FDA.reportPublic FDA data

Neomycin and Polymyxin B Sulfates and Dexamethasone

Product NDC
0574-4160
11-digit product format
005744160
Labeler code
0574
Product ID
0574-4160_300ff594-23be-4bdd-9bf4-d5e71bc5a782
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Neomycin, Polymyxin B Sulfates, Dexamethasone
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Padagis US LLC
Application
ANDA062938
Marketing category
ANDA
Marketing start
2014-07-03
Marketing end
0000-00-00
Substance
DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
1 mg/g; mg/g; [USP'U]/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0574-4160DDiscontinued by firm2026-09-09
excluded packagepackage0574-41600574-4160-35DDiscontinued by firm2026-09-09

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONEDEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC1989-07-31

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC1989-07-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-3187673890dc5c…
2021-03-12 10:30 UTC2021-03A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-313f01610625f2…
2019-09-15 20:21 UTC2019-09A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31b00525d2431f…
2019-07-19 19:46 UTC2019-07A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-313f0d92c62455…
2023-05-13 08:27 UTC2023-05A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31053a50430f4f…
2023-01-26 05:58 UTC2023-01A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A062938-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062938-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A062938-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062938-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062938-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062938-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062938-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062938-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062938-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062938-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062938-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062938-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062938-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062938-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062938-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062938-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062938-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062938-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062938-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062938-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A062938-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A062938-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A062938-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A062938-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A062938-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A062938-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A062938-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A062938-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A062938-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A062938-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A062938-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A062938-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A062938-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A062938-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A062938-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A062938-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A062938-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A062938-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A062938-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A062938-001AT1cb3db0bc1861…

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0574-4160-35GM - Gram0574-4160efa5b018-0e45-4c8c-830f-bd942633733112014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXAMETHASONEACTIVE INGREDIENT7S5I7G3JQLNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.]1
DEXAMETHASONEACTIVE INGREDIENT7S5I7G3JQLNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONE) OINTMENT [PADDOCK LABORATORIES, LLC]1
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.]1
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONE) OINTMENT [PADDOCK LABORATORIES, LLC]1
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.]1
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONE) OINTMENT [PADDOCK LABORATORIES, LLC]1
DEXAMETHASONEACTIVE MOIETY7S5I7G3JQLNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.]1
DEXAMETHASONEACTIVE MOIETY7S5I7G3JQLNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONE) OINTMENT [PADDOCK LABORATORIES, LLC]1
NEOMYCINACTIVE MOIETYI16QD7X297NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.]1
NEOMYCINACTIVE MOIETYI16QD7X297NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONE) OINTMENT [PADDOCK LABORATORIES, LLC]1
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.]1
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONE) OINTMENT [PADDOCK LABORATORIES, LLC]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONE) OINTMENT [PADDOCK LABORATORIES, LLC]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONE) OINTMENT [PADDOCK LABORATORIES, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0574-4160NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONE) OINTMENT [PADAGIS US LLC]5Legacy NDC20241107_c8ae4afe-4f06-4441-9c5b-52f485f8f2f5.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONEProficient Rx LPbd9f3220-6d42-4863-aa2a-b17b138d095d2021-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062938
application number: ANDA062938

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 OintmentPSNd92683cc-b6e0-4e52-aefa-990f3369b4dc10
309679dexamethasone 0.001 MG/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCDd92683cc-b6e0-4e52-aefa-990f3369b4dc10
309679dexamethasone 0.1 % / neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10 UNT/MG Ophthalmic OintmentSYd92683cc-b6e0-4e52-aefa-990f3369b4dc10
309679dexAMETHasone 1 MG / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per GM Ophthalmic OintmentPSNbd9f3220-6d42-4863-aa2a-b17b138d095d3
309679dexamethasone 0.001 MG/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCDbd9f3220-6d42-4863-aa2a-b17b138d095d3
309679dexamethasone 0.1 % / neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10 UNT/MG Ophthalmic OintmentSYbd9f3220-6d42-4863-aa2a-b17b138d095d3
309679dexAMETHasone 1 MG / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per GM Ophthalmic OintmentPSN4aecebf1-2f64-725d-e054-00144ff8d46c2
309679dexamethasone 0.001 MG/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCD4aecebf1-2f64-725d-e054-00144ff8d46c2
309679dexamethasone 0.1 % / neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10 UNT/MG Ophthalmic OintmentSY4aecebf1-2f64-725d-e054-00144ff8d46c2
309679dexAMETHasone 1 MG / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per GM Ophthalmic OintmentPSNc44aae7b-3241-4760-a11f-f620871f14661
309679dexamethasone 0.001 MG/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCDc44aae7b-3241-4760-a11f-f620871f14661
309679dexamethasone 0.1 % / neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10 UNT/MG Ophthalmic OintmentSYc44aae7b-3241-4760-a11f-f620871f14661

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0574-4160-35005744160351 TUBE in 1 CARTON (0574-4160-35) > 3.5 g in 1 TUBE1 tube2014-07-030000-00-00NoNoCurrent