FDA.reportPublic FDA data

First Aid Antibiotic Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate

Product NDC
84219-001
11-digit product format
842190001
Labeler code
84219
Product ID
84219-001_15081208-e9bb-be2f-e063-6394a90a5bc6
Type
HUMAN OTC DRUG
Nonproprietary name
BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE
Dosage form
GEL
Route
TOPICAL
Labeler
M-star (Hubei) Health&Care Products Co., Ltd.
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-15
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400; 3.5; 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 Antibiotic Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

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

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
84219-001-00First Aid Antibiotic Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate0.5 g in 1 POUCHGEL0.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84219-001FIRST AID ANTIBIOTIC BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) GEL [M-STAR (HUBEI) HEALTH&CARE PRODUCTS CO., LTD.]1Current NDC, 1 package rows20240515_c6f2656e-b822-4d61-b557-dd2046dd51f5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
84219-001-0084219000100.5 g in 1 POUCH (84219-001-00) 2024-05-15NoNoHistorical