FDA.reportPublic FDA data

Triple Antibiotic

Product NDC
0924-5604
11-digit product format
009245604
Labeler code
0924
Product ID
0924-5604_27495546-006d-ad90-e063-6394a90a71ce
Type
HUMAN OTC DRUG
Nonproprietary name
bacitracin zinc, neomycin sulfate, polymyxin b sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Acme United Corporation
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-04-24
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400; 3.5; 5000 [iU]/g; mg/g; [iU]/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
Triple Antibiotic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC400 [iU]/g
NEOMYCIN SULFATE3.5 mg/g
POLYMYXIN B SULFATE5000 [iU]/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
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
0924-5604-00Triple Antibiotic0.5 g in 1 POUCHOINTMENT0.52
0924-5604-01Triple Antibiotic0.5 g in 1 POUCHOINTMENT0.52
0924-5604-01Triple Antibiotic6 in 1 BAGOINTMENT62
0924-5604-02Triple Antibiotic0.5 g in 1 PACKETOINTMENT0.52
0924-5604-02Triple Antibiotic10 in 1 BOXOINTMENT102
0924-5604-03Triple Antibiotic12 in 1 BOXOINTMENT122
0924-5604-03Triple Antibiotic0.5 g in 1 POUCHOINTMENT0.52
0924-5604-04Triple Antibiotic0.5 g in 1 PACKETOINTMENT0.52
0924-5604-04Triple Antibiotic20 in 1 BOXOINTMENT202
0924-5604-05Triple Antibiotic0.5 g in 1 PACKETOINTMENT0.52
0924-5604-05Triple Antibiotic25 in 1 BOXOINTMENT252
0924-5604-06Triple Antibiotic60 in 1 BOXOINTMENT602
0924-5604-06Triple Antibiotic0.5 g in 1 PACKETOINTMENT0.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0924-5604TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [ACME UNITED CORPORATION]2Current NDC, 13 package rows20241121_f9a48f73-aa12-cf68-e053-6294a90a8e53.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 OintmentPSNf9a48f73-aa12-cf68-e053-6294a90a8e532
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCDf9a48f73-aa12-cf68-e053-6294a90a8e532
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSYf9a48f73-aa12-cf68-e053-6294a90a8e532

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0924-5604-0000924560400.5 g in 1 POUCH (0924-5604-00) 2023-04-24NoNoCurrent
0924-5604-01009245604016 POUCH in 1 BAG (0924-5604-01) / .5 g in 1 POUCH6 pouch2023-04-24NoNoCurrent
0924-5604-020092456040210 PACKET in 1 BOX (0924-5604-02) / .5 g in 1 PACKET10 packet2023-04-24NoNoCurrent
0924-5604-030092456040312 POUCH in 1 BOX (0924-5604-03) / .5 g in 1 POUCH12 pouch2023-04-24NoNoCurrent
0924-5604-040092456040420 PACKET in 1 BOX (0924-5604-04) / .5 g in 1 PACKET20 packet2023-04-24NoNoCurrent
0924-5604-050092456040525 PACKET in 1 BOX (0924-5604-05) / .5 g in 1 PACKET25 packet2023-04-24NoNoCurrent
0924-5604-060092456040660 PACKET in 1 BOX (0924-5604-06) / .5 g in 1 PACKET60 packet2023-04-24NoNoCurrent