NuDermRxPAK 60

Product NDC
70859-048
11-digit product format
708590048
Labeler code
70859
Product ID
70859-048_89a98b7c-d36a-6016-e053-2a95a90aa31b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dimethicone, Calcipotriene
Dosage form
KIT
Route
TOPICAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
NDA020554
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1996-10-01
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2020-12-31
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 productproduct70859-048IInactivated by FDA2026-08-17
excluded packagepackage70859-04870859-048-01IInactivated by FDA2026-08-17

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 · 38 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 packagepackage70859-048-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70859-048-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70859-048-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70859-048-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70859-048-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70859-048-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70859-048-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70859-048-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70859-048-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70859-048-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70859-048-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70859-048-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage70859-048-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage70859-048-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage70859-048-011332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage70859-048-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage70859-048-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage70859-048-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage70859-048-018dfbde2a14a4…c9ff85d89658…

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
N020554-001DOVONEXCALCIPOTRIENE0.005%CREAM / TOPICALABRLD, RS1996-07-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N020554-001AB

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 06:07:402026-07N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-2287673890dc5c…
2021-03-12 10:30 UTC2021-03N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-223f01610625f2…
2019-09-15 20:21 UTC2019-09N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-22b00525d2431f…
2019-07-19 19:46 UTC2019-07N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-223f0d92c62455…
2023-05-13 08:27 UTC2023-05N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-22053a50430f4f…
2023-01-26 05:58 UTC2023-01N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-22e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N020554-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020554-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020554-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020554-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020554-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020554-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020554-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020554-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020554-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020554-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020554-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020554-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020554-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020554-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020554-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020554-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020554-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020554-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020554-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020554-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020554-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020554-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N020554-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020554-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020554-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020554-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N020554-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N020554-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020554-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020554-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020554-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020554-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020554-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020554-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020554-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N020554-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N020554-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020554-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020554-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020554-001AB1e64feba35796…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
bbdc14c7-d940-43b5-a2f7-36c425991f3cProduct name120240320
4d1338f1-f50a-5bb5-4946-11534fdee48fProduct name220210527
7fea2046-07a9-4bb6-9409-828ac6f1f6dfProduct name120210201
f059f1a2-0e64-4839-9a7f-42687c91a44bProduct name120201007
c148aeb5-688c-9b49-a40f-30a41e3595e4Product name220180419
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
07737a91-49bd-c707-82e4-7a6a1660aef6Product name220150616
6f16fc1e-e77d-460f-8810-a12ca121425cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70859-048-012021-01-29C16284748780-1ba0f9c33-30b1-a910-e053-dadaa90a0b8589a98b7c-d36b-6016-e053-2a95a90aa31b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66993-877-61NuDermRxPAK 6060 g in 1 TUBECREAM60 g50 ug in 1g1
68599-0203-4NuDermRxPAK 60118 mL in 1 TUBECREAM118 mL50 mg in 1mL1
70859-048-01NuDermRxPAK 601 in 1 KITKIT11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70859-048-01EA - Each70859-0482df6feb6-46d8-46ce-831f-2fa8f3c0df3e12019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70859-048NUDERMRXPAK 60 (DIMETHICONE, CALCIPOTRIENE) KIT [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 3 package rows20190525_89a98b7c-d36b-6016-e053-2a95a90aa31b.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
CalcipotrieneCALCIPOTRIENEPrasco Laboratories377eafda-737c-4ba2-9ec5-61209b8814ed2022-12-12Warnings, Adverse reactionsExact identifier
application applno (NDA): 020554
application number: NDA020554

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313921calcipotriene 0.005 % Topical CreamPSN89a98b7c-d36b-6016-e053-2a95a90aa31b1
259090dimethicone 5 % Topical CreamPSN89a98b7c-d36b-6016-e053-2a95a90aa31b1
313921calcipotriene 0.05 MG/ML Topical CreamSCD89a98b7c-d36b-6016-e053-2a95a90aa31b1
259090dimethicone 50 MG/ML Topical CreamSCD89a98b7c-d36b-6016-e053-2a95a90aa31b1
313921calcipotriene (as calcipotriene monohydrate) 0.005 % Topical CreamSY89a98b7c-d36b-6016-e053-2a95a90aa31b1
313921calcipotriene 0.005 % Topical CreamSY89a98b7c-d36b-6016-e053-2a95a90aa31b1
259090dimethicone 5 % Topical CreamSY89a98b7c-d36b-6016-e053-2a95a90aa31b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
66993-877-616699308776160 g in 1 TUBE60 gHistorical
68599-0203-468599020304118 mL in 1 TUBE118 mlHistorical
70859-048-01708590048011 in 1 KITHistorical