Topiclear Xtra beauty

Product NDC: 66129-028
11-digit product format: 661290028
Labeler code: 66129
Product ID: 66129-028_207152a7-4ca6-4dbe-b2c4-c1cafb1f6ab4
Type: HUMAN OTC DRUG
Nonproprietary name: HYDROQUINONE
Dosage form: LOTION
Route: TOPICAL
Labeler: International Beauty Exchange
Application: part358A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2011-01-01
Marketing end: 0000-00-00
Substance: HYDROQUINONE; OCTINOXATE
Active strength: 10 mL/500mL; mL/500mL
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	66129-028		I	Inactivated by FDA		2026-08-17
excluded package	package	66129-028	66129-028-25	I	Inactivated by FDA		2026-08-17

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 · 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	66129-028-25	`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	66129-028-25	`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	66129-028-25	`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	66129-028-25	`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	66129-028-25	`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	66129-028-25	`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	66129-028-25	`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	66129-028-25	`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	66129-028-25	`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	66129-028-25	`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	66129-028-25	`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	66129-028-25	`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	66129-028-25	`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	66129-028-25	`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	66129-028-25	`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	66129-028-25	`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	66129-028-25	`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	66129-028-25	`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	66129-028-25	`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	66129-028-25	`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	66129-028-25	`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	66129-028-25	`110d247fa046…`	`a55b01930146…`

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
66129-028-25	2019-10-29	C162847	48780-1	960f7f55-c2a5-8e05-e053-dbdaa90a074a	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66129-028-25	Topiclear Xtra beauty	500 mL in 1 BOTTLE	LOTION	500		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROQUINONE	ACTIVE INGREDIENT	XV74C1N1AE	TOPICLEAR XTRA BEAUTY (HYDROQUINONE) LOTION [INTERNATIONAL BEAUTY EXCHANGE]	1
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	TOPICLEAR XTRA BEAUTY (HYDROQUINONE) LOTION [INTERNATIONAL BEAUTY EXCHANGE]	1
HYDROQUINONE	ACTIVE MOIETY	XV74C1N1AE	TOPICLEAR XTRA BEAUTY (HYDROQUINONE) LOTION [INTERNATIONAL BEAUTY EXCHANGE]	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	TOPICLEAR XTRA BEAUTY (HYDROQUINONE) LOTION [INTERNATIONAL BEAUTY EXCHANGE]	1
.ALPHA.-TOCOPHEROL ACETATE, D-	INACTIVE INGREDIENT	A7E6112E4N	TOPICLEAR XTRA BEAUTY (HYDROQUINONE) LOTION [INTERNATIONAL BEAUTY EXCHANGE]	1
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	TOPICLEAR XTRA BEAUTY (HYDROQUINONE) LOTION [INTERNATIONAL BEAUTY EXCHANGE]	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	TOPICLEAR XTRA BEAUTY (HYDROQUINONE) LOTION [INTERNATIONAL BEAUTY EXCHANGE]	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	TOPICLEAR XTRA BEAUTY (HYDROQUINONE) LOTION [INTERNATIONAL BEAUTY EXCHANGE]	1
CHLOROCRESOL	INACTIVE INGREDIENT	36W53O7109	TOPICLEAR XTRA BEAUTY (HYDROQUINONE) LOTION [INTERNATIONAL BEAUTY EXCHANGE]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	TOPICLEAR XTRA BEAUTY (HYDROQUINONE) LOTION [INTERNATIONAL BEAUTY EXCHANGE]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	TOPICLEAR XTRA BEAUTY (HYDROQUINONE) LOTION [INTERNATIONAL BEAUTY EXCHANGE]	1
GLYCERYL STEARATE CITRATE	INACTIVE INGREDIENT	WH8T92A065	TOPICLEAR XTRA BEAUTY (HYDROQUINONE) LOTION [INTERNATIONAL BEAUTY EXCHANGE]	1
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	TOPICLEAR XTRA BEAUTY (HYDROQUINONE) LOTION [INTERNATIONAL BEAUTY EXCHANGE]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	TOPICLEAR XTRA BEAUTY (HYDROQUINONE) LOTION [INTERNATIONAL BEAUTY EXCHANGE]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	TOPICLEAR XTRA BEAUTY (HYDROQUINONE) LOTION [INTERNATIONAL BEAUTY EXCHANGE]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TOPICLEAR XTRA BEAUTY (HYDROQUINONE) LOTION [INTERNATIONAL BEAUTY EXCHANGE]	1
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	TOPICLEAR XTRA BEAUTY (HYDROQUINONE) LOTION [INTERNATIONAL BEAUTY EXCHANGE]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	TOPICLEAR XTRA BEAUTY (HYDROQUINONE) LOTION [INTERNATIONAL BEAUTY EXCHANGE]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66129-028	TOPICLEAR XTRA BEAUTY (HYDROQUINONE) LOTION [INTERNATIONAL BEAUTY EXCHANGE]	1	Legacy NDC, 1 package rows	20110608_ef1bab45-e1fa-4160-bd76-48e4bf73722f.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
244594	hydroquinone 2 % Topical Lotion	PSN	ef1bab45-e1fa-4160-bd76-48e4bf73722f	1
244594	hydroquinone 20 MG/ML Topical Lotion	SCD	ef1bab45-e1fa-4160-bd76-48e4bf73722f	1
244594	hydroquinone 2 % Topical Lotion	SY	ef1bab45-e1fa-4160-bd76-48e4bf73722f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
66129-028-25	66129002825	500 mL in 1 BOTTLE	500 ml	Historical