FDA.reportPublic FDA data

HYPERPIGMENTATION TREATMENT

Product NDC
46007-301
Requested package NDC
46007-301-12
11-digit product format
460070301
Labeler code
46007
Product ID
46007-301_d53e0ec1-2b83-48c5-e053-2a95a90aba3e
Type
HUMAN OTC DRUG
Nonproprietary name
HYDROQUINONE
Dosage form
LOTION
Route
TOPICAL
Labeler
Skin Authority LLC
Application
part358A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-04-19
Marketing end
0000-00-00
Substance
HYDROQUINONE
Active strength
2 g/100mL
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage46007-30146007-301-12DDiscontinued by firm2026-08-17

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
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…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROQUINONEACTIVE INGREDIENTXV74C1N1AEHYPERPIGMENTATION TREATMENT (HYDROQUINONE) LOTION [SKIN AUTHORITY LLC]1
HYDROQUINONEACTIVE MOIETYXV74C1N1AEHYPERPIGMENTATION TREATMENT (HYDROQUINONE) LOTION [SKIN AUTHORITY LLC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MHYPERPIGMENTATION TREATMENT (HYDROQUINONE) LOTION [SKIN AUTHORITY LLC]1
ALLANTOININACTIVE INGREDIENT344S277G0ZHYPERPIGMENTATION TREATMENT (HYDROQUINONE) LOTION [SKIN AUTHORITY LLC]1
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0NHYPERPIGMENTATION TREATMENT (HYDROQUINONE) LOTION [SKIN AUTHORITY LLC]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UHYPERPIGMENTATION TREATMENT (HYDROQUINONE) LOTION [SKIN AUTHORITY LLC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPHYPERPIGMENTATION TREATMENT (HYDROQUINONE) LOTION [SKIN AUTHORITY LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KHYPERPIGMENTATION TREATMENT (HYDROQUINONE) LOTION [SKIN AUTHORITY LLC]1
GLYCOLIC ACIDINACTIVE INGREDIENT0WT12SX38SHYPERPIGMENTATION TREATMENT (HYDROQUINONE) LOTION [SKIN AUTHORITY LLC]1
POLYQUATERNIUM-10 (400 CPS AT 2%)INACTIVE INGREDIENTHB1401PQFSHYPERPIGMENTATION TREATMENT (HYDROQUINONE) LOTION [SKIN AUTHORITY LLC]1
SODIUM BISULFITEINACTIVE INGREDIENTTZX5469Z6IHYPERPIGMENTATION TREATMENT (HYDROQUINONE) LOTION [SKIN AUTHORITY LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IHYPERPIGMENTATION TREATMENT (HYDROQUINONE) LOTION [SKIN AUTHORITY LLC]1
SODIUM SULFITEINACTIVE INGREDIENTVTK01UQK3GHYPERPIGMENTATION TREATMENT (HYDROQUINONE) LOTION [SKIN AUTHORITY LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RHYPERPIGMENTATION TREATMENT (HYDROQUINONE) LOTION [SKIN AUTHORITY LLC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46007-301-124600703011250 mL in 1 BOTTLE (46007-301-12) 50 ml2012-04-190000-00-00NoNoCurrent