NDC 55305-123

Aerosoothe

Triple Antibiotic Ointment

Aerosoothe is a Topical Ointment in the Human Otc Drug category. It is labeled and distributed by Aero Healthcare Us Llc. The primary component is Polymyxin B Sulfate; Bacitracin Zinc; Neomycin Sulfate.

Product ID55305-123_58ffb850-d58f-0dc0-e053-2a91aa0a1015
NDC55305-123
Product TypeHuman Otc Drug
Proprietary NameAerosoothe
Generic NameTriple Antibiotic Ointment
Dosage FormOintment
Route of AdministrationTOPICAL
Marketing Start Date2015-10-20
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart333B
Labeler NameAero Healthcare US LLC
Substance NamePOLYMYXIN B SULFATE; BACITRACIN ZINC; NEOMYCIN SULFATE
Active Ingredient Strength5000 [iU]/g; [iU]/g; mg/g
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 55305-123-02

25 PACKET in 1 BOX (55305-123-02) > .9 g in 1 PACKET (55305-123-01)
Marketing Start Date2016-02-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55305-123-02 [55305012302]

Aerosoothe OINTMENT
Marketing CategoryOTC monograph final
Application Numberpart333B
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-02-01
Inactivation Date2020-01-31

NDC 55305-123-03 [55305012303]

Aerosoothe OINTMENT
Marketing CategoryOTC monograph final
Application Numberpart333B
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-10-20
Inactivation Date2020-01-31

NDC 55305-123-01 [55305012301]

Aerosoothe OINTMENT
Marketing CategoryOTC monograph final
Application Numberpart333B
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-10-20

Drug Details

Active Ingredients

IngredientStrength
POLYMYXIN B SULFATE5000 [iU]/g

OpenFDA Data

SPL SET ID:2287a31c-750c-728d-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 204602
  • NDC Crossover Matching brand name "Aerosoothe" or generic name "Triple Antibiotic Ointment"

    NDCBrand NameGeneric Name
    55305-123AerosootheTriple Antibiotic Ointment
    70356-101Aftate Triple AntibioticTriple Antibiotic Ointment
    70897-003Triple AntiobioticTriple Antibiotic Ointment
    42961-035Zee 3-in-One First Aid AntibioticTriple Antibiotic Ointment

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