FDA.reportPublic FDA data

PRIMEROSE EGF

Product NDC
69888-102
11-digit product format
698880102
Labeler code
69888
Product ID
69888-102_7f899eae-76d6-a1e8-e053-2991aa0a0c09
Type
HUMAN OTC DRUG
Nonproprietary name
Niacinamide, Dimethicone, Adenosine
Dosage form
CREAM
Route
TOPICAL
Labeler
Royal Springs Cosmetics USA, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2018-02-13
Marketing end
0000-00-00
Substance
NIACINAMIDE; DIMETHICONE; ADENOSINE
Active strength
0 1/100mL; 1/100mL; 1/100mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
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
69888-102-022020-09-27C16284748780-1ab0e2407-2c94-f274-e053-dbdaa90a6471PRIMEROSE EGF REPAIRING CREAM
69888-102-022020-09-25C16284748780-1ab0e2407-2c94-f274-e053-dbdaa90a6471PRIMEROSE EGF REPAIRING CREAM
69888-102-022020-07-22C16284748780-1ab0e2407-2c94-f274-e053-dbdaa90a6471PRIMEROSE EGF REPAIRING CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69888-102-01PRIMEROSE EGF100 mL in 1 CONTAINERCREAM1008
69888-102-02PRIMEROSE EGF1 in 1 BOXCREAM18

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ADENOSINEACTIVE INGREDIENTK72T3FS567PRIMEROSE EGF (NIACINAMIDE, DIMETHICONE, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]4
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OPRIMEROSE EGF (NIACINAMIDE, DIMETHICONE, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]4
NIACINAMIDEACTIVE INGREDIENT25X51I8RD4PRIMEROSE EGF (NIACINAMIDE, DIMETHICONE, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]4
ADENOSINEACTIVE MOIETYK72T3FS567PRIMEROSE EGF (NIACINAMIDE, DIMETHICONE, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]4
DIMETHICONEACTIVE MOIETY92RU3N3Y1OPRIMEROSE EGF (NIACINAMIDE, DIMETHICONE, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]4
NIACINAMIDEACTIVE MOIETY25X51I8RD4PRIMEROSE EGF (NIACINAMIDE, DIMETHICONE, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]4
AMYLOPECTININACTIVE INGREDIENT4XO4QFV777PRIMEROSE EGF (NIACINAMIDE, DIMETHICONE, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]4
ArginineINACTIVE INGREDIENT94ZLA3W45FPRIMEROSE EGF (NIACINAMIDE, DIMETHICONE, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]4
ASIAN GINSENGINACTIVE INGREDIENTCUQ3A77YXIPRIMEROSE EGF (NIACINAMIDE, DIMETHICONE, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]4
Butylene GlycolINACTIVE INGREDIENT3XUS85K0RAPRIMEROSE EGF (NIACINAMIDE, DIMETHICONE, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]4
CALCIUM PANTOTHENATEINACTIVE INGREDIENT568ET80C3DPRIMEROSE EGF (NIACINAMIDE, DIMETHICONE, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]4
CARAMELINACTIVE INGREDIENTT9D99G2B1RPRIMEROSE EGF (NIACINAMIDE, DIMETHICONE, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]4
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SPRIMEROSE EGF (NIACINAMIDE, DIMETHICONE, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]4
CETYL ETHYLHEXANOATEINACTIVE INGREDIENT134647WMX4PRIMEROSE EGF (NIACINAMIDE, DIMETHICONE, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]4
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RPRIMEROSE EGF (NIACINAMIDE, DIMETHICONE, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]4
CYCLOMETHICONE 6INACTIVE INGREDIENTXHK3U310BAPRIMEROSE EGF (NIACINAMIDE, DIMETHICONE, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]4
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)INACTIVE INGREDIENT9E4CO0W6C5PRIMEROSE EGF (NIACINAMIDE, DIMETHICONE, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]4
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUPRIMEROSE EGF (NIACINAMIDE, DIMETHICONE, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPRIMEROSE EGF (NIACINAMIDE, DIMETHICONE, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]4
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4PRIMEROSE EGF (NIACINAMIDE, DIMETHICONE, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]4
GLYCYRRHIZINATE DIPOTASSIUMINACTIVE INGREDIENTCA2Y0FE3FXPRIMEROSE EGF (NIACINAMIDE, DIMETHICONE, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]4
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4THPRIMEROSE EGF (NIACINAMIDE, DIMETHICONE, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]4
ISOHEXADECANEINACTIVE INGREDIENT918X1OUF1EPRIMEROSE EGF (NIACINAMIDE, DIMETHICONE, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]4
MACADAMIA OILINACTIVE INGREDIENT515610SU8CPRIMEROSE EGF (NIACINAMIDE, DIMETHICONE, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]4
MaltodextrinINACTIVE INGREDIENT7CVR7L4A2DPRIMEROSE EGF (NIACINAMIDE, DIMETHICONE, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]4
Neopentyl Glycol DiheptanoateINACTIVE INGREDIENT5LKW3C543XPRIMEROSE EGF (NIACINAMIDE, DIMETHICONE, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]4
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RPRIMEROSE EGF (NIACINAMIDE, DIMETHICONE, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]4
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TPRIMEROSE EGF (NIACINAMIDE, DIMETHICONE, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]4
POLYACRYLAMIDE (10000 MW)INACTIVE INGREDIENTE2KR9C9V2IPRIMEROSE EGF (NIACINAMIDE, DIMETHICONE, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]4
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MPRIMEROSE EGF (NIACINAMIDE, DIMETHICONE, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPRIMEROSE EGF (NIACINAMIDE, DIMETHICONE, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]4
POMEGRANATEINACTIVE INGREDIENT56687D1Z4DPRIMEROSE EGF (NIACINAMIDE, DIMETHICONE, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]4
PYRIDOXINE HYDROCHLORIDEINACTIVE INGREDIENT68Y4CF58BVPRIMEROSE EGF (NIACINAMIDE, DIMETHICONE, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PRIMEROSE EGF (NIACINAMIDE, DIMETHICONE, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]4
SODIUM ASCORBYL PHOSPHATEINACTIVE INGREDIENT836SJG51DRPRIMEROSE EGF (NIACINAMIDE, DIMETHICONE, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]4
WATERINACTIVE INGREDIENT059QF0KO0RPRIMEROSE EGF (NIACINAMIDE, DIMETHICONE, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69888-102PRIMEROSE EGF (NIACINAMIDE, DIMETHICONE, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]8Legacy NDC, 2 package rows20190118_a0c8db45-e524-4ac0-b83d-e506eb7ba124.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
69888-102-0169888010201100 mL in 1 CONTAINER100 mlHistorical
69888-102-02698880102021 in 1 BOXHistorical