FDA.reportPublic FDA data

Triple Antibiotic HC

Product NDC
57319-344
11-digit product format
573190344
Labeler code
57319
Product ID
57319-344_8b45f06d-ad0b-447a-ab1d-14cab8ca4043
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Neomycin sulfate and Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Phoenix Pharmaceutical, Inc.
Application
ANDA064068
Marketing category
ANDA
Marketing start
1995-10-30
Marketing end
0000-00-00
Substance
NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC; HYDROCORTISONE
Active strength
4 mg/g; [USP'U]/g; [USP'U]/g; mg/g
Pharmacologic classes
Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS],Decreased Cell Wall Synthesis & Repair [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct57319-344IInactivated by FDA2026-08-11
excluded packagepackage57319-34457319-344-25IInactivated by FDA2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57319-344-25d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57319-344-25f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57319-344-252ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57319-344-25a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57319-344-25cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57319-344-25cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57319-344-25302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57319-344-25ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57319-344-250efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57319-344-25ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage57319-344-25367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage57319-344-25557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage57319-344-258af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage57319-344-25834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage57319-344-251332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage57319-344-25fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage57319-344-2586f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage57319-344-25bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage57319-344-258dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage57319-344-25e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage57319-344-259bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage57319-344-25110d247fa046…a55b01930146…

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
A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONEBACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICRS1995-10-30

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 UTC2026-02A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICRS1995-10-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICRS1995-10-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICRS1995-10-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICRS1995-10-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICRS1995-10-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICRS1995-10-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICRS1995-10-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICRS1995-10-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICRS1995-10-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICRS1995-10-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICRS1995-10-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICRS1995-10-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICRS1995-10-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICRS1995-10-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-10-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-10-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-10-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-10-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-10-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-10-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-10-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-10-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-10-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-10-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-10-303f01610625f2…
2019-09-15 20:21 UTC2019-09A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-10-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-10-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICRS1995-10-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICRS1995-10-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICRS1995-10-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICRS1995-10-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICRS1995-10-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICRS1995-10-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICRS1995-10-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICRS1995-10-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-10-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-10-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-10-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-10-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-10-30cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064068-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A064068-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A064068-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A064068-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A064068-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A064068-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A064068-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A064068-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A064068-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A064068-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A064068-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A064068-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A064068-001AT1ea99ee380514…
2023-01-26 05:58 UTC2023-01A064068-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A064068-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A064068-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A064068-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A064068-001AT1cb3db0bc1861…

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
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57319-344-252019-10-29C16284748780-1960f7f55-da4b-8e05-e053-dbdaa90a074aNeomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone Ophthalmic Ointment, USP (Sterile)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57319-344-25Triple Antibiotic HC3.5 g in 1 TUBEOINTMENT3.51
57319-344-25Triple Antibiotic HC1 in 1 CARTONOINTMENT11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ESTRIPLE ANTIBIOTIC HC (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE) OINTMENT [PHOENIX PHARMACEUTICAL, INC.]1
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJTRIPLE ANTIBIOTIC HC (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE) OINTMENT [PHOENIX PHARMACEUTICAL, INC.]1
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693TRIPLE ANTIBIOTIC HC (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE) OINTMENT [PHOENIX PHARMACEUTICAL, INC.]1
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4TRIPLE ANTIBIOTIC HC (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE) OINTMENT [PHOENIX PHARMACEUTICAL, INC.]1
BACITRACINACTIVE MOIETY58H6RWO52ITRIPLE ANTIBIOTIC HC (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE) OINTMENT [PHOENIX PHARMACEUTICAL, INC.]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJTRIPLE ANTIBIOTIC HC (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE) OINTMENT [PHOENIX PHARMACEUTICAL, INC.]1
NEOMYCINACTIVE MOIETYI16QD7X297TRIPLE ANTIBIOTIC HC (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE) OINTMENT [PHOENIX PHARMACEUTICAL, INC.]1
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KTRIPLE ANTIBIOTIC HC (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE) OINTMENT [PHOENIX PHARMACEUTICAL, INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPTRIPLE ANTIBIOTIC HC (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE) OINTMENT [PHOENIX PHARMACEUTICAL, INC.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UTRIPLE ANTIBIOTIC HC (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE) OINTMENT [PHOENIX PHARMACEUTICAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57319-344TRIPLE ANTIBIOTIC HC (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE) OINTMENT [PHOENIX PHARMACEUTICAL, INC.]1Legacy NDC, 2 package rows20101202_8b45f06d-ad0b-447a-ab1d-14cab8ca4043.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, Bacitracin Zinc and HydrocortisoneNEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONEBausch & Lomb Incorporated3b00eb5c-dd98-467e-a883-04c37a8ecc422025-01-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064068
application number: ANDA064068

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116150bacitracin zinc 400 UNT / hydrocortisone acetate 10 MG / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per GM Ophthalmic OintmentPSN8b45f06d-ad0b-447a-ab1d-14cab8ca40431
1116150bacitracin zinc 0.4 UNT/MG / hydrocortisone acetate 0.01 MG/MG / neomycin sulfate 0.0035 MG/MG / polymyxin B sulfate 10 UNT/MG Ophthalmic OintmentSCD8b45f06d-ad0b-447a-ab1d-14cab8ca40431
1116150bacitracin zinc 400 UNT/GM / hydrocortisone acetate 1 % / neomycin sulfate 3.5 MG/GM / polymyxin B sulfate 10,000 UNT/GM Ophthalmic OintmentSY8b45f06d-ad0b-447a-ab1d-14cab8ca40431

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
57319-344-25573190344253.5 g in 1 TUBE3.5 gHistorical