Porcelana Day Skin Lightening

Product NDC
51545-110
11-digit product format
515450110
Labeler code
51545
Product ID
51545-110_604e5e57-3b7f-3da0-e053-2991aa0a55f8
Type
HUMAN OTC DRUG
Nonproprietary name
Hydroquinone and Octinoxate
Dosage form
CREAM
Route
TOPICAL
Labeler
Ultimark Products LLC
Application
part358A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-04-01
Marketing end
0000-00-00
Substance
HYDROQUINONE; OCTINOXATE
Active strength
0 g/g; g/g
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 productproduct51545-110IInactivated by FDA2026-10-12
excluded packagepackage51545-11051545-110-03IInactivated by FDA2026-10-12

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 · 32 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 packagepackage51545-110-03d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51545-110-03f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51545-110-032ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51545-110-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51545-110-03cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51545-110-03cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51545-110-03302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51545-110-03ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51545-110-030efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51545-110-03ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51545-110-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51545-110-03557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage51545-110-038af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage51545-110-03834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage51545-110-031332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage51545-110-03fb8cb913e6d1…eb8c232b6be0…

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
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51545-110-032022-07-29C16284748780-1e4f33bdf-9fc2-d8a0-e053-dadaa90a6e4ePorcelana Day Skin Lightening Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51545-110-03Porcelana Day Skin Lightening85 g in 1 JARCREAM853
51545-110-03Porcelana Day Skin Lightening1 in 1 BOXCREAM13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROQUINONEACTIVE INGREDIENTXV74C1N1AEPORCELANA DAY SKIN LIGHTENING (HYDROQUINONE AND OCTINOXATE) CREAM [ULTIMARK PRODUCTS LLC]2
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51PORCELANA DAY SKIN LIGHTENING (HYDROQUINONE AND OCTINOXATE) CREAM [ULTIMARK PRODUCTS LLC]2
HYDROQUINONEACTIVE MOIETYXV74C1N1AEPORCELANA DAY SKIN LIGHTENING (HYDROQUINONE AND OCTINOXATE) CREAM [ULTIMARK PRODUCTS LLC]2
OCTINOXATEACTIVE MOIETY4Y5P7MUD51PORCELANA DAY SKIN LIGHTENING (HYDROQUINONE AND OCTINOXATE) CREAM [ULTIMARK PRODUCTS LLC]2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0PORCELANA DAY SKIN LIGHTENING (HYDROQUINONE AND OCTINOXATE) CREAM [ULTIMARK PRODUCTS LLC]2
.BETA.-CAROTENEINACTIVE INGREDIENT01YAE03M7JPORCELANA DAY SKIN LIGHTENING (HYDROQUINONE AND OCTINOXATE) CREAM [ULTIMARK PRODUCTS LLC]2
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KPORCELANA DAY SKIN LIGHTENING (HYDROQUINONE AND OCTINOXATE) CREAM [ULTIMARK PRODUCTS LLC]2
C13-14 ISOPARAFFININACTIVE INGREDIENTE4F12ROE70PORCELANA DAY SKIN LIGHTENING (HYDROQUINONE AND OCTINOXATE) CREAM [ULTIMARK PRODUCTS LLC]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNPORCELANA DAY SKIN LIGHTENING (HYDROQUINONE AND OCTINOXATE) CREAM [ULTIMARK PRODUCTS LLC]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPPORCELANA DAY SKIN LIGHTENING (HYDROQUINONE AND OCTINOXATE) CREAM [ULTIMARK PRODUCTS LLC]2
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4PORCELANA DAY SKIN LIGHTENING (HYDROQUINONE AND OCTINOXATE) CREAM [ULTIMARK PRODUCTS LLC]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPORCELANA DAY SKIN LIGHTENING (HYDROQUINONE AND OCTINOXATE) CREAM [ULTIMARK PRODUCTS LLC]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4PORCELANA DAY SKIN LIGHTENING (HYDROQUINONE AND OCTINOXATE) CREAM [ULTIMARK PRODUCTS LLC]2
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63MPORCELANA DAY SKIN LIGHTENING (HYDROQUINONE AND OCTINOXATE) CREAM [ULTIMARK PRODUCTS LLC]2
MAGNESIUM ASCORBYL PHOSPHATEINACTIVE INGREDIENT0R822556M5PORCELANA DAY SKIN LIGHTENING (HYDROQUINONE AND OCTINOXATE) CREAM [ULTIMARK PRODUCTS LLC]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPORCELANA DAY SKIN LIGHTENING (HYDROQUINONE AND OCTINOXATE) CREAM [ULTIMARK PRODUCTS LLC]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPPORCELANA DAY SKIN LIGHTENING (HYDROQUINONE AND OCTINOXATE) CREAM [ULTIMARK PRODUCTS LLC]2
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RPORCELANA DAY SKIN LIGHTENING (HYDROQUINONE AND OCTINOXATE) CREAM [ULTIMARK PRODUCTS LLC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PORCELANA DAY SKIN LIGHTENING (HYDROQUINONE AND OCTINOXATE) CREAM [ULTIMARK PRODUCTS LLC]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHPORCELANA DAY SKIN LIGHTENING (HYDROQUINONE AND OCTINOXATE) CREAM [ULTIMARK PRODUCTS LLC]2
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CPORCELANA DAY SKIN LIGHTENING (HYDROQUINONE AND OCTINOXATE) CREAM [ULTIMARK PRODUCTS LLC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPORCELANA DAY SKIN LIGHTENING (HYDROQUINONE AND OCTINOXATE) CREAM [ULTIMARK PRODUCTS LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RPORCELANA DAY SKIN LIGHTENING (HYDROQUINONE AND OCTINOXATE) CREAM [ULTIMARK PRODUCTS LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51545-110PORCELANA DAY SKIN LIGHTENING (HYDROQUINONE AND OCTINOXATE) CREAM [ULTIMARK PRODUCTS LLC]3Legacy NDC, 2 package rows20171214_73f8a8a2-7cec-454a-91d1-3c25d525de9a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
153031hydroquinone 2 % Topical CreamPSN73f8a8a2-7cec-454a-91d1-3c25d525de9a3
153031hydroquinone 20 MG/ML Topical CreamSCD73f8a8a2-7cec-454a-91d1-3c25d525de9a3
153031hydroquinone 2 % Topical CreamSY73f8a8a2-7cec-454a-91d1-3c25d525de9a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51545-110-03515450110031 JAR in 1 BOX (51545-110-03) > 85 g in 1 JAR1 jar2017-12-140000-00-00NoNoCurrent