FDA.reportPublic FDA data

Neomycin and Polymyxin B Sulfates and Hydrocortisone

Product NDC
61314-646
11-digit product format
613140646
Labeler code
61314
Product ID
61314-646_2a1e7a16-dc94-4cf1-b01f-89e1d7355170
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
neomycin sulfate, polymyxin b sulfate and hydrocortisone
Dosage form
SOLUTION
Route
AURICULAR (OTIC)
Labeler
Sandoz Inc
Application
ANDA062423
Marketing category
ANDA
Marketing start
2003-03-18
Substance
NEOMYCIN SULFATE; POLYMYXIN B SULFATE; HYDROCORTISONE
Active strength
3.5; 10000; 10 mg/mL; [iU]/mL; mg/mL
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 43.

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
A062423-001NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONEHYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSOLUTION/DROPS / OTICAT1983-08-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A062423-001AT

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A062423-001NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSOLUTION/DROPS / OTICAT1983-08-2584e616aacf4f…
2026-08-18 06:07:402026-07A062423-001NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSOLUTION/DROPS / OTICAT1983-08-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A062423-001NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSOLUTION/DROPS / OTICAT1983-08-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062423-001NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSOLUTION/DROPS / OTICAT1983-08-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A062423-001NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSOLUTION/DROPS / OTICAT1983-08-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062423-001NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSOLUTION/DROPS / OTICAT1983-08-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062423-001NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSOLUTION/DROPS / OTICAT1983-08-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062423-001NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSOLUTION/DROPS / OTICAT1983-08-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062423-001NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSOLUTION/DROPS / OTICAT1983-08-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062423-001NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSOLUTION/DROPS / OTICAT1983-08-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062423-001NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSOLUTION/DROPS / OTICAT1983-08-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062423-001NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSOLUTION/DROPS / OTICAT1983-08-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062423-001NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSOLUTION/DROPS / OTICAT1983-08-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062423-001NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSOLUTION/DROPS / OTICAT1983-08-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062423-001NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSOLUTION/DROPS / OTICAT1983-08-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062423-001NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSOLUTION/DROPS / OTICAT1983-08-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062423-001NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSOLUTION/DROPS / OTICAT1983-08-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062423-001NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSOLUTION/DROPS / OTICAT1983-08-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062423-001NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSOLUTION/DROPS / OTICAT1983-08-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062423-001NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSOLUTION/DROPS / OTICAT1983-08-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062423-001NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSOLUTION/DROPS / OTICAT1983-08-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062423-001NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSOLUTION/DROPS / OTICAT1983-08-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A062423-001NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSOLUTION/DROPS / OTICAT1983-08-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A062423-001NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSOLUTION/DROPS / OTICAT1983-08-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A062423-001NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSOLUTION/DROPS / OTICAT1983-08-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A062423-001NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSOLUTION/DROPS / OTICAT1983-08-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A062423-001NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSOLUTION/DROPS / OTICAT1983-08-253f01610625f2…
2019-09-15 20:21 UTC2019-09A062423-001NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSOLUTION/DROPS / OTICAT1983-08-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A062423-001NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSOLUTION/DROPS / OTICAT1983-08-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A062423-001NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSOLUTION/DROPS / OTICAT1983-08-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A062423-001NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSOLUTION/DROPS / OTICAT1983-08-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A062423-001NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSOLUTION/DROPS / OTICAT1983-08-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A062423-001NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSOLUTION/DROPS / OTICAT1983-08-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A062423-001NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSOLUTION/DROPS / OTICAT1983-08-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A062423-001NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSOLUTION/DROPS / OTICAT1983-08-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A062423-001NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSOLUTION/DROPS / OTICAT1983-08-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A062423-001NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSOLUTION/DROPS / OTICAT1983-08-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A062423-001NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSOLUTION/DROPS / OTICAT1983-08-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A062423-001NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSOLUTION/DROPS / OTICAT1983-08-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A062423-001NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSOLUTION/DROPS / OTICAT1983-08-25f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A062423-001AT184e616aacf4f…
2026-08-18 06:07:402026-07A062423-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A062423-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062423-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A062423-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062423-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062423-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062423-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062423-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062423-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062423-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062423-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062423-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062423-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062423-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062423-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062423-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062423-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062423-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062423-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062423-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062423-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A062423-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A062423-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A062423-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A062423-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A062423-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A062423-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A062423-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A062423-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A062423-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A062423-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A062423-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A062423-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A062423-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A062423-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A062423-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A062423-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A062423-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A062423-001AT1f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Neomycin and Polymyxin B Sulfates and Hydrocortisone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEOMYCIN SULFATE3.5 mg/mL
POLYMYXIN B SULFATE10000 [iU]/mL
HYDROCORTISONE10 mg/mL

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
WI4X0X7BPJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
204423Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ff34da77-5e96-4ed1-8c28-ba0b2f35576aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61314-646-10Neomycin and Polymyxin B Sulfates and Hydrocortisone1 in 1 CARTONSOLUTION15
61314-646-10Neomycin and Polymyxin B Sulfates and Hydrocortisone10 mL in 1 BOTTLESOLUTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61314-646-10ML - Milliliter61314-646a9b23921-e9cc-4c3f-a651-d780b128763012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SOLUTION [FALCON PHARMACEUTICALS, LTD.]1
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SOLUTION [FALCON PHARMACEUTICALS, LTD.]1
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SOLUTION [FALCON PHARMACEUTICALS, LTD.]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SOLUTION [FALCON PHARMACEUTICALS, LTD.]1
NEOMYCINACTIVE MOIETYI16QD7X297NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SOLUTION [FALCON PHARMACEUTICALS, LTD.]1
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SOLUTION [FALCON PHARMACEUTICALS, LTD.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SOLUTION [FALCON PHARMACEUTICALS, LTD.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SOLUTION [FALCON PHARMACEUTICALS, LTD.]1
POTASSIUM METABISULFITEINACTIVE INGREDIENT65OE787Q7WNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SOLUTION [FALCON PHARMACEUTICALS, LTD.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SOLUTION [FALCON PHARMACEUTICALS, LTD.]1
WATERINACTIVE INGREDIENT059QF0KO0RNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SOLUTION [FALCON PHARMACEUTICALS, LTD.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61314-646NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SOLUTION [SANDOZ INC]4Current NDC, Legacy NDC, 2 package rows20231109_ff34da77-5e96-4ed1-8c28-ba0b2f35576a.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONESandoz Incff34da77-5e96-4ed1-8c28-ba0b2f35576a2025-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062423
application number: ANDA062423
ndc (product): 61314-646
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONEProficient Rx LPf5ef71ae-fca9-4a57-ae88-f2b2d195a1792022-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062423
application number: ANDA062423

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204423neomycin sulfate 0.35 % / polymyxin B sulfate 10,000 UNT/ML / hydrocortisone 1 % Otic SolutionPSNff34da77-5e96-4ed1-8c28-ba0b2f35576a5
204423neomycin sulfate 0.35 % / polymyxin B sulfate 10,000 UNT/ML / hydrocortisone 1 % Otic SolutionPSN2b1b7fdf-bbcf-47dc-9e27-5ddf0e14ba835
204423neomycin sulfate 0.35 % / polymyxin B sulfate 10,000 UNT/ML / hydrocortisone 1 % Otic SolutionPSNf5ef71ae-fca9-4a57-ae88-f2b2d195a1795
204423hydrocortisone 10 MG/ML / neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML Otic SolutionSCD2b1b7fdf-bbcf-47dc-9e27-5ddf0e14ba835
204423hydrocortisone 10 MG/ML / neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML Otic SolutionSCDff34da77-5e96-4ed1-8c28-ba0b2f35576a5
204423hydrocortisone 10 MG/ML / neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML Otic SolutionSCDf5ef71ae-fca9-4a57-ae88-f2b2d195a1795
204423hydrocortisone 1 % / neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10,000 UNT/ML Otic SolutionSYff34da77-5e96-4ed1-8c28-ba0b2f35576a5
204423hydrocortisone 1 % / neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10,000 UNT/ML Otic SolutionSY2b1b7fdf-bbcf-47dc-9e27-5ddf0e14ba835
204423hydrocortisone 1 % / neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10,000 UNT/ML Otic SolutionSYf5ef71ae-fca9-4a57-ae88-f2b2d195a1795
204423hydrocortisone 10 MG / neomycin 3.5 MG / polymyxin B 10,000 UNT per ML Otic SolutionSYff34da77-5e96-4ed1-8c28-ba0b2f35576a5
204423hydrocortisone 10 MG / neomycin 3.5 MG / polymyxin B 10,000 UNT per ML Otic SolutionSY2b1b7fdf-bbcf-47dc-9e27-5ddf0e14ba835
204423hydrocortisone 10 MG / neomycin 3.5 MG / polymyxin B 10,000 UNT per ML Otic SolutionSYf5ef71ae-fca9-4a57-ae88-f2b2d195a1795
204423neomycin sulfate 0.35 % / polymyxin B sulfate 10,000 UNT/ML / hydrocortisone 1 % Otic SolutionPSNdff05f2e-c51b-e4c3-e053-2995a90a745d2
204423hydrocortisone 10 MG/ML / neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML Otic SolutionSCDdff05f2e-c51b-e4c3-e053-2995a90a745d2
204423hydrocortisone 1 % / neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10,000 UNT/ML Otic SolutionSYdff05f2e-c51b-e4c3-e053-2995a90a745d2
204423hydrocortisone 10 MG / neomycin 3.5 MG / polymyxin B 10,000 UNT per ML Otic SolutionSYdff05f2e-c51b-e4c3-e053-2995a90a745d2
204423neomycin sulfate 0.35 % / polymyxin B sulfate 10,000 UNT/ML / hydrocortisone 1 % Otic SolutionPSN1e04bb0c-85b2-5c2e-e063-6394a90ac30d1
204423hydrocortisone 10 MG/ML / neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML Otic SolutionSCD1e04bb0c-85b2-5c2e-e063-6394a90ac30d1
204423hydrocortisone 1 % / neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10,000 UNT/ML Otic SolutionSY1e04bb0c-85b2-5c2e-e063-6394a90ac30d1
204423hydrocortisone 10 MG / neomycin 3.5 MG / polymyxin B 10,000 UNT per ML Otic SolutionSY1e04bb0c-85b2-5c2e-e063-6394a90ac30d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61314-646-10613140646101 BOTTLE in 1 CARTON (61314-646-10) / 10 mL in 1 BOTTLE1 bottle2003-03-180000-00-00NoNoCurrent