Total White Brightening

Product NDC: 53218-002
11-digit product format: 532180002
Labeler code: 53218
Product ID: 53218-002_a1adbdb7-d742-222d-dd33-1d274a198ec1
Type: HUMAN OTC DRUG
Nonproprietary name: Hydroquinone, Ethylhexyl Methoxycinnamate
Dosage form: CREAM
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: 3 g/100g; g/100g
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53218-002		I	Inactivated by FDA	2026-10-15
excluded package	package	53218-002	53218-002-02	I	Inactivated by FDA	2026-10-15
excluded package	package	53218-002	53218-002-03	I	Inactivated by FDA	2026-10-15
excluded package	package	53218-002	53218-002-04	I	Inactivated by FDA	2026-10-15

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 2 · 88 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	53218-002-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53218-002-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53218-002-02	`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	53218-002-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53218-002-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53218-002-02	`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	53218-002-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53218-002-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53218-002-02	`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	53218-002-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53218-002-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53218-002-02	`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	53218-002-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53218-002-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53218-002-02	`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	53218-002-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53218-002-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53218-002-02	`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	53218-002-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53218-002-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53218-002-02	`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	53218-002-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53218-002-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53218-002-02	`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	53218-002-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53218-002-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53218-002-02	`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	53218-002-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53218-002-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53218-002-02	`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	53218-002-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53218-002-04	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53218-002-02	`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	53218-002-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53218-002-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53218-002-02	`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	53218-002-03	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53218-002-04	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53218-002-02	`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	53218-002-03	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53218-002-04	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53218-002-02	`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	53218-002-03	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53218-002-04	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53218-002-02	`1332a3947898…`	`d4bfe170f9cd…`

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 concept	Relation	Version	Effective
85490a6b-2306-6bf2-c51b-eb63537dc2da	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53218-002-02	2019-11-27	C162847	48780-1	9855d018-d86e-cd31-e053-dbdaa90ab51a	Drug Facts
53218-002-03	2019-11-27	C162847	48780-1	9855d018-d86e-cd31-e053-dbdaa90ab51a	Drug Facts
53218-002-04	2019-11-27	C162847	48780-1	9855d018-d86e-cd31-e053-dbdaa90ab51a	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53218-002-02	Total White Brightening	227 g in 1 JAR	CREAM	227	1
53218-002-03	Total White Brightening	454 g in 1 JAR	CREAM	454	1
53218-002-04	Total White Brightening	50 g in 1 TUBE	CREAM	50	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Hydroquinone	ACTIVE INGREDIENT	XV74C1N1AE	TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) CREAM [YZY INC]	1
Octinoxate	ACTIVE INGREDIENT	4Y5P7MUD51	TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) CREAM [YZY INC]	1
Hydroquinone	ACTIVE MOIETY	XV74C1N1AE	TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) CREAM [YZY INC]	1
Octinoxate	ACTIVE MOIETY	4Y5P7MUD51	TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) CREAM [YZY INC]	1
.alpha.-tocopherol Acetate	INACTIVE INGREDIENT	9E8X80D2L0	TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) CREAM [YZY INC]	1
.beta.-carotene	INACTIVE INGREDIENT	01YAE03M7J	TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) CREAM [YZY INC]	1
Bilberry	INACTIVE INGREDIENT	9P2U39H18W	TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) CREAM [YZY INC]	1
Carrot Seed Oil	INACTIVE INGREDIENT	595AO13F11	TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) CREAM [YZY INC]	1
Cetyl Alcohol	INACTIVE INGREDIENT	936JST6JCN	TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) CREAM [YZY INC]	1
Coco-caprylate/caprate	INACTIVE INGREDIENT	8D9H4QU99H	TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) CREAM [YZY INC]	1
Corn Oil	INACTIVE INGREDIENT	8470G57WFM	TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) CREAM [YZY INC]	1
Dmdm Hydantoin	INACTIVE INGREDIENT	BYR0546TOW	TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) CREAM [YZY INC]	1
Edetate Sodium	INACTIVE INGREDIENT	MP1J8420LU	TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) CREAM [YZY INC]	1
Glyceryl Monostearate	INACTIVE INGREDIENT	230OU9XXE4	TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) CREAM [YZY INC]	1
Kojic Acid	INACTIVE INGREDIENT	6K23F1TT52	TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) CREAM [YZY INC]	1
Lemon	INACTIVE INGREDIENT	24RS0A988O	TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) CREAM [YZY INC]	1
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) CREAM [YZY INC]	1
Orange	INACTIVE INGREDIENT	5EVU04N5QU	TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) CREAM [YZY INC]	1
Pentetic Acid	INACTIVE INGREDIENT	7A314HQM0I	TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) CREAM [YZY INC]	1
Polyethylene Glycol 400	INACTIVE INGREDIENT	B697894SGQ	TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) CREAM [YZY INC]	1
Polyethylene Glycol 4500	INACTIVE INGREDIENT	TVH7653921	TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) CREAM [YZY INC]	1
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) CREAM [YZY INC]	1
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) CREAM [YZY INC]	1
Sodium Metabisulfite	INACTIVE INGREDIENT	4VON5FNS3C	TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) CREAM [YZY INC]	1
Sodium Sulfite	INACTIVE INGREDIENT	VTK01UQK3G	TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) CREAM [YZY INC]	1
Stearic Acid	INACTIVE INGREDIENT	4ELV7Z65AP	TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) CREAM [YZY INC]	1
Stearyl Stearate	INACTIVE INGREDIENT	5WX2EGD0DK	TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) CREAM [YZY INC]	1
Sugarcane	INACTIVE INGREDIENT	81H2R5AOH3	TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) CREAM [YZY INC]	1
Vitamin A Palmitate	INACTIVE INGREDIENT	1D1K0N0VVC	TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) CREAM [YZY INC]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) CREAM [YZY INC]	1
Xanthan Gum	INACTIVE INGREDIENT	TTV12P4NEE	TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) CREAM [YZY INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53218-002	TOTAL WHITE BRIGHTENING (HYDROQUINONE, ETHYLHEXYL METHOXYCINNAMATE) CREAM [YZY INC]	1	Legacy NDC, 3 package rows	20121109_52912284-80b3-c079-d02c-ea62cf164c3e.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
XV74C1N1AE	HYDROQUINONE	123-31-9	HYDROQUINONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
153031	hydroquinone 2 % Topical Cream	PSN	52912284-80b3-c079-d02c-ea62cf164c3e	1
153031	hydroquinone 20 MG/ML Topical Cream	SCD	52912284-80b3-c079-d02c-ea62cf164c3e	1
153031	hydroquinone 2 % Topical Cream	SY	52912284-80b3-c079-d02c-ea62cf164c3e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
53218-002-02	53218000202	227 g in 1 JAR	227 g	Historical
53218-002-03	53218000203	454 g in 1 JAR	454 g	Historical
53218-002-04	53218000204	50 g in 1 TUBE	50 g	Historical