Expression

Product NDC
42248-106
11-digit product format
422480106
Labeler code
42248
Product ID
42248-106_0005afe5-6eb3-4eea-baee-21c117b4528b
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE
Dosage form
CREAM
Route
TOPICAL
Labeler
Zenith Medicosm SL
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-08-15
Marketing end
0000-00-00
Substance
OCTINOXATE
Active strength
4 mL/50mL
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 productproduct42248-106IInactivated by FDA2026-09-14
excluded packagepackage42248-10642248-106-02IInactivated by FDA2026-09-14

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 packagepackage42248-106-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42248-106-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42248-106-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42248-106-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42248-106-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42248-106-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42248-106-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42248-106-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42248-106-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42248-106-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42248-106-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42248-106-02557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage42248-106-028af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage42248-106-02834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage42248-106-021332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage42248-106-02fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage42248-106-0286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage42248-106-02bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage42248-106-028dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage42248-106-02e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage42248-106-029bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage42248-106-02110d247fa046…a55b01930146…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42248-106-022019-11-13C16284748780-197449f38-d547-f6ea-e053-dbdaa90aa703Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42248-106-02ExpressionMarine1 in 1 BOXCREAM14
42248-106-02ExpressionMarine50 mL in 1 JARCREAM504

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51EXPRESSION MARINE (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]4
OCTINOXATEACTIVE MOIETY4Y5P7MUD51EXPRESSION MARINE (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]4
ACETYL HEXAPEPTIDE-3INACTIVE INGREDIENTL4EL31FWILEXPRESSION MARINE (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]4
ALLANTOININACTIVE INGREDIENT344S277G0ZEXPRESSION MARINE (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]4
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0EXPRESSION MARINE (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]4
BRONOPOLINACTIVE INGREDIENT6PU1E16C9WEXPRESSION MARINE (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]4
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UEXPRESSION MARINE (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]4
CETEARYL ETHYLHEXANOATEINACTIVE INGREDIENT9M64UO4C25EXPRESSION MARINE (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]4
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SEXPRESSION MARINE (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]4
COLLAGEN, SOLUBLE, FISH SKININACTIVE INGREDIENT8JC99XGU4WEXPRESSION MARINE (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]4
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OEXPRESSION MARINE (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]4
FD&C RED NO. 4INACTIVE INGREDIENTX3W0AM1JLXEXPRESSION MARINE (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXEXPRESSION MARINE (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]4
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSEXPRESSION MARINE (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]4
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPEXPRESSION MARINE (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]4
PEG-8 STEARATEINACTIVE INGREDIENT2P9L47VI5EEXPRESSION MARINE (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]4
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TEXPRESSION MARINE (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHEXPRESSION MARINE (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]4
SACCHARIDE ISOMERATEINACTIVE INGREDIENTW8K377W98IEXPRESSION MARINE (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]4
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKEXPRESSION MARINE (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]4
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCEXPRESSION MARINE (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]4
WATERINACTIVE INGREDIENT059QF0KO0REXPRESSION MARINE (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]4
WHEAT GERMINACTIVE INGREDIENTYR3G369F5AEXPRESSION MARINE (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42248-106EXPRESSION MARINE (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]4Legacy NDC, 2 package rows20120123_c1e1efee-1b21-4dea-8afc-ea3372becf1d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42248-106-02422480106021 in 1 BOXHistorical