FDA.reportPublic FDA data

dabur

Product NDC
68747-3025
11-digit product format
687473025
Labeler code
68747
Product ID
68747-3025_43de6cb3-e462-70c8-e063-6394a90a2b5a
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Dabur India Limited
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-05-17
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400; 3.5; 5000 [USP'U]/g; mg/g; [USP'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
dabur
Brand name suffix
First Aid
Listing expiration
2026-12-31

Active Ingredients#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68747-3025-2daburFirst Aid0.5 g in 1 PACKETOINTMENT0.52
68747-3025-3daburFirst Aid0.9 g in 1 PACKETOINTMENT0.92
68747-3025-4daburFirst Aid14 g in 1 TUBEOINTMENT142
68747-3025-5daburFirst Aid28.3 g in 1 TUBEOINTMENT28.32
68747-3025-6daburFirst Aid56 g in 1 TUBEOINTMENT562

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68747-3025DABUR FIRST AID (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) OINTMENT [DABUR INDIA LIMITED]1Current NDC, 5 package rows20240925_229170a3-ef9e-597d-e063-6394a90acf8b.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 OintmentPSN229170a3-ef9e-597d-e063-6394a90acf8b2
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD229170a3-ef9e-597d-e063-6394a90acf8b2
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY229170a3-ef9e-597d-e063-6394a90acf8b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68747-3025-268747302502.5 g in 1 PACKET (68747-3025-2) 2013-05-17NoNoCurrent
68747-3025-368747302503.9 g in 1 PACKET (68747-3025-3) 2013-05-17NoNoCurrent
68747-3025-46874730250414 g in 1 TUBE (68747-3025-4) 14 g2013-05-17NoNoCurrent
68747-3025-56874730250528.3 g in 1 TUBE (68747-3025-5) 28.3 g2013-05-17NoNoCurrent
68747-3025-66874730250656 g in 1 TUBE (68747-3025-6) 56 g2025-11-01NoNoCurrent