Medisilke

Product NDC: 65588-2230
11-digit product format: 655882230
Labeler code: 65588
Product ID: 65588-2230_b04435ae-1f67-4bc6-ad07-eceb51ea3d37
Type: HUMAN OTC DRUG
Nonproprietary name: HYDROQUINONE
Dosage form: CREAM
Route: TOPICAL
Labeler: New GPC, Inc.
Application: part358A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2009-12-01
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	65588-2230-3	`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	65588-2230-3	`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	65588-2230-3	`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	65588-2230-3	`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	65588-2230-3	`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	65588-2230-3	`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	65588-2230-3	`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	65588-2230-3	`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	65588-2230-3	`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	65588-2230-3	`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	65588-2230-3	`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	65588-2230-3	`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	65588-2230-3	`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	65588-2230-3	`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	65588-2230-3	`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	65588-2230-3	`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	65588-2230-3	`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	65588-2230-3	`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	65588-2230-3	`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	65588-2230-3	`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	65588-2230-3	`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	65588-2230-3	`110d247fa046…`	`a55b01930146…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65588-2230-3	2019-10-29	C162847	48780-1	960f7f55-c419-8e05-e053-dbdaa90a074a	Medisilke NIGHT CREAM

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROQUINONE	ACTIVE INGREDIENT	XV74C1N1AE	MEDISILKE (HYDROQUINONE) CREAM [NEW GPC, INC.]	1
HYDROQUINONE	ACTIVE MOIETY	XV74C1N1AE	MEDISILKE (HYDROQUINONE) CREAM [NEW GPC, INC.]	1
ALPHA LIPOIC ACID	INACTIVE INGREDIENT	73Y7P0K73Y	MEDISILKE (HYDROQUINONE) CREAM [NEW GPC, INC.]	1
APPLE	INACTIVE INGREDIENT	B423VGH5S9	MEDISILKE (HYDROQUINONE) CREAM [NEW GPC, INC.]	1
BAMBUSA VULGARIS LEAF	INACTIVE INGREDIENT	EMY54R518C	MEDISILKE (HYDROQUINONE) CREAM [NEW GPC, INC.]	1
BAMBUSA VULGARIS STEM	INACTIVE INGREDIENT	SMR633LHTC	MEDISILKE (HYDROQUINONE) CREAM [NEW GPC, INC.]	1
BETA CAROTENE	INACTIVE INGREDIENT	01YAE03M7J	MEDISILKE (HYDROQUINONE) CREAM [NEW GPC, INC.]	1
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	MEDISILKE (HYDROQUINONE) CREAM [NEW GPC, INC.]	1
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	MEDISILKE (HYDROQUINONE) CREAM [NEW GPC, INC.]	1
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	MEDISILKE (HYDROQUINONE) CREAM [NEW GPC, INC.]	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	MEDISILKE (HYDROQUINONE) CREAM [NEW GPC, INC.]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	MEDISILKE (HYDROQUINONE) CREAM [NEW GPC, INC.]	1
CORN OIL	INACTIVE INGREDIENT	8470G57WFM	MEDISILKE (HYDROQUINONE) CREAM [NEW GPC, INC.]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	MEDISILKE (HYDROQUINONE) CREAM [NEW GPC, INC.]	1
DOCOSANOL	INACTIVE INGREDIENT	9G1OE216XY	MEDISILKE (HYDROQUINONE) CREAM [NEW GPC, INC.]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	MEDISILKE (HYDROQUINONE) CREAM [NEW GPC, INC.]	1
ETHYLHEXYL PALMITATE	INACTIVE INGREDIENT	2865993309	MEDISILKE (HYDROQUINONE) CREAM [NEW GPC, INC.]	1
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	MEDISILKE (HYDROQUINONE) CREAM [NEW GPC, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	MEDISILKE (HYDROQUINONE) CREAM [NEW GPC, INC.]	1
GLYCERYL STEARATE CITRATE	INACTIVE INGREDIENT	WH8T92A065	MEDISILKE (HYDROQUINONE) CREAM [NEW GPC, INC.]	1
GLYCYRRHIZA GLABRA	INACTIVE INGREDIENT	2788Z9758H	MEDISILKE (HYDROQUINONE) CREAM [NEW GPC, INC.]	1
GREEN TEA LEAF	INACTIVE INGREDIENT	W2ZU1RY8B0	MEDISILKE (HYDROQUINONE) CREAM [NEW GPC, INC.]	1
HELIANTHUS ANNUUS	INACTIVE INGREDIENT	BKJ0J3D1BP	MEDISILKE (HYDROQUINONE) CREAM [NEW GPC, INC.]	1
HEXYLENE GLYCOL	INACTIVE INGREDIENT	KEH0A3F75J	MEDISILKE (HYDROQUINONE) CREAM [NEW GPC, INC.]	1
HYALURONATE SODIUM	INACTIVE INGREDIENT	YSE9PPT4TH	MEDISILKE (HYDROQUINONE) CREAM [NEW GPC, INC.]	1
MACADAMIA OIL	INACTIVE INGREDIENT	515610SU8C	MEDISILKE (HYDROQUINONE) CREAM [NEW GPC, INC.]	1
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	MEDISILKE (HYDROQUINONE) CREAM [NEW GPC, INC.]	1
METHYLISOTHIAZOLINONE	INACTIVE INGREDIENT	229D0E1QFA	MEDISILKE (HYDROQUINONE) CREAM [NEW GPC, INC.]	1
METHYLPROPANEDIOL	INACTIVE INGREDIENT	N8F53B3R4R	MEDISILKE (HYDROQUINONE) CREAM [NEW GPC, INC.]	1
PALMITIC ACID	INACTIVE INGREDIENT	2V16EO95H1	MEDISILKE (HYDROQUINONE) CREAM [NEW GPC, INC.]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	MEDISILKE (HYDROQUINONE) CREAM [NEW GPC, INC.]	1
POLYOXYL 20 CETOSTEARYL ETHER	INACTIVE INGREDIENT	YRC528SWUY	MEDISILKE (HYDROQUINONE) CREAM [NEW GPC, INC.]	1
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	MEDISILKE (HYDROQUINONE) CREAM [NEW GPC, INC.]	1
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	MEDISILKE (HYDROQUINONE) CREAM [NEW GPC, INC.]	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	MEDISILKE (HYDROQUINONE) CREAM [NEW GPC, INC.]	1
RETINOL	INACTIVE INGREDIENT	G2SH0XKK91	MEDISILKE (HYDROQUINONE) CREAM [NEW GPC, INC.]	1
SOYBEAN	INACTIVE INGREDIENT	L7HT8F1ZOD	MEDISILKE (HYDROQUINONE) CREAM [NEW GPC, INC.]	1
SQUALANE	INACTIVE INGREDIENT	GW89575KF9	MEDISILKE (HYDROQUINONE) CREAM [NEW GPC, INC.]	1
UBIDECARENONE	INACTIVE INGREDIENT	EJ27X76M46	MEDISILKE (HYDROQUINONE) CREAM [NEW GPC, INC.]	1
VITAMIN A PALMITATE	INACTIVE INGREDIENT	1D1K0N0VVC	MEDISILKE (HYDROQUINONE) CREAM [NEW GPC, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	MEDISILKE (HYDROQUINONE) CREAM [NEW GPC, INC.]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	MEDISILKE (HYDROQUINONE) CREAM [NEW GPC, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65588-2230	MEDISILKE (HYDROQUINONE) CREAM [NEW GPC, INC.]	1	Legacy NDC	20101029_2e53471e-ad03-4d6b-9384-4af374bb5f74.zip

Medisilke

Observed NDC auxiliary status history#

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

Related DailyMed Labels#