Home NDC 53218-001 Total White Brightening
Product NDC 53218-001
11-digit product format 532180001
Labeler code 53218
Product ID 53218-001_f7d78925-b307-fd57-1b8c-128808d408c6
Type HUMAN OTC DRUG
Nonproprietary name Hydroquinone, Ethylhexyl Methoxycinnamate
Dosage form LOTION
Route TOPICAL
Labeler YZY Inc
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2012-10-10
Marketing end 0000-00-00
Substance OCTINOXATE; HYDROQUINONE
Active strength 14 mg/473mL; mg/473mL
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 53218-001-01 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 53218-001-01 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 53218-001-01 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 53218-001-01 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 53218-001-01 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 53218-001-01 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 53218-001-01 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 53218-001-01 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 53218-001-01 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 53218-001-01 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 53218-001-01 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 53218-001-01 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 53218-001-01 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 53218-001-01 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 53218-001-01 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 53218-001-01 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 53218-001-01 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 53218-001-01 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 53218-001-01 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 53218-001-01 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 53218-001-01 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 53218-001-01 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 53218-001-01 Total White Brightening 473 mL in 1 BOTTLE, PLASTIC LOTION 473 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Hydroquinone ACTIVE INGREDIENT XV74C1N1AE TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) LOTION [YZY INC] 1 Octinoxate ACTIVE INGREDIENT 4Y5P7MUD51 TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) LOTION [YZY INC] 1 Hydroquinone ACTIVE MOIETY XV74C1N1AE TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) LOTION [YZY INC] 1 Octinoxate ACTIVE MOIETY 4Y5P7MUD51 TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) LOTION [YZY INC] 1 .alpha.-tocopherol Acetate INACTIVE INGREDIENT 9E8X80D2L0 TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) LOTION [YZY INC] 1 .beta.-carotene INACTIVE INGREDIENT 01YAE03M7J TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) LOTION [YZY INC] 1 Bilberry INACTIVE INGREDIENT 9P2U39H18W TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) LOTION [YZY INC] 1 Carrot Seed Oil INACTIVE INGREDIENT 595AO13F11 TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) LOTION [YZY INC] 1 Cetyl Alcohol INACTIVE INGREDIENT 936JST6JCN TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) LOTION [YZY INC] 1 Coco-caprylate/caprate INACTIVE INGREDIENT 8D9H4QU99H TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) LOTION [YZY INC] 1 Corn Oil INACTIVE INGREDIENT 8470G57WFM TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) LOTION [YZY INC] 1 Dmdm Hydantoin INACTIVE INGREDIENT BYR0546TOW TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) LOTION [YZY INC] 1 Edetate Sodium INACTIVE INGREDIENT MP1J8420LU TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) LOTION [YZY INC] 1 Glyceryl Monostearate INACTIVE INGREDIENT 230OU9XXE4 TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) LOTION [YZY INC] 1 Kojic Acid INACTIVE INGREDIENT 6K23F1TT52 TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) LOTION [YZY INC] 1 Lemon INACTIVE INGREDIENT 24RS0A988O TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) LOTION [YZY INC] 1 Methylparaben INACTIVE INGREDIENT A2I8C7HI9T TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) LOTION [YZY INC] 1 Orange INACTIVE INGREDIENT 5EVU04N5QU TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) LOTION [YZY INC] 1 Pentetic Acid INACTIVE INGREDIENT 7A314HQM0I TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) LOTION [YZY INC] 1 Polyethylene Glycol 400 INACTIVE INGREDIENT B697894SGQ TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) LOTION [YZY INC] 1 Polyethylene Glycol 4500 INACTIVE INGREDIENT TVH7653921 TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) LOTION [YZY INC] 1 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) LOTION [YZY INC] 1 Propylparaben INACTIVE INGREDIENT Z8IX2SC1OH TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) LOTION [YZY INC] 1 Sodium Metabisulfite INACTIVE INGREDIENT 4VON5FNS3C TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) LOTION [YZY INC] 1 Sodium Sulfite INACTIVE INGREDIENT VTK01UQK3G TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) LOTION [YZY INC] 1 Stearic Acid INACTIVE INGREDIENT 4ELV7Z65AP TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) LOTION [YZY INC] 1 Stearyl Stearate INACTIVE INGREDIENT 5WX2EGD0DK TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) LOTION [YZY INC] 1 Sugarcane INACTIVE INGREDIENT 81H2R5AOH3 TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) LOTION [YZY INC] 1 Vitamin A Palmitate INACTIVE INGREDIENT 1D1K0N0VVC TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) LOTION [YZY INC] 1 Water INACTIVE INGREDIENT 059QF0KO0R TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) LOTION [YZY INC] 1 Xanthan Gum INACTIVE INGREDIENT TTV12P4NEE TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) LOTION [YZY INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53218-001 TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) LOTION [YZY INC] 1 Legacy NDC, 1 package rows 20121109_89d9f2ec-5f73-e299-58b5-0a40d6fdc149.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 53218-001-01 53218000101 473 mL in 1 BOTTLE, PLASTIC 473 ml Historical