FDA.reportPublic FDA data

Neomycin and Polymyxin B Sulfates and Dexamethasone

Product NDC
24208-795
11-digit product format
242080795
Labeler code
24208
Product ID
24208-795_ec763c42-6065-4d6b-8eb8-7b12c844dac1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Neomycin Sulfate, Polymyxin B Sulfate, and Dexamethasone
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Bausch & Lomb Incorporated
Application
ANDA064063
Marketing category
ANDA
Marketing start
1994-07-25
Substance
DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
1; 3.5; 10000 mg/g; mg/g; [USP'U]/g
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], 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
Neomycin and Polymyxin B Sulfates and Dexamethasone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXAMETHASONE1 mg/g
NEOMYCIN SULFATE3.5 mg/g
POLYMYXIN B SULFATE10000 [USP'U]/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7S5I7G3JQL, 057Y626693, 19371312D4
Rxcui309679

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1ea46721-9071-6b81-fd0a-a82bfbb014ecProduct name720250220
525701df-f985-480d-995a-e0ee70c2bdf4Product name520250128
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
941f67d9-7f03-56d2-750c-36de24f654dbProduct name320221117
d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8Product name220220506
7b2c58e8-5850-4e3e-82e9-b1593b1de761Product name520220210
81e34474-b0a5-434f-8104-25d689efc99eProduct name120200303
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39Product name120190408
0c7dba41-c919-5809-508d-4affe6cfcff2Product name220170817
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
399647c0-db89-02d1-991c-0c17b584482cProduct name120140508
3e9a6377-704f-dff7-b19f-56c98d40c444Product name120140508
4d2e6ff9-14f5-b84f-c39b-373b005712c1Product name120140508
725d71bf-f956-5cad-e556-fa39cb060dc8Product name120140508
9ea85abb-fa68-5da6-ab60-2c7eef579000Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508
d029211e-5e6b-725f-3696-ac6ff77da222Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24208-795-35Neomycin and Polymyxin B Sulfates and Dexamethasone1 in 1 CARTONOINTMENT115
24208-795-35Neomycin and Polymyxin B Sulfates and Dexamethasone3.5 g in 1 TUBEOINTMENT3.515

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24208-795-35GM - Gram24208-7959951113e-2919-409b-a4b1-760d14fadad712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXAMETHASONEACTIVE INGREDIENT7S5I7G3JQLNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONE) OINTMENT [BAUSCH & LOMB INCORPORATED]5
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONE) OINTMENT [BAUSCH & LOMB INCORPORATED]5
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONE) OINTMENT [BAUSCH & LOMB INCORPORATED]5
DEXAMETHASONEACTIVE MOIETY7S5I7G3JQLNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONE) OINTMENT [BAUSCH & LOMB INCORPORATED]5
NEOMYCINACTIVE MOIETYI16QD7X297NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONE) OINTMENT [BAUSCH & LOMB INCORPORATED]5
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONE) OINTMENT [BAUSCH & LOMB INCORPORATED]5
LANOLININACTIVE INGREDIENT7EV65EAW6HNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONE) OINTMENT [BAUSCH & LOMB INCORPORATED]5
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONE) OINTMENT [BAUSCH & LOMB INCORPORATED]5
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONE) OINTMENT [BAUSCH & LOMB INCORPORATED]5
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONE) OINTMENT [BAUSCH & LOMB INCORPORATED]5
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONE) OINTMENT [BAUSCH & LOMB INCORPORATED]5
DEXAMETHASONEACTIVE INGREDIENT7S5I7G3JQLNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
DEXAMETHASONEACTIVE MOIETY7S5I7G3JQLNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
NEOMYCINACTIVE MOIETYI16QD7X297NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
LANOLININACTIVE INGREDIENT7EV65EAW6HNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OINTMENT [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-795NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONE) OINTMENT [BAUSCH & LOMB INCORPORATED]15Current NDC, Legacy NDC, 2 package rows20230808_4456d10b-9995-4430-b692-a8859ea36deb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309679dexAMETHasone 1 MG / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per GM Ophthalmic OintmentPSN4456d10b-9995-4430-b692-a8859ea36deb15
309679dexamethasone 0.001 MG/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCD4456d10b-9995-4430-b692-a8859ea36deb15
309679dexamethasone 0.1 % / neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10 UNT/MG Ophthalmic OintmentSY4456d10b-9995-4430-b692-a8859ea36deb15
309679dexAMETHasone 1 MG / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per GM Ophthalmic OintmentPSN21c9b34c-af88-4c9e-9b6c-32d78d34ba7e5
309679dexamethasone 0.001 MG/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCD21c9b34c-af88-4c9e-9b6c-32d78d34ba7e5
309679dexamethasone 0.1 % / neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10 UNT/MG Ophthalmic OintmentSY21c9b34c-af88-4c9e-9b6c-32d78d34ba7e5
309679dexAMETHasone 1 MG / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per GM Ophthalmic OintmentPSNf1a05d5f-74f2-17a1-e053-2995a90ab0e73
309679dexAMETHasone 1 MG / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per GM Ophthalmic OintmentPSN0d273133-0ce9-4fe6-b873-7f85aac254863
309679dexamethasone 0.001 MG/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCDf1a05d5f-74f2-17a1-e053-2995a90ab0e73
309679dexamethasone 0.001 MG/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCD0d273133-0ce9-4fe6-b873-7f85aac254863
309679dexamethasone 0.1 % / neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10 UNT/MG Ophthalmic OintmentSY0d273133-0ce9-4fe6-b873-7f85aac254863
309679dexamethasone 0.1 % / neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10 UNT/MG Ophthalmic OintmentSYf1a05d5f-74f2-17a1-e053-2995a90ab0e73
309679dexAMETHasone 1 MG / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per GM Ophthalmic OintmentPSNc3b6004a-8cfc-d5f8-e053-2a95a90a3efb2
309679dexAMETHasone 1 MG / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per GM Ophthalmic OintmentPSNe42d4837-77c2-40c3-8705-20966a51a8222
309679dexamethasone 0.001 MG/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCDc3b6004a-8cfc-d5f8-e053-2a95a90a3efb2
309679dexamethasone 0.001 MG/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCDe42d4837-77c2-40c3-8705-20966a51a8222
309679dexamethasone 0.1 % / neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10 UNT/MG Ophthalmic OintmentSYc3b6004a-8cfc-d5f8-e053-2a95a90a3efb2
309679dexamethasone 0.1 % / neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10 UNT/MG Ophthalmic OintmentSYe42d4837-77c2-40c3-8705-20966a51a8222
309679dexAMETHasone 1 MG / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per GM Ophthalmic OintmentPSN0ec1dfdf-b63f-fb0c-e063-6294a90a843d1
309679dexamethasone 0.001 MG/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCD0ec1dfdf-b63f-fb0c-e063-6294a90a843d1
309679dexamethasone 0.1 % / neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10 UNT/MG Ophthalmic OintmentSY0ec1dfdf-b63f-fb0c-e063-6294a90a843d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24208-795-35242080795351 TUBE in 1 CARTON (24208-795-35) / 3.5 g in 1 TUBE1 tube1994-07-250000-00-00NoNoCurrent