Advanced Firming and Anti Wrinkle

Product NDC
11822-0378
11-digit product format
118220378
Labeler code
11822
Product ID
11822-0378_6a04b548-180e-409e-a8c0-6c2f5038fc0b
Type
HUMAN OTC DRUG
Nonproprietary name
Ensulizole, Octinoxate
Dosage form
CREAM
Route
TOPICAL
Labeler
Rite Aid Corporation
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2010-02-10
Marketing end
0000-00-00
Substance
OCTINOXATE; ENSULIZOLE
Active strength
8 g/100g; g/100g
NDC exclude flag
E
Listing certified through
2018-12-31
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 productproduct11822-0378IInactivated by FDA2026-10-16
excluded packagepackage11822-037811822-0378-0IInactivated by FDA2026-10-16

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage11822-0378-0IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage11822-0378-0IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage11822-0378-0IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage11822-0378-0IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage11822-0378-0IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage11822-0378-0IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage11822-0378-0IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage11822-0378-0IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage11822-0378-0IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage11822-0378-0IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage11822-0378-0IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage11822-0378-0IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage11822-0378-0IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage11822-0378-0IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage11822-0378-0IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage11822-0378-0IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage11822-0378-0IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage11822-0378-0IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage11822-0378-0IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage11822-0378-0IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage11822-0378-0IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage11822-0378-0EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11822-0378-02020-01-31C16284748780-19d75b9d0-03a0-f424-e053-dadaa90a57ceRite Aid Corporation Advanced Firming & Anti-Wrinkle Cream Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-0378-0Advanced Firming and Anti Wrinkle1 in 1 CARTONCREAM12
11822-0378-0Advanced Firming and Anti Wrinkle48 g in 1 JARCREAM482

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ENSULIZOLEACTIVE INGREDIENT9YQ9DI1W42ADVANCED FIRMING AND ANTI WRINKLE (ENSULIZOLE, OCTINOXATE) CREAM [RITE AID CORPORATION]2
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51ADVANCED FIRMING AND ANTI WRINKLE (ENSULIZOLE, OCTINOXATE) CREAM [RITE AID CORPORATION]2
ENSULIZOLEACTIVE MOIETY9YQ9DI1W42ADVANCED FIRMING AND ANTI WRINKLE (ENSULIZOLE, OCTINOXATE) CREAM [RITE AID CORPORATION]2
OCTINOXATEACTIVE MOIETY4Y5P7MUD51ADVANCED FIRMING AND ANTI WRINKLE (ENSULIZOLE, OCTINOXATE) CREAM [RITE AID CORPORATION]2
ALLANTOININACTIVE INGREDIENT344S277G0ZADVANCED FIRMING AND ANTI WRINKLE (ENSULIZOLE, OCTINOXATE) CREAM [RITE AID CORPORATION]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933ADVANCED FIRMING AND ANTI WRINKLE (ENSULIZOLE, OCTINOXATE) CREAM [RITE AID CORPORATION]2
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RAADVANCED FIRMING AND ANTI WRINKLE (ENSULIZOLE, OCTINOXATE) CREAM [RITE AID CORPORATION]2
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SADVANCED FIRMING AND ANTI WRINKLE (ENSULIZOLE, OCTINOXATE) CREAM [RITE AID CORPORATION]2
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RADVANCED FIRMING AND ANTI WRINKLE (ENSULIZOLE, OCTINOXATE) CREAM [RITE AID CORPORATION]2
CYCLOMETHICONE 6INACTIVE INGREDIENTXHK3U310BAADVANCED FIRMING AND ANTI WRINKLE (ENSULIZOLE, OCTINOXATE) CREAM [RITE AID CORPORATION]2
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4ADVANCED FIRMING AND ANTI WRINKLE (ENSULIZOLE, OCTINOXATE) CREAM [RITE AID CORPORATION]2
DIPALMITOYL HYDROXYPROLINEINACTIVE INGREDIENTE6AHA53N1HADVANCED FIRMING AND ANTI WRINKLE (ENSULIZOLE, OCTINOXATE) CREAM [RITE AID CORPORATION]2
DOCOSANOLINACTIVE INGREDIENT9G1OE216XYADVANCED FIRMING AND ANTI WRINKLE (ENSULIZOLE, OCTINOXATE) CREAM [RITE AID CORPORATION]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXADVANCED FIRMING AND ANTI WRINKLE (ENSULIZOLE, OCTINOXATE) CREAM [RITE AID CORPORATION]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4ADVANCED FIRMING AND ANTI WRINKLE (ENSULIZOLE, OCTINOXATE) CREAM [RITE AID CORPORATION]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TADVANCED FIRMING AND ANTI WRINKLE (ENSULIZOLE, OCTINOXATE) CREAM [RITE AID CORPORATION]2
MYRISTYL MYRISTATEINACTIVE INGREDIENT4042ZC00DYADVANCED FIRMING AND ANTI WRINKLE (ENSULIZOLE, OCTINOXATE) CREAM [RITE AID CORPORATION]2
PALMITOYL OLIGOPEPTIDEINACTIVE INGREDIENTHO4ZT5S86CADVANCED FIRMING AND ANTI WRINKLE (ENSULIZOLE, OCTINOXATE) CREAM [RITE AID CORPORATION]2
PALMITOYL TETRAPEPTIDE-7INACTIVE INGREDIENTQ41S464P1RADVANCED FIRMING AND ANTI WRINKLE (ENSULIZOLE, OCTINOXATE) CREAM [RITE AID CORPORATION]2
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RADVANCED FIRMING AND ANTI WRINKLE (ENSULIZOLE, OCTINOXATE) CREAM [RITE AID CORPORATION]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TADVANCED FIRMING AND ANTI WRINKLE (ENSULIZOLE, OCTINOXATE) CREAM [RITE AID CORPORATION]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HADVANCED FIRMING AND ANTI WRINKLE (ENSULIZOLE, OCTINOXATE) CREAM [RITE AID CORPORATION]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ADVANCED FIRMING AND ANTI WRINKLE (ENSULIZOLE, OCTINOXATE) CREAM [RITE AID CORPORATION]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHADVANCED FIRMING AND ANTI WRINKLE (ENSULIZOLE, OCTINOXATE) CREAM [RITE AID CORPORATION]2
SOY ISOFLAVONESINACTIVE INGREDIENT71B37NR06DADVANCED FIRMING AND ANTI WRINKLE (ENSULIZOLE, OCTINOXATE) CREAM [RITE AID CORPORATION]2
SQUALANEINACTIVE INGREDIENTGW89575KF9ADVANCED FIRMING AND ANTI WRINKLE (ENSULIZOLE, OCTINOXATE) CREAM [RITE AID CORPORATION]2
STEARETH-2INACTIVE INGREDIENTV56DFE46J5ADVANCED FIRMING AND ANTI WRINKLE (ENSULIZOLE, OCTINOXATE) CREAM [RITE AID CORPORATION]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APADVANCED FIRMING AND ANTI WRINKLE (ENSULIZOLE, OCTINOXATE) CREAM [RITE AID CORPORATION]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPADVANCED FIRMING AND ANTI WRINKLE (ENSULIZOLE, OCTINOXATE) CREAM [RITE AID CORPORATION]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKADVANCED FIRMING AND ANTI WRINKLE (ENSULIZOLE, OCTINOXATE) CREAM [RITE AID CORPORATION]2
WATERINACTIVE INGREDIENT059QF0KO0RADVANCED FIRMING AND ANTI WRINKLE (ENSULIZOLE, OCTINOXATE) CREAM [RITE AID CORPORATION]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEADVANCED FIRMING AND ANTI WRINKLE (ENSULIZOLE, OCTINOXATE) CREAM [RITE AID CORPORATION]2
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VADVANCED FIRMING AND ANTI WRINKLE (ENSULIZOLE, OCTINOXATE) CREAM [RITE AID CORPORATION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0378ADVANCED FIRMING AND ANTI WRINKLE (ENSULIZOLE, OCTINOXATE) CREAM [RITE AID CORPORATION]2Legacy NDC, 2 package rows20110330_f4e6b23a-f672-487a-9507-7b254f6fe86f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
11822-0378-0118220378001 in 1 CARTONHistorical