rows20240921_09a0b0b9-1806-4ff9-80fa-448dabbf2cc7.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 OintmentPSN09a0b0b9-1806-4ff9-80fa-448dabbf2cc75
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD09a0b0b9-1806-4ff9-80fa-448dabbf2cc75
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY09a0b0b9-1806-4ff9-80fa-448dabbf2cc75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-067-28415200067281 TUBE in 1 CARTON (41520-067-28) > 14 g in 1 TUBE1 tube2021-02-240000-00-00NoNoCurrent
41520-067-58415200067581 TUBE in 1 CARTON (41520-067-58) / 14 g in 1 TUBE1 tube2021-02-24NoNoCurrent
41520-067-64415200067641 TUBE in 1 CARTON (41520-067-64) / 28 g in 1 TUBE1 tube2019-10-010000-00-00NoNoCurrent