Cellapy A Repair

Product NDC
69278-104
11-digit product format
692780104
Labeler code
69278
Product ID
69278-104_9ca0ae73-9a05-2ef0-e053-2995a90afc21
Type
HUMAN OTC DRUG
Nonproprietary name
Ceramide 3
Dosage form
LOTION
Route
TOPICAL
Labeler
GM Holdings Co., Ltd
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2014-10-22
Marketing end
0000-00-00
Substance
CERAMIDE 3
Active strength
0 1/200mL
NDC exclude flag
No
Listing certified through
2021-12-31
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 productproduct69278-104IInactivated by FDA2026-10-05
excluded packagepackage69278-10469278-104-02IInactivated by FDA2026-10-05

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 · 36 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 packagepackage69278-104-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69278-104-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69278-104-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69278-104-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69278-104-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69278-104-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69278-104-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69278-104-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69278-104-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69278-104-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69278-104-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69278-104-02557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage69278-104-028af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage69278-104-02834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage69278-104-021332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage69278-104-02fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage69278-104-0286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage69278-104-02bd6a592717d7…303034d00443…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ef9a935e-31b7-402c-a66c-716cdfe4f126Product name920241218
115c5bd2-98e1-4a98-8292-90803ca7e851Product name120220127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69278-104-022022-01-28C16284748780-1d6a99b39-b9fb-a426-e053-dadaa90af4c2Cellapy A Repair Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69278-104-01Cellapy A Repair200 mL in 1 BOTTLE, PUMPLOTION2004
69278-104-02Cellapy A Repair1 in 1 CARTONLOTION14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Ceramide 3ACTIVE INGREDIENT4370DF050BCELLAPY A REPAIR (CERAMIDE 3) LOTION [GM HOLDINGS CO., LTD]3
CERAMIDE 3ACTIVE MOIETY4370DF050BCELLAPY A REPAIR (CERAMIDE 3) LOTION [GM HOLDINGS CO., LTD]3
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0CELLAPY A REPAIR (CERAMIDE 3) LOTION [GM HOLDINGS CO., LTD]3
1,2-HEXANEDIOLINACTIVE INGREDIENTTR046Y3K1GCELLAPY A REPAIR (CERAMIDE 3) LOTION [GM HOLDINGS CO., LTD]3
ALCEA ROSEA FLOWERINACTIVE INGREDIENT1250O8MKPZCELLAPY A REPAIR (CERAMIDE 3) LOTION [GM HOLDINGS CO., LTD]3
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XCELLAPY A REPAIR (CERAMIDE 3) LOTION [GM HOLDINGS CO., LTD]3
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERINACTIVE INGREDIENTW59H9296ZGCELLAPY A REPAIR (CERAMIDE 3) LOTION [GM HOLDINGS CO., LTD]3
ASIAN GINSENGINACTIVE INGREDIENTCUQ3A77YXICELLAPY A REPAIR (CERAMIDE 3) LOTION [GM HOLDINGS CO., LTD]3
ASPARAGUS COCHINCHINENSIS TUBERINACTIVE INGREDIENTIZW9WN28HWCELLAPY A REPAIR (CERAMIDE 3) LOTION [GM HOLDINGS CO., LTD]3
BETASIZOFIRANINACTIVE INGREDIENT2X51AD1X3TCELLAPY A REPAIR (CERAMIDE 3) LOTION [GM HOLDINGS CO., LTD]3
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RACELLAPY A REPAIR (CERAMIDE 3) LOTION [GM HOLDINGS CO., LTD]3
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UCELLAPY A REPAIR (CERAMIDE 3) LOTION [GM HOLDINGS CO., LTD]3
cetearyl olivateINACTIVE INGREDIENT58B69Q84JOCELLAPY A REPAIR (CERAMIDE 3) LOTION [GM HOLDINGS CO., LTD]3
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SCELLAPY A REPAIR (CERAMIDE 3) LOTION [GM HOLDINGS CO., LTD]3
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RCELLAPY A REPAIR (CERAMIDE 3) LOTION [GM HOLDINGS CO., LTD]3
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OCELLAPY A REPAIR (CERAMIDE 3) LOTION [GM HOLDINGS CO., LTD]3
DIMETHYL SULFONEINACTIVE INGREDIENT9H4PO4Z4FTCELLAPY A REPAIR (CERAMIDE 3) LOTION [GM HOLDINGS CO., LTD]3
ELEUTHEROINACTIVE INGREDIENTZQH6VH092ZCELLAPY A REPAIR (CERAMIDE 3) LOTION [GM HOLDINGS CO., LTD]3
FALLOPIA MULTIFLORA ROOTINACTIVE INGREDIENTAUZ3VD75MCCELLAPY A REPAIR (CERAMIDE 3) LOTION [GM HOLDINGS CO., LTD]3
glycerinINACTIVE INGREDIENTPDC6A3C0OXCELLAPY A REPAIR (CERAMIDE 3) LOTION [GM HOLDINGS CO., LTD]3
GLYCERYL STEARATE SEINACTIVE INGREDIENTFCZ5MH785ICELLAPY A REPAIR (CERAMIDE 3) LOTION [GM HOLDINGS CO., LTD]3
GLYCYRRHIZINATE DIPOTASSIUMINACTIVE INGREDIENTCA2Y0FE3FXCELLAPY A REPAIR (CERAMIDE 3) LOTION [GM HOLDINGS CO., LTD]3
GRAPEFRUITINACTIVE INGREDIENTO82C39RR8CCELLAPY A REPAIR (CERAMIDE 3) LOTION [GM HOLDINGS CO., LTD]3
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4THCELLAPY A REPAIR (CERAMIDE 3) LOTION [GM HOLDINGS CO., LTD]3
HYDROGENATED SOYBEAN LECITHININACTIVE INGREDIENTH1109Z9J4NCELLAPY A REPAIR (CERAMIDE 3) LOTION [GM HOLDINGS CO., LTD]3
MEADOWFOAM SEED OILINACTIVE INGREDIENT412ZHA4T4YCELLAPY A REPAIR (CERAMIDE 3) LOTION [GM HOLDINGS CO., LTD]3
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UCELLAPY A REPAIR (CERAMIDE 3) LOTION [GM HOLDINGS CO., LTD]3
NEPIDERMININACTIVE INGREDIENTTZK30RF92WCELLAPY A REPAIR (CERAMIDE 3) LOTION [GM HOLDINGS CO., LTD]3
olive oilINACTIVE INGREDIENT6UYK2W1W1ECELLAPY A REPAIR (CERAMIDE 3) LOTION [GM HOLDINGS CO., LTD]3
OMEGA-3 FATTY ACIDSINACTIVE INGREDIENT71M78END5SCELLAPY A REPAIR (CERAMIDE 3) LOTION [GM HOLDINGS CO., LTD]3
PHYTOSPHINGOSINEINACTIVE INGREDIENTGIN46U9Q2QCELLAPY A REPAIR (CERAMIDE 3) LOTION [GM HOLDINGS CO., LTD]3
PURSLANEINACTIVE INGREDIENTM6S840WXG5CELLAPY A REPAIR (CERAMIDE 3) LOTION [GM HOLDINGS CO., LTD]3
SALIX ALBA BARKINACTIVE INGREDIENT205MXS71H7CELLAPY A REPAIR (CERAMIDE 3) LOTION [GM HOLDINGS CO., LTD]3
SCIADOPITYS VERTICILLATA ROOTINACTIVE INGREDIENT4BXP7G02TJCELLAPY A REPAIR (CERAMIDE 3) LOTION [GM HOLDINGS CO., LTD]3
SORBITAN OLIVATEINACTIVE INGREDIENTMDL271E3GRCELLAPY A REPAIR (CERAMIDE 3) LOTION [GM HOLDINGS CO., LTD]3
SQUALANEINACTIVE INGREDIENTGW89575KF9CELLAPY A REPAIR (CERAMIDE 3) LOTION [GM HOLDINGS CO., LTD]3
STAR ANISE FRUITINACTIVE INGREDIENTCK15HA8438CELLAPY A REPAIR (CERAMIDE 3) LOTION [GM HOLDINGS CO., LTD]3
TROPOLONEINACTIVE INGREDIENT7L6DL16P1TCELLAPY A REPAIR (CERAMIDE 3) LOTION [GM HOLDINGS CO., LTD]3
waterINACTIVE INGREDIENT059QF0KO0RCELLAPY A REPAIR (CERAMIDE 3) LOTION [GM HOLDINGS CO., LTD]3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECELLAPY A REPAIR (CERAMIDE 3) LOTION [GM HOLDINGS CO., LTD]3
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VCELLAPY A REPAIR (CERAMIDE 3) LOTION [GM HOLDINGS CO., LTD]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69278-104CELLAPY A REPAIR (CERAMIDE 3) LOTION [GM HOLDINGS CO., LTD]4Legacy NDC, 2 package rows20200121_41f0e694-820c-4a4b-81eb-e4ebaed62b69.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69278-104-0169278010401200 mL in 1 BOTTLE, PUMP200 mlHistorical
69278-104-02692780104021 BOTTLE, PUMP in 1 CARTON (69278-104-02) > 200 mL in 1 BOTTLE, PUMP (69278-104-01) 2020-01-210000-00-00NoNoCurrent