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

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 productproduct69888-102IInactivated by FDA2026-10-05
excluded packagepackage69888-10269888-102-02IInactivated 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 · 40 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 packagepackage69888-102-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69888-102-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69888-102-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69888-102-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69888-102-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69888-102-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69888-102-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69888-102-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69888-102-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69888-102-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69888-102-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69888-102-02557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage69888-102-028af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage69888-102-02834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage69888-102-021332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage69888-102-02fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage69888-102-0286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage69888-102-02bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage69888-102-028dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage69888-102-02e2bbac7714bc…27bdfed8d636…

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
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#

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