FDA.reportPublic FDA data

P1P Skin Rebirth Cream

Product NDC
69579-103
11-digit product format
695790103
Labeler code
69579
Product ID
69579-103_42a365db-1d93-435c-b585-41a0783a8e31
Type
HUMAN OTC DRUG
Nonproprietary name
Dimethicone, Adenosine
Dosage form
CREAM
Route
TOPICAL
Labeler
Phytos Co., Ltd.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2015-01-26
Marketing end
0000-00-00
Substance
DIMETHICONE; ADENOSINE
Active strength
0 1/30mL; 1/30mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69579-103-022020-01-31C16284748780-19d75b9d0-b1cd-f424-e053-dadaa90a57ceP1P Skin Rebirth Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69579-103-01P1P Skin Rebirth Cream30 mL in 1 CONTAINERCREAM301
69579-103-02P1P Skin Rebirth Cream1 in 1 CARTONCREAM11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
adenosineACTIVE INGREDIENTK72T3FS567P1P SKIN REBIRTH CREAM (DIMETHICONE, ADENOSINE) CREAM [PHYTOS CO., LTD.]1
dimethiconeACTIVE INGREDIENT92RU3N3Y1OP1P SKIN REBIRTH CREAM (DIMETHICONE, ADENOSINE) CREAM [PHYTOS CO., LTD.]1
ADENOSINEACTIVE MOIETYK72T3FS567P1P SKIN REBIRTH CREAM (DIMETHICONE, ADENOSINE) CREAM [PHYTOS CO., LTD.]1
DIMETHICONEACTIVE MOIETY92RU3N3Y1OP1P SKIN REBIRTH CREAM (DIMETHICONE, ADENOSINE) CREAM [PHYTOS CO., LTD.]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0P1P SKIN REBIRTH CREAM (DIMETHICONE, ADENOSINE) CREAM [PHYTOS CO., LTD.]1
1,2-HEXANEDIOLINACTIVE INGREDIENTTR046Y3K1GP1P SKIN REBIRTH CREAM (DIMETHICONE, ADENOSINE) CREAM [PHYTOS CO., LTD.]1
ACEGLUTAMIDEINACTIVE INGREDIENT01J18G9G97P1P SKIN REBIRTH CREAM (DIMETHICONE, ADENOSINE) CREAM [PHYTOS CO., LTD.]1
ARGININEINACTIVE INGREDIENT94ZLA3W45FP1P SKIN REBIRTH CREAM (DIMETHICONE, ADENOSINE) CREAM [PHYTOS CO., LTD.]1
ARTEMISIA VULGARIS ROOTINACTIVE INGREDIENT32MP823R8SP1P SKIN REBIRTH CREAM (DIMETHICONE, ADENOSINE) CREAM [PHYTOS CO., LTD.]1
BASIC FIBROBLAST GROWTH FACTOR (HUMAN)INACTIVE INGREDIENTS3529G9M9VP1P SKIN REBIRTH CREAM (DIMETHICONE, ADENOSINE) CREAM [PHYTOS CO., LTD.]1
BATILOLINACTIVE INGREDIENT39YR661C4UP1P SKIN REBIRTH CREAM (DIMETHICONE, ADENOSINE) CREAM [PHYTOS CO., LTD.]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RAP1P SKIN REBIRTH CREAM (DIMETHICONE, ADENOSINE) CREAM [PHYTOS CO., LTD.]1
CENTELLA ASIATICAINACTIVE INGREDIENT7M867G6T1UP1P SKIN REBIRTH CREAM (DIMETHICONE, ADENOSINE) CREAM [PHYTOS CO., LTD.]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SP1P SKIN REBIRTH CREAM (DIMETHICONE, ADENOSINE) CREAM [PHYTOS CO., LTD.]1
cetyl ethylhexanoateINACTIVE INGREDIENT134647WMX4P1P SKIN REBIRTH CREAM (DIMETHICONE, ADENOSINE) CREAM [PHYTOS CO., LTD.]1
CITRUS PARADISI SEEDINACTIVE INGREDIENT12F08874Y7P1P SKIN REBIRTH CREAM (DIMETHICONE, ADENOSINE) CREAM [PHYTOS CO., LTD.]1
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)INACTIVE INGREDIENTH895X08VNQP1P SKIN REBIRTH CREAM (DIMETHICONE, ADENOSINE) CREAM [PHYTOS CO., LTD.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KP1P SKIN REBIRTH CREAM (DIMETHICONE, ADENOSINE) CREAM [PHYTOS CO., LTD.]1
EGG PHOSPHOLIPIDSINACTIVE INGREDIENT1Z74184RGVP1P SKIN REBIRTH CREAM (DIMETHICONE, ADENOSINE) CREAM [PHYTOS CO., LTD.]1
ethylhexylglycerinINACTIVE INGREDIENT147D247K3PP1P SKIN REBIRTH CREAM (DIMETHICONE, ADENOSINE) CREAM [PHYTOS CO., LTD.]1
FIBROBLAST GROWTH FACTOR-1INACTIVE INGREDIENTG53298VN9YP1P SKIN REBIRTH CREAM (DIMETHICONE, ADENOSINE) CREAM [PHYTOS CO., LTD.]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXP1P SKIN REBIRTH CREAM (DIMETHICONE, ADENOSINE) CREAM [PHYTOS CO., LTD.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4P1P SKIN REBIRTH CREAM (DIMETHICONE, ADENOSINE) CREAM [PHYTOS CO., LTD.]1
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4THP1P SKIN REBIRTH CREAM (DIMETHICONE, ADENOSINE) CREAM [PHYTOS CO., LTD.]1
isododecaneINACTIVE INGREDIENTA8289P68Y2P1P SKIN REBIRTH CREAM (DIMETHICONE, ADENOSINE) CREAM [PHYTOS CO., LTD.]1
LAURYL TRISILOXANEINACTIVE INGREDIENT5OHO78HI1DP1P SKIN REBIRTH CREAM (DIMETHICONE, ADENOSINE) CREAM [PHYTOS CO., LTD.]1
MEADOWFOAM SEED OILINACTIVE INGREDIENT412ZHA4T4YP1P SKIN REBIRTH CREAM (DIMETHICONE, ADENOSINE) CREAM [PHYTOS CO., LTD.]1
MECASERMININACTIVE INGREDIENT7GR9I2683OP1P SKIN REBIRTH CREAM (DIMETHICONE, ADENOSINE) CREAM [PHYTOS CO., LTD.]1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UP1P SKIN REBIRTH CREAM (DIMETHICONE, ADENOSINE) CREAM [PHYTOS CO., LTD.]1
NEPIDERMININACTIVE INGREDIENTTZK30RF92WP1P SKIN REBIRTH CREAM (DIMETHICONE, ADENOSINE) CREAM [PHYTOS CO., LTD.]1
octanediolINACTIVE INGREDIENT806K32R50ZP1P SKIN REBIRTH CREAM (DIMETHICONE, ADENOSINE) CREAM [PHYTOS CO., LTD.]1
PALMITOYL OLIGOPEPTIDEINACTIVE INGREDIENTHO4ZT5S86CP1P SKIN REBIRTH CREAM (DIMETHICONE, ADENOSINE) CREAM [PHYTOS CO., LTD.]1
PALMITOYL TETRAPEPTIDE-7INACTIVE INGREDIENTQ41S464P1RP1P SKIN REBIRTH CREAM (DIMETHICONE, ADENOSINE) CREAM [PHYTOS CO., LTD.]1
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)INACTIVE INGREDIENT255PIF62MSP1P SKIN REBIRTH CREAM (DIMETHICONE, ADENOSINE) CREAM [PHYTOS CO., LTD.]1
poloxamer 407INACTIVE INGREDIENTTUF2IVW3M2P1P SKIN REBIRTH CREAM (DIMETHICONE, ADENOSINE) CREAM [PHYTOS CO., LTD.]1
polysorbate 20INACTIVE INGREDIENT7T1F30V5YHP1P SKIN REBIRTH CREAM (DIMETHICONE, ADENOSINE) CREAM [PHYTOS CO., LTD.]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HP1P SKIN REBIRTH CREAM (DIMETHICONE, ADENOSINE) CREAM [PHYTOS CO., LTD.]1
SODIUM ASCORBYL PHOSPHATEINACTIVE INGREDIENT836SJG51DRP1P SKIN REBIRTH CREAM (DIMETHICONE, ADENOSINE) CREAM [PHYTOS CO., LTD.]1
SODIUM DEHYDROACETATEINACTIVE INGREDIENT8W46YN971GP1P SKIN REBIRTH CREAM (DIMETHICONE, ADENOSINE) CREAM [PHYTOS CO., LTD.]1
stearic acidINACTIVE INGREDIENT4ELV7Z65APP1P SKIN REBIRTH CREAM (DIMETHICONE, ADENOSINE) CREAM [PHYTOS CO., LTD.]1
totarolINACTIVE INGREDIENT67NH2854WWP1P SKIN REBIRTH CREAM (DIMETHICONE, ADENOSINE) CREAM [PHYTOS CO., LTD.]1
TREMELLA FUCIFORMIS WHOLEINACTIVE INGREDIENT4938BNS0GUP1P SKIN REBIRTH CREAM (DIMETHICONE, ADENOSINE) CREAM [PHYTOS CO., LTD.]1
waterINACTIVE INGREDIENT059QF0KO0RP1P SKIN REBIRTH CREAM (DIMETHICONE, ADENOSINE) CREAM [PHYTOS CO., LTD.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69579-103P1P SKIN REBIRTH CREAM (DIMETHICONE, ADENOSINE) CREAM [PHYTOS CO., LTD.]1Legacy NDC, 2 package rows20150129_d815532b-8e76-4db9-8086-ac055501af90.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
69579-103-016957901030130 mL in 1 CONTAINER30 mlHistorical
69579-103-02695790103021 in 1 CARTONHistorical