Home NDC 65113-8401 SKIN LIGHTENING COMPLEX
Product NDC 65113-8401
11-digit product format 651138401
Labeler code 65113
Product ID 65113-8401_747d192d-0a31-44b3-8dff-71cb2aa196ea
Type HUMAN OTC DRUG
Nonproprietary name HYDROQUINONE
Dosage form CREAM
Route TOPICAL
Labeler G.S. COSMECEUTICAL USA, INC.
Application part358A
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2009-12-09
Marketing end 0000-00-00
Substance HYDROQUINONE
Active strength 2 g/100g
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record 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 date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 65113-8401-1 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 65113-8401-1 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 65113-8401-1 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 65113-8401-1 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 65113-8401-1 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 65113-8401-1 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 65113-8401-1 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 65113-8401-1 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 65113-8401-1 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 65113-8401-1 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 65113-8401-1 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 65113-8401-1 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 65113-8401-1 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 65113-8401-1 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 65113-8401-1 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 65113-8401-1 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 65113-8401-1 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 65113-8401-1 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 65113-8401-1 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 65113-8401-1 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 65113-8401-1 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 65113-8401-1 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65113-8401-1 SKIN LIGHTENING COMPLEX 30 g in 1 TUBE CREAM 30 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDROQUINONE ACTIVE INGREDIENT XV74C1N1AE SKIN LIGHTENING COMPLEX (HYDROQUINONE) CREAM [G.S. COSMECEUTICAL USA, INC.] 1 PHENOL ACTIVE MOIETY 339NCG44TV SKIN LIGHTENING COMPLEX (HYDROQUINONE) CREAM [G.S. COSMECEUTICAL USA, INC.] 1 Alpha-Tocopherol Acetate INACTIVE INGREDIENT 9E8X80D2L0 SKIN LIGHTENING COMPLEX (HYDROQUINONE) CREAM [G.S. COSMECEUTICAL USA, INC.] 1 Arctostaphylos Uva-Ursi Leaf INACTIVE INGREDIENT 3M5V3D1X36 SKIN LIGHTENING COMPLEX (HYDROQUINONE) CREAM [G.S. COSMECEUTICAL USA, INC.] 1 Butylated Hydroxytoluene INACTIVE INGREDIENT 1P9D0Z171K SKIN LIGHTENING COMPLEX (HYDROQUINONE) CREAM [G.S. COSMECEUTICAL USA, INC.] 1 Butylene Glycol INACTIVE INGREDIENT 3XUS85K0RA SKIN LIGHTENING COMPLEX (HYDROQUINONE) CREAM [G.S. COSMECEUTICAL USA, INC.] 1 Butylparaben INACTIVE INGREDIENT 3QPI1U3FV8 SKIN LIGHTENING COMPLEX (HYDROQUINONE) CREAM [G.S. COSMECEUTICAL USA, INC.] 1 C12-15 Alkyl Benzoate INACTIVE INGREDIENT A9EJ3J61HQ SKIN LIGHTENING COMPLEX (HYDROQUINONE) CREAM [G.S. COSMECEUTICAL USA, INC.] 1 Cetyl Alcohol INACTIVE INGREDIENT 936JST6JCN SKIN LIGHTENING COMPLEX (HYDROQUINONE) CREAM [G.S. COSMECEUTICAL USA, INC.] 1 Diazolidinyl Urea INACTIVE INGREDIENT H5RIZ3MPW4 SKIN LIGHTENING COMPLEX (HYDROQUINONE) CREAM [G.S. COSMECEUTICAL USA, INC.] 1 Dimethicone INACTIVE INGREDIENT 92RU3N3Y1O SKIN LIGHTENING COMPLEX (HYDROQUINONE) CREAM [G.S. COSMECEUTICAL USA, INC.] 1 Edetate Disodium INACTIVE INGREDIENT 7FLD91C86K SKIN LIGHTENING COMPLEX (HYDROQUINONE) CREAM [G.S. COSMECEUTICAL USA, INC.] 1 Ethylparaben INACTIVE INGREDIENT 14255EXE39 SKIN LIGHTENING COMPLEX (HYDROQUINONE) CREAM [G.S. COSMECEUTICAL USA, INC.] 1 Glycerin INACTIVE INGREDIENT PDC6A3C0OX SKIN LIGHTENING COMPLEX (HYDROQUINONE) CREAM [G.S. COSMECEUTICAL USA, INC.] 1 Glyceryl Monostearate INACTIVE INGREDIENT 230OU9XXE4 SKIN LIGHTENING COMPLEX (HYDROQUINONE) CREAM [G.S. COSMECEUTICAL USA, INC.] 1 Glycolic Acid INACTIVE INGREDIENT 0WT12SX38S SKIN LIGHTENING COMPLEX (HYDROQUINONE) CREAM [G.S. COSMECEUTICAL USA, INC.] 1 Glycyrrhiza Glabra INACTIVE INGREDIENT 2788Z9758H SKIN LIGHTENING COMPLEX (HYDROQUINONE) CREAM [G.S. COSMECEUTICAL USA, INC.] 1 Green Tea Leaf INACTIVE INGREDIENT W2ZU1RY8B0 SKIN LIGHTENING COMPLEX (HYDROQUINONE) CREAM [G.S. COSMECEUTICAL USA, INC.] 1 Isobutylparaben INACTIVE INGREDIENT 0QQJ25X58G SKIN LIGHTENING COMPLEX (HYDROQUINONE) CREAM [G.S. COSMECEUTICAL USA, INC.] 1 Lactic Acid INACTIVE INGREDIENT 33X04XA5AT SKIN LIGHTENING COMPLEX (HYDROQUINONE) CREAM [G.S. COSMECEUTICAL USA, INC.] 1 Medium-Chain Triglycerides INACTIVE INGREDIENT C9H2L21V7U SKIN LIGHTENING COMPLEX (HYDROQUINONE) CREAM [G.S. COSMECEUTICAL USA, INC.] 1 Methylparaben INACTIVE INGREDIENT A2I8C7HI9T SKIN LIGHTENING COMPLEX (HYDROQUINONE) CREAM [G.S. COSMECEUTICAL USA, INC.] 1 Myristyl Alcohol INACTIVE INGREDIENT V42034O9PU SKIN LIGHTENING COMPLEX (HYDROQUINONE) CREAM [G.S. COSMECEUTICAL USA, INC.] 1 Phenoxyethanol INACTIVE INGREDIENT HIE492ZZ3T SKIN LIGHTENING COMPLEX (HYDROQUINONE) CREAM [G.S. COSMECEUTICAL USA, INC.] 1 Polyoxyl 100 Stearate INACTIVE INGREDIENT YD01N1999R SKIN LIGHTENING COMPLEX (HYDROQUINONE) CREAM [G.S. COSMECEUTICAL USA, INC.] 1 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 SKIN LIGHTENING COMPLEX (HYDROQUINONE) CREAM [G.S. COSMECEUTICAL USA, INC.] 1 Propylparaben INACTIVE INGREDIENT Z8IX2SC1OH SKIN LIGHTENING COMPLEX (HYDROQUINONE) CREAM [G.S. COSMECEUTICAL USA, INC.] 1 Sodium Hydroxide INACTIVE INGREDIENT 55X04QC32I SKIN LIGHTENING COMPLEX (HYDROQUINONE) CREAM [G.S. COSMECEUTICAL USA, INC.] 1 Sodium Metabisulfite INACTIVE INGREDIENT 4VON5FNS3C SKIN LIGHTENING COMPLEX (HYDROQUINONE) CREAM [G.S. COSMECEUTICAL USA, INC.] 1 Stearyl Alcohol INACTIVE INGREDIENT 2KR89I4H1Y SKIN LIGHTENING COMPLEX (HYDROQUINONE) CREAM [G.S. COSMECEUTICAL USA, INC.] 1 Water INACTIVE INGREDIENT 059QF0KO0R SKIN LIGHTENING COMPLEX (HYDROQUINONE) CREAM [G.S. COSMECEUTICAL USA, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65113-8401 SKIN LIGHTENING COMPLEX (HYDROQUINONE) CREAM [G.S. COSMECEUTICAL USA, INC.] 1 Legacy NDC, 1 package rows 20100915_8c0ab847-bca6-4e0a-acfe-07a8323aa41c.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 65113-8401-1 65113840101 30 g in 1 TUBE 30 g Historical