FDA.reportPublic FDA data

RENEW SKIN REPAIR

Product NDC
61924-405
Requested package NDC
61924-405-05
11-digit product format
619240405
Labeler code
61924
Product ID
61924-405_9c598909-7909-e69a-e053-2995a90a1402
Type
HUMAN OTC DRUG
Nonproprietary name
OTC SKIN PROTECTANT DRUG PRODUCTS
Dosage form
CREAM
Route
TOPICAL
Labeler
Dermarite Industries LLC
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-03-03
Marketing end
0000-00-00
Substance
DIMETHICONE
Active strength
0 g/100g
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 packagepackage61924-40561924-405-05IInactivated 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 · 9 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
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
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
61924-405-042026-01-29DRUG LISTING: RENEW SKIN REPAIR CREAM
61924-405-052026-01-29DRUG LISTING: RENEW SKIN REPAIR CREAM
61924-405-272026-01-29DRUG LISTING: RENEW SKIN REPAIR CREAM
61924-405-322026-01-29DRUG LISTING: RENEW SKIN REPAIR CREAM
61924-405-042024-12-06DRUG LISTING: RENEW SKIN REPAIR CREAM
61924-405-052024-12-06DRUG LISTING: RENEW SKIN REPAIR CREAM
61924-405-272024-12-06DRUG LISTING: RENEW SKIN REPAIR CREAM
61924-405-322024-12-06DRUG LISTING: RENEW SKIN REPAIR CREAM
61924-405-042022-01-28DRUG LISTING: RENEW SKIN REPAIR CREAM
61924-405-052022-01-28DRUG LISTING: RENEW SKIN REPAIR CREAM
61924-405-272022-01-28DRUG LISTING: RENEW SKIN REPAIR CREAM
61924-405-322022-01-28DRUG LISTING: RENEW SKIN REPAIR CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61924-405-04RENEW SKIN REPAIR113 g in 1 TUBECREAM1137
61924-405-05RENEW SKIN REPAIR5 g in 1 PACKETCREAM57
61924-405-27RENEW SKIN REPAIR793 g in 1 BAGCREAM7937
61924-405-32RENEW SKIN REPAIR907 g in 1 BOTTLE, PUMPCREAM9077

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1ORENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]3
DIMETHICONEACTIVE MOIETY92RU3N3Y1ORENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]3
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0RENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]3
Aloe Vera LeafINACTIVE INGREDIENTZY81Z83H0XRENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]3
Ascorbyl PalmitateINACTIVE INGREDIENTQN83US2B0NRENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]3
ButylparabenINACTIVE INGREDIENT3QPI1U3FV8RENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]3
Canola OilINACTIVE INGREDIENT331KBJ17RKRENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]3
CARBOMER 940INACTIVE INGREDIENT4Q93RCW27ERENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]3
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SRENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]3
CholecalciferolINACTIVE INGREDIENT1C6V77QF41RENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]3
Corn OilINACTIVE INGREDIENT8470G57WFMRENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KRENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]3
EthylparabenINACTIVE INGREDIENT14255EXE39RENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]3
GlycerinINACTIVE INGREDIENTPDC6A3C0OXRENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]3
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4RENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]3
IsobutylparabenINACTIVE INGREDIENT0QQJ25X58GRENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]3
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TRENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]3
NiacinamideINACTIVE INGREDIENT25X51I8RD4RENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]3
Olive OilINACTIVE INGREDIENT6UYK2W1W1ERENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]3
PEG-100 StearateINACTIVE INGREDIENTYD01N1999RRENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]3
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TRENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]3
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3RENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]3
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHRENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]3
Pyridoxine HydrochlorideINACTIVE INGREDIENT68Y4CF58BVRENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]3
Stearic AcidINACTIVE INGREDIENT4ELV7Z65APRENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]3
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKRENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]3
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCRENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]3
WaterINACTIVE INGREDIENT059QF0KO0RRENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61924-405RENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]7Legacy NDC, 4 package rows20241208_871cd64d-c3a5-4be9-a8fc-ce8bc28a5f71.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61924-405-05619240405055 g in 1 PACKET (61924-405-05) 5 g2011-03-030000-00-00NoNoCurrent