FDA.reportPublic FDA data

First Aid Only Triple Antibiotic

Product NDC
0924-5618
11-digit product format
009245618
Labeler code
0924
Product ID
0924-5618_2749912f-9bf8-7cf9-e063-6394a90a5a94
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
2023-02-24
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400; 5; 5000 U/g; mg/g; 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
First Aid Only Triple Antibiotic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC400 U/g
NEOMYCIN SULFATE5 mg/g
POLYMYXIN B SULFATE5000 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
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
0924-5618-00First Aid Only Triple Antibiotic0.5 g in 1 POUCHOINTMENT0.53
0924-5618-02First Aid Only Triple Antibiotic0.5 g in 1 POUCHOINTMENT0.53
0924-5618-02First Aid Only Triple Antibiotic12 in 1 BOXOINTMENT123
0924-5618-03First Aid Only Triple Antibiotic25 in 1 BOXOINTMENT253
0924-5618-03First Aid Only Triple Antibiotic0.5 g in 1 POUCHOINTMENT0.53
0924-5618-04First Aid Only Triple Antibiotic60 in 1 BOXOINTMENT603
0924-5618-04First Aid Only Triple Antibiotic0.5 g in 1 POUCHOINTMENT0.53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0924-5618FIRST AID ONLY TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [ACME UNITED CORPORATION]3Current NDC, 7 package rows20241121_f4eba34c-ce31-3004-e053-2995a90a245b.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 OintmentPSNf4eba34c-ce31-3004-e053-2995a90a245b3
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCDf4eba34c-ce31-3004-e053-2995a90a245b3
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSYf4eba34c-ce31-3004-e053-2995a90a245b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0924-5618-0000924561800.5 g in 1 POUCH (0924-5618-00) 2023-02-24NoNoCurrent
0924-5618-020092456180212 POUCH in 1 BOX (0924-5618-02) / .5 g in 1 POUCH12 pouch2023-06-12NoNoCurrent
0924-5618-030092456180325 POUCH in 1 BOX (0924-5618-03) / .5 g in 1 POUCH25 pouch2023-06-12NoNoCurrent
0924-5618-040092456180460 POUCH in 1 BOX (0924-5618-04) / .5 g in 1 POUCH60 pouch2023-02-24NoNoCurrent