Cellapy A Repair Cream

Product NDC
69278-103
Requested package NDC
69278-103-02
11-digit product format
692780103
Labeler code
69278
Product ID
69278-103_9ca07fe8-9e9a-da60-e053-2995a90a2ecc
Type
HUMAN OTC DRUG
Nonproprietary name
Ceramide 3
Dosage form
CREAM
Route
TOPICAL
Labeler
GM Holdings Co., Ltd
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2014-10-15
Marketing end
0000-00-00
Substance
CERAMIDE 3
Active strength
0 1/100mL
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69278-10369278-103-02IInactivated 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 · 18 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…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
69278-103-022022-01-28C16284748780-1d6a99b39-85f2-a426-e053-dadaa90af4c2Cellapy A Repair Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69278-103-01Cellapy A Repair Cream100 mL in 1 TUBECREAM1005
69278-103-02Cellapy A Repair Cream1 in 1 CARTONCREAM15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CERAMIDE 3ACTIVE INGREDIENT4370DF050BCELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]4
CERAMIDE 3ACTIVE MOIETY4370DF050BCELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]4
1,2-HEXANEDIOLINACTIVE INGREDIENTTR046Y3K1GCELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]4
ALCEA ROSEA FLOWERINACTIVE INGREDIENT1250O8MKPZCELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]4
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XCELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]4
ASIAN GINSENGINACTIVE INGREDIENTCUQ3A77YXICELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]4
ASPARAGUS COCHINCHINENSIS TUBERINACTIVE INGREDIENTIZW9WN28HWCELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]4
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RACELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]4
C12-20 ALKYL GLUCOSIDEINACTIVE INGREDIENTK67N5Z1RUACELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]4
C14-22 ALCOHOLSINACTIVE INGREDIENTB1K89384RJCELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]4
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UCELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]4
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SCELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]4
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RCELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]4
CYCLOMETHICONE 6INACTIVE INGREDIENTXHK3U310BACELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]4
ELEUTHEROINACTIVE INGREDIENTZQH6VH092ZCELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]4
FALLOPIA MULTIFLORA ROOTINACTIVE INGREDIENTAUZ3VD75MCCELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]4
glycerinINACTIVE INGREDIENTPDC6A3C0OXCELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]4
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4CELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]4
GRAPEFRUITINACTIVE INGREDIENTO82C39RR8CCELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]4
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4THCELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]4
HYDROGENATED POLYDECENE (550 MW)INACTIVE INGREDIENTU333RI6EB7CELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]4
HYDROGENATED SOYBEAN LECITHININACTIVE INGREDIENTH1109Z9J4NCELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]4
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)INACTIVE INGREDIENTR33S7TK2EPCELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]4
MEADOWFOAM SEED OILINACTIVE INGREDIENT412ZHA4T4YCELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]4
NEPIDERMININACTIVE INGREDIENTTZK30RF92WCELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]4
olive oilINACTIVE INGREDIENT6UYK2W1W1ECELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]4
OMEGA-3 FATTY ACIDSINACTIVE INGREDIENT71M78END5SCELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]4
panthenolINACTIVE INGREDIENTWV9CM0O67ZCELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]4
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RCELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]4
peg-40 stearateINACTIVE INGREDIENTECU18C66Q7CELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]4
PHYTOSPHINGOSINEINACTIVE INGREDIENTGIN46U9Q2QCELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]4
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MCELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]4
PURSLANEINACTIVE INGREDIENTM6S840WXG5CELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]4
SALIX ALBA BARKINACTIVE INGREDIENT205MXS71H7CELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]4
SCIADOPITYS VERTICILLATA ROOTINACTIVE INGREDIENT4BXP7G02TJCELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]4
shea butterINACTIVE INGREDIENTK49155WL9YCELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]4
SODIUM POLYACRYLATE (8000 MW)INACTIVE INGREDIENT285CYO341LCELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]4
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XCELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]4
SQUALANEINACTIVE INGREDIENTGW89575KF9CELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]4
STAR ANISE FRUITINACTIVE INGREDIENTCK15HA8438CELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]4
TREHALOSEINACTIVE INGREDIENTB8WCK70T7ICELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]4
TRICAPRYLININACTIVE INGREDIENT6P92858988CELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]4
TROPOLONEINACTIVE INGREDIENT7L6DL16P1TCELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]4
waterINACTIVE INGREDIENT059QF0KO0RCELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]4
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VCELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69278-103CELLAPY A REPAIR CREAM (CERAMIDE 3) CREAM [GM HOLDINGS CO., LTD]5Legacy NDC, 2 package rows20200121_ab6c3292-67e1-4390-b838-9e2b257e636d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69278-103-02692780103021 TUBE in 1 CARTON (69278-103-02) > 100 mL in 1 TUBE (69278-103-01) 1 tube2020-01-210000-00-00NoNoCurrent