FDA.reportPublic FDA data

Genuine First Aid First Aid Antibiotic Bacitracin Zinc

Product NDC
50814-058
11-digit product format
508140058
Labeler code
50814
Product ID
50814-058_247ecba5-1967-0179-e063-6394a90a0371
Type
HUMAN OTC DRUG
Nonproprietary name
BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE
Dosage form
CREAM
Route
TOPICAL
Labeler
GFA Production (Xiamen) Co., Ltd.
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-01
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
Genuine First Aid First Aid Antibiotic Bacitracin Zinc
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
Rxcui283616

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
50814-058-01Genuine First Aid First Aid Antibiotic Bacitracin Zinc0.9 g in 1 PACKAGECREAM0.93

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50814-058GENUINE FIRST AID FIRST AID ANTIBIOTIC BACITRACIN ZINC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) CREAM [GFA PRODUCTION (XIAMEN) CO., LTD.]3Current NDC, Legacy NDC, 1 package rows20241016_af08c1fe-fb1a-56d2-e053-2a95a90a67c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283616bacitracin zinc 400 UNT / neomycin sulfate 3.5 MG / polymixin B sulfate 5000 UNT in 1 GM Topical CreamPSNaf08c1fe-fb1a-56d2-e053-2a95a90a67c43
283616bacitracin 400 UNT/ML / neomycin 3.5 MG/ML / polymyxin B 5000 UNT/ML Topical CreamSCDaf08c1fe-fb1a-56d2-e053-2a95a90a67c43
283616bacitracin zinc 400 UNT / neomycin sulfate 3.5 MG / polymixin B sulfate 5000 UNT in 1 GM Topical CreamSYaf08c1fe-fb1a-56d2-e053-2a95a90a67c43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50814-058-0150814005801.9 g in 1 PACKAGE (50814-058-01) 2020-01-010000-00-00NoNoCurrent