Ultra Glow Fade

Product NDC
58318-002
11-digit product format
583180002
Labeler code
58318
Product ID
58318-002_3a988b2a-78e4-4250-bb4a-670403b086e1
Type
HUMAN OTC DRUG
Nonproprietary name
Hydroquinone, Padimate O
Dosage form
CREAM
Route
TOPICAL
Labeler
Keystone Laboratories
Application
part358A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
1964-04-07
Marketing end
0000-00-00
Substance
HYDROQUINONE; PADIMATE O
Active strength
1 g/57g; g/57g
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct58318-002IInactivated by FDA2026-10-05
excluded packagepackage58318-00258318-002-01IInactivated 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 · 44 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 packagepackage58318-002-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage58318-002-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage58318-002-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage58318-002-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage58318-002-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage58318-002-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage58318-002-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage58318-002-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage58318-002-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage58318-002-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage58318-002-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage58318-002-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage58318-002-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage58318-002-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage58318-002-011332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage58318-002-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage58318-002-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage58318-002-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage58318-002-018dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage58318-002-01e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage58318-002-019bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage58318-002-01110d247fa046…a55b01930146…

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
58318-002-012019-11-27C16284748780-19855e2a2-3507-60a7-e053-dbdaa90a05bdc0cc6cd4-8dea-4615-b763-2733f1582a66

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58318-002-01Ultra Glow Fadewith Aloe Vera57 g in 1 CANISTERCREAM573

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROQUINONEACTIVE INGREDIENTXV74C1N1AEULTRA GLOW FADE WITH ALOE VERA (HYDROQUINONE, PADIMATE O) CREAM [KEYSTONE LABORATORIES]3
PADIMATE OACTIVE INGREDIENTZ11006CMUZULTRA GLOW FADE WITH ALOE VERA (HYDROQUINONE, PADIMATE O) CREAM [KEYSTONE LABORATORIES]3
HYDROQUINONEACTIVE MOIETYXV74C1N1AEULTRA GLOW FADE WITH ALOE VERA (HYDROQUINONE, PADIMATE O) CREAM [KEYSTONE LABORATORIES]3
PADIMATE OACTIVE MOIETYZ11006CMUZULTRA GLOW FADE WITH ALOE VERA (HYDROQUINONE, PADIMATE O) CREAM [KEYSTONE LABORATORIES]3
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XULTRA GLOW FADE WITH ALOE VERA (HYDROQUINONE, PADIMATE O) CREAM [KEYSTONE LABORATORIES]3
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KULTRA GLOW FADE WITH ALOE VERA (HYDROQUINONE, PADIMATE O) CREAM [KEYSTONE LABORATORIES]3
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNULTRA GLOW FADE WITH ALOE VERA (HYDROQUINONE, PADIMATE O) CREAM [KEYSTONE LABORATORIES]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPULTRA GLOW FADE WITH ALOE VERA (HYDROQUINONE, PADIMATE O) CREAM [KEYSTONE LABORATORIES]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KULTRA GLOW FADE WITH ALOE VERA (HYDROQUINONE, PADIMATE O) CREAM [KEYSTONE LABORATORIES]3
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4ULTRA GLOW FADE WITH ALOE VERA (HYDROQUINONE, PADIMATE O) CREAM [KEYSTONE LABORATORIES]3
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSULTRA GLOW FADE WITH ALOE VERA (HYDROQUINONE, PADIMATE O) CREAM [KEYSTONE LABORATORIES]3
METHYL ALCOHOLINACTIVE INGREDIENTY4S76JWI15ULTRA GLOW FADE WITH ALOE VERA (HYDROQUINONE, PADIMATE O) CREAM [KEYSTONE LABORATORIES]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TULTRA GLOW FADE WITH ALOE VERA (HYDROQUINONE, PADIMATE O) CREAM [KEYSTONE LABORATORIES]3
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPULTRA GLOW FADE WITH ALOE VERA (HYDROQUINONE, PADIMATE O) CREAM [KEYSTONE LABORATORIES]3
PROPYL GALLATEINACTIVE INGREDIENT8D4SNN7V92ULTRA GLOW FADE WITH ALOE VERA (HYDROQUINONE, PADIMATE O) CREAM [KEYSTONE LABORATORIES]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ULTRA GLOW FADE WITH ALOE VERA (HYDROQUINONE, PADIMATE O) CREAM [KEYSTONE LABORATORIES]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHULTRA GLOW FADE WITH ALOE VERA (HYDROQUINONE, PADIMATE O) CREAM [KEYSTONE LABORATORIES]3
SODIUM DITHIONATEINACTIVE INGREDIENTRPF7Z41GAWULTRA GLOW FADE WITH ALOE VERA (HYDROQUINONE, PADIMATE O) CREAM [KEYSTONE LABORATORIES]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JULTRA GLOW FADE WITH ALOE VERA (HYDROQUINONE, PADIMATE O) CREAM [KEYSTONE LABORATORIES]3
SODIUM SULFITEINACTIVE INGREDIENTVTK01UQK3GULTRA GLOW FADE WITH ALOE VERA (HYDROQUINONE, PADIMATE O) CREAM [KEYSTONE LABORATORIES]3
STEARETH-20INACTIVE INGREDIENTL0Q8IK9E08ULTRA GLOW FADE WITH ALOE VERA (HYDROQUINONE, PADIMATE O) CREAM [KEYSTONE LABORATORIES]3
STEARYL STEARATEINACTIVE INGREDIENT5WX2EGD0DKULTRA GLOW FADE WITH ALOE VERA (HYDROQUINONE, PADIMATE O) CREAM [KEYSTONE LABORATORIES]3
WATERINACTIVE INGREDIENT059QF0KO0RULTRA GLOW FADE WITH ALOE VERA (HYDROQUINONE, PADIMATE O) CREAM [KEYSTONE LABORATORIES]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58318-002ULTRA GLOW FADE WITH ALOE VERA (HYDROQUINONE, PADIMATE O) CREAM [KEYSTONE LABORATORIES]3Legacy NDC, 1 package rows20131118_c0cc6cd4-8dea-4615-b763-2733f1582a66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
153031hydroquinone 2 % Topical CreamPSNc0cc6cd4-8dea-4615-b763-2733f1582a663
153031hydroquinone 20 MG/ML Topical CreamSCDc0cc6cd4-8dea-4615-b763-2733f1582a663
153031hydroquinone 2 % Topical CreamSYc0cc6cd4-8dea-4615-b763-2733f1582a663

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
58318-002-015831800020157 g in 1 CANISTER57 gHistorical