Aerosoothe

Product NDC
55305-123
11-digit product format
553050123
Labeler code
55305
Product ID
55305-123_3d84e0ce-c23f-9d49-e063-6294a90ae9cd
Type
HUMAN OTC DRUG
Nonproprietary name
Triple Antibiotic Ointment
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Aero Healthcare US LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-10-20
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400; 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
Aerosoothe
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC400 [iU]/g
NEOMYCIN SULFATE5 mg/g
POLYMYXIN B SULFATE5000 [iU]/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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55305-123-01Aerosoothe0.9 g in 1 PACKETOINTMENT0.96
55305-123-02Aerosoothe25 in 1 BOXOINTMENT256
55305-123-03Aerosoothe0.5 g in 1 PACKETOINTMENT0.56

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55305-123AEROSOOTHE (TRIPLE ANTIBIOTIC OINTMENT) OINTMENT [AERO HEALTHCARE US LLC]5Current NDC, Legacy NDC, 3 package rows20250228_2287a31c-750c-728d-e054-00144ff88e88.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 OintmentPSN2287a31c-750c-728d-e054-00144ff88e886
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD2287a31c-750c-728d-e054-00144ff88e886
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY2287a31c-750c-728d-e054-00144ff88e886

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55305-123-01553050123010.9 g in 1 PACKET0.9 gHistorical
55305-123-025530501230225 PACKET in 1 BOX (55305-123-02) / .9 g in 1 PACKET (55305-123-01) 25 packet2016-02-010000-00-00NoNoCurrent
55305-123-0355305012303.5 g in 1 PACKET (55305-123-03) 2015-10-200000-00-00NoNoCurrent