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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A064063-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONEDEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1994-07-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A064063-001AT

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A064063-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1994-07-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064063-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1994-07-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A064063-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1994-07-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064063-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1994-07-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064063-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1994-07-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064063-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1994-07-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064063-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1994-07-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064063-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1994-07-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064063-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1994-07-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A064063-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1994-07-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064063-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1994-07-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064063-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1994-07-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064063-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1994-07-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A064063-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1994-07-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064063-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1994-07-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A064063-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1994-07-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A064063-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1994-07-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A064063-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1994-07-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A064063-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1994-07-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A064063-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1994-07-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A064063-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1994-07-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A064063-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1994-07-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A064063-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1994-07-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A064063-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1994-07-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A064063-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1994-07-253f01610625f2…
2019-09-15 20:21 UTC2019-09A064063-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1994-07-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A064063-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1994-07-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A064063-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1994-07-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A064063-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1994-07-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A064063-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1994-07-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A064063-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1994-07-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A064063-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1994-07-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A064063-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1994-07-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A064063-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1994-07-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A064063-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1994-07-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A064063-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1994-07-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A064063-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1994-07-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A064063-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1994-07-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A064063-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1994-07-25e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A064063-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1994-07-25cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A064063-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064063-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A064063-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064063-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064063-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064063-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064063-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064063-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064063-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A064063-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064063-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064063-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064063-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A064063-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064063-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A064063-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A064063-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A064063-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A064063-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A064063-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A064063-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A064063-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A064063-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A064063-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A064063-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A064063-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A064063-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A064063-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A064063-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A064063-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A064063-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A064063-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A064063-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A064063-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A064063-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A064063-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A064063-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A064063-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A064063-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A064063-001AT1cb3db0bc1861…

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
NEOMYCIN SULFATE1 mg/g
POLYMYXIN B SULFATE3.5 mg/g
DEXAMETHASONE10000 [USP'U]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
057Y626693Internal UNII lookup
19371312D4Internal UNII lookup
7S5I7G3JQLInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309679Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4456d10b-9995-4430-b692-a8859ea36debAvailable on FDA.report

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

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONENuCare Pharmaceuticals,Inc.c3b6004a-8cfc-d5f8-e053-2a95a90a3efb2026-01-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064063
application number: ANDA064063
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONEPreferred Pharmaceuticals Inc.e42d4837-77c2-40c3-8705-20966a51a8222026-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064063
application number: ANDA064063
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONENEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONEAdvanced Rx Pharmacy of Tennessee, LLCf1a05d5f-74f2-17a1-e053-2995a90ab0e72024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064063
application number: ANDA064063
Neo/Poly-B/Dex Ophth OintNEO/POLY-B/DEX OPHTH OINTDirect_Rx0ec1dfdf-b63f-fb0c-e063-6294a90a843d2024-01-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064063
application number: ANDA064063
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONEA-S Medication Solutions0d273133-0ce9-4fe6-b873-7f85aac254862023-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064063
application number: ANDA064063
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONEBausch & Lomb Incorporated4456d10b-9995-4430-b692-a8859ea36deb2023-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064063
application number: ANDA064063
ndc (product): 24208-795
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONEProficient Rx LP21c9b34c-af88-4c9e-9b6c-32d78d34ba7e2023-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064063
application number: ANDA064063

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