FDA.reportPublic FDA data

First Aid Only Neomycin Antibiotic

Product NDC
0924-5620
11-digit product format
009245620
Labeler code
0924
Product ID
0924-5620_274a854a-cbfe-ffa1-e063-6294a90a1ea2
Type
HUMAN OTC DRUG
Nonproprietary name
neomycin sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Acme United Corporation
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-07-16
Substance
NEOMYCIN SULFATE
Active strength
3.5 mg/g
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [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 Neomycin Antibiotic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEOMYCIN SULFATE3.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii057Y626693
Rxcui311928

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0924-5620-00First Aid Only Neomycin Antibiotic0.9 g in 1 POUCHOINTMENT0.93
0924-5620-01First Aid Only Neomycin Antibiotic10 in 1 BOXOINTMENT103
0924-5620-01First Aid Only Neomycin Antibiotic0.9 g in 1 POUCHOINTMENT0.93
0924-5620-02First Aid Only Neomycin Antibiotic0.9 g in 1 POUCHOINTMENT0.93
0924-5620-02First Aid Only Neomycin Antibiotic20 in 1 BOXOINTMENT203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0924-5620FIRST AID ONLY NEOMYCIN ANTIBIOTIC (NEOMYCIN SULFATE) OINTMENT [ACME UNITED CORPORATION]3Current NDC, Legacy NDC, 5 package rows20241121_c651e98e-aabe-de46-e053-2a95a90a6307.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311928neomycin 0.35 % Topical OintmentPSNc651e98e-aabe-de46-e053-2a95a90a63073
311928neomycin 0.0035 MG/MG Topical OintmentSCDc651e98e-aabe-de46-e053-2a95a90a63073
311928neomycin (as neomycin sulfate 5 MG per 1 GM) 3.5 MG per 1 GM Topical OintmentSYc651e98e-aabe-de46-e053-2a95a90a63073
311928neomycin 0.35 % Topical OintmentSYc651e98e-aabe-de46-e053-2a95a90a63073

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0924-5620-0000924562000.9 g in 1 POUCH (0924-5620-00) 2021-07-160000-00-00NoNoCurrent
0924-5620-010092456200110 POUCH in 1 BOX (0924-5620-01) / .9 g in 1 POUCH10 pouch2023-05-10NoNoCurrent
0924-5620-020092456200220 POUCH in 1 BOX (0924-5620-02) / .9 g in 1 POUCH20 pouch2023-05-10NoNoCurrent