Locoid Lipocream

Product NDC
16781-384
11-digit product format
167810384
Labeler code
16781
Product ID
16781-384_d087a8ef-b68a-49f2-a4db-e708a49addc1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCORTISONE BUTYRATE
Dosage form
CREAM
Route
TOPICAL
Labeler
Bausch Health US, LLC
Application
NDA020769
Marketing category
NDA
Marketing start
2013-07-03
Marketing end
0000-00-00
Substance
HYDROCORTISONE BUTYRATE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct16781-384DDiscontinued by firm2026-08-03
excluded packagepackage16781-38416781-384-18DDiscontinued by firm2026-08-03
excluded packagepackage16781-38416781-384-45DDiscontinued by firm2026-08-03
excluded packagepackage16781-38416781-384-60DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 20 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct16781-384DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage16781-38416781-384-60DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage16781-38416781-384-45DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage16781-38416781-384-18DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproduct16781-384DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage16781-38416781-384-60DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage16781-38416781-384-45DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage16781-38416781-384-18DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct16781-384DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage16781-38416781-384-60DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage16781-38416781-384-45DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage16781-38416781-384-18DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproduct16781-384DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage16781-38416781-384-60DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage16781-38416781-384-45DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage16781-38416781-384-18DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage16781-38416781-384-60DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage16781-38416781-384-18DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage16781-38416781-384-60DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage16781-38416781-384-18DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…

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
N020769-001LOCOID LIPOCREAMHYDROCORTISONE BUTYRATE0.1%CREAM / TOPICALAB2RLD, RS1997-09-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N020769-001AB2

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 UTC2026-02N020769-001LOCOID LIPOCREAM0.1%CREAM / TOPICALAB2RLD, RS1997-09-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020769-001LOCOID LIPOCREAM0.1%CREAM / TOPICALAB2RLD, RS1997-09-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N020769-001LOCOID LIPOCREAM0.1%CREAM / TOPICALAB2RLD, RS1997-09-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020769-001LOCOID LIPOCREAM0.1%CREAM / TOPICALAB2RLD, RS1997-09-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020769-001LOCOID LIPOCREAM0.1%CREAM / TOPICALAB2RLD, RS1997-09-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020769-001LOCOID LIPOCREAM0.1%CREAM / TOPICALAB2RLD, RS1997-09-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020769-001LOCOID LIPOCREAM0.1%CREAM / TOPICALAB2RLD, RS1997-09-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020769-001LOCOID LIPOCREAM0.1%CREAM / TOPICALAB2RLD, RS1997-09-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020769-001LOCOID LIPOCREAM0.1%CREAM / TOPICALAB2RLD, RS1997-09-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020769-001LOCOID LIPOCREAM0.1%CREAM / TOPICALAB2RLD, RS1997-09-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020769-001LOCOID LIPOCREAM0.1%CREAM / TOPICALAB2RLD, RS1997-09-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020769-001LOCOID LIPOCREAM0.1%CREAM / TOPICALAB2RLD, RS1997-09-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020769-001LOCOID LIPOCREAM0.1%CREAM / TOPICALAB2RLD, RS1997-09-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020769-001LOCOID LIPOCREAM0.1%CREAM / TOPICALAB2RLD, RS1997-09-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020769-001LOCOID LIPOCREAM0.1%CREAM / TOPICALAB2RLD, RS1997-09-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020769-001LOCOID LIPOCREAM0.1%CREAM / TOPICALAB2RLD, RS1997-09-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020769-001LOCOID LIPOCREAM0.1%CREAM / TOPICALAB2RLD, RS1997-09-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020769-001LOCOID LIPOCREAM0.1%CREAM / TOPICALAB2RLD, RS1997-09-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020769-001LOCOID LIPOCREAM0.1%CREAM / TOPICALAB2RLD, RS1997-09-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020769-001LOCOID LIPOCREAM0.1%CREAM / TOPICALAB2RLD, RS1997-09-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020769-001LOCOID LIPOCREAM0.1%CREAM / TOPICALAB2RLD, RS1997-09-0887673890dc5c…
2021-03-12 10:30 UTC2021-03N020769-001LOCOID LIPOCREAM0.1%CREAM / TOPICALAB2RLD, RS1997-09-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020769-001LOCOID LIPOCREAM0.1%CREAM / TOPICALAB2RLD, RS1997-09-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020769-001LOCOID LIPOCREAM0.1%CREAM / TOPICALAB2RLD, RS1997-09-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020769-001LOCOID LIPOCREAM0.1%CREAM / TOPICALAB2RLD, RS1997-09-083f01610625f2…
2019-09-15 20:21 UTC2019-09N020769-001LOCOID LIPOCREAM0.1%CREAM / TOPICALAB2RLD, RS1997-09-08b00525d2431f…
2019-07-19 19:46 UTC2019-07N020769-001LOCOID LIPOCREAM0.1%CREAM / TOPICALAB2RLD, RS1997-09-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020769-001LOCOID LIPOCREAM0.1%CREAM / TOPICALAB2RLD, RS1997-09-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020769-001LOCOID LIPOCREAM0.1%CREAM / TOPICALAB2RLD, RS1997-09-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020769-001LOCOID LIPOCREAM0.1%CREAM / TOPICALAB2RLD, RS1997-09-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020769-001LOCOID LIPOCREAM0.1%CREAM / TOPICALAB2RLD, RS1997-09-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020769-001LOCOID LIPOCREAM0.1%CREAM / TOPICALAB2RLD, RS1997-09-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020769-001LOCOID LIPOCREAM0.1%CREAM / TOPICALAB2RLD, RS1997-09-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020769-001LOCOID LIPOCREAM0.1%CREAM / TOPICALAB2RLD, RS1997-09-083f0d92c62455…
2023-05-13 08:27 UTC2023-05N020769-001LOCOID LIPOCREAM0.1%CREAM / TOPICALAB2RLD, RS1997-09-08053a50430f4f…
2023-01-26 05:58 UTC2023-01N020769-001LOCOID LIPOCREAM0.1%CREAM / TOPICALAB2RLD, RS1997-09-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020769-001LOCOID LIPOCREAM0.1%CREAM / TOPICALAB2RLD, RS1997-09-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020769-001LOCOID LIPOCREAM0.1%CREAM / TOPICALAB2RLD, RS1997-09-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020769-001LOCOID LIPOCREAM0.1%CREAM / TOPICALAB2RLD, RS1997-09-08e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020769-001LOCOID LIPOCREAM0.1%CREAM / TOPICALAB2RLD, RS1997-09-08cb3db0bc1861…

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 UTC2026-02N020769-001AB21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020769-001AB2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020769-001AB216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020769-001AB21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020769-001AB21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020769-001AB2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020769-001AB212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020769-001AB215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020769-001AB21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020769-001AB21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020769-001AB2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020769-001AB21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020769-001AB211e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020769-001AB218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020769-001AB215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020769-001AB215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020769-001AB214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020769-001AB2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020769-001AB21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020769-001AB21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020769-001AB2187673890dc5c…
2021-03-12 10:30 UTC2021-03N020769-001AB215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020769-001AB218869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020769-001AB21c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020769-001AB213f01610625f2…
2019-09-15 20:21 UTC2019-09N020769-001AB21b00525d2431f…
2019-07-19 19:46 UTC2019-07N020769-001AB21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020769-001AB216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020769-001AB211c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020769-001AB21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020769-001AB21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020769-001AB219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020769-001AB21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020769-001AB213f0d92c62455…
2023-05-13 08:27 UTC2023-05N020769-001AB21053a50430f4f…
2023-01-26 05:58 UTC2023-01N020769-001AB213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020769-001AB213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020769-001AB21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020769-001AB21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020769-001AB21cb3db0bc1861…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocortisone ButyrateHYDROCORTISONE BUTYRATEOceanside Pharmaceuticalsddf699f4-1ae0-48c3-8d2a-56aa1a2c5bc12025-06-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 020769
application number: NDA020769

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16781-384-45GM - Gram16781-384a0ca3853-0a8f-4495-9362-21bf3c4127e212014-12-01
16781-384-60GM - Gram16781-384b1c6972f-11c1-411f-b306-01fda6a934b812014-12-01

DailyMed Socrata Ingredients#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16781-384-45167810384451 TUBE in 1 CARTON (16781-384-45) > 45 g in 1 TUBE1 tube2013-07-030000-00-00NoNoCurrent
16781-384-60167810384601 TUBE in 1 CARTON (16781-384-60) > 60 g in 1 TUBE1 tube2013-07-030000-00-00NoNoCurrent