Ultra Glow Fade

Product NDC: 58318-003
11-digit product format: 583180003
Labeler code: 58318
Product ID: 58318-003_626f5f92-05e4-5924-e053-2a91aa0ac58c
Type: HUMAN OTC DRUG
Nonproprietary name: Hydroquinone
Dosage form: CREAM
Route: TOPICAL
Labeler: Keystone Laboratories
Application: part358A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2018-01-10
Marketing end: 0000-00-00
Substance: HYDROQUINONE
Active strength: 1 g/51g
NDC exclude flag: No
Listing certified through: 2019-12-31
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	58318-003		I	Inactivated by FDA		2026-08-17
excluded package	package	58318-003	58318-003-01	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 · 42 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	58318-003-01	`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	58318-003-01	`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	58318-003-01	`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	58318-003-01	`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	58318-003-01	`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	58318-003-01	`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	58318-003-01	`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	58318-003-01	`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	58318-003-01	`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	58318-003-01	`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	58318-003-01	`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	58318-003-01	`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	58318-003-01	`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	58318-003-01	`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	58318-003-01	`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	58318-003-01	`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	58318-003-01	`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	58318-003-01	`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	58318-003-01	`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	58318-003-01	`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	58318-003-01	`9bebd1f3094a…`	`5416666fcb17…`

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
58318-003-01	2020-01-31	C162847	48780-1	9d75b9d0-42d6-f424-e053-dadaa90a57ce	2557b4dc-2e85-4611-afed-c299f4ed3bbf

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58318-003-01	Ultra Glow Fade	51 g in 1 CANISTER	CREAM	51		5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROQUINONE	ACTIVE INGREDIENT	XV74C1N1AE	ULTRA GLOW FADE (HYDROQUINONE) CREAM [KEYSTONE LABORATORIES]	2
HYDROQUINONE	ACTIVE MOIETY	XV74C1N1AE	ULTRA GLOW FADE (HYDROQUINONE) CREAM [KEYSTONE LABORATORIES]	2
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	ULTRA GLOW FADE (HYDROQUINONE) CREAM [KEYSTONE LABORATORIES]	2
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	ULTRA GLOW FADE (HYDROQUINONE) CREAM [KEYSTONE LABORATORIES]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	ULTRA GLOW FADE (HYDROQUINONE) CREAM [KEYSTONE LABORATORIES]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	ULTRA GLOW FADE (HYDROQUINONE) CREAM [KEYSTONE LABORATORIES]	2
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	ULTRA GLOW FADE (HYDROQUINONE) CREAM [KEYSTONE LABORATORIES]	2
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	ULTRA GLOW FADE (HYDROQUINONE) CREAM [KEYSTONE LABORATORIES]	2
METHYL ALCOHOL	INACTIVE INGREDIENT	Y4S76JWI15	ULTRA GLOW FADE (HYDROQUINONE) CREAM [KEYSTONE LABORATORIES]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	ULTRA GLOW FADE (HYDROQUINONE) CREAM [KEYSTONE LABORATORIES]	2
PROPYL GALLATE	INACTIVE INGREDIENT	8D4SNN7V92	ULTRA GLOW FADE (HYDROQUINONE) CREAM [KEYSTONE LABORATORIES]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ULTRA GLOW FADE (HYDROQUINONE) CREAM [KEYSTONE LABORATORIES]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	ULTRA GLOW FADE (HYDROQUINONE) CREAM [KEYSTONE LABORATORIES]	2
SODIUM DITHIONATE	INACTIVE INGREDIENT	RPF7Z41GAW	ULTRA GLOW FADE (HYDROQUINONE) CREAM [KEYSTONE LABORATORIES]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ULTRA GLOW FADE (HYDROQUINONE) CREAM [KEYSTONE LABORATORIES]	2
SODIUM SULFITE	INACTIVE INGREDIENT	VTK01UQK3G	ULTRA GLOW FADE (HYDROQUINONE) CREAM [KEYSTONE LABORATORIES]	2
STEARETH-20	INACTIVE INGREDIENT	L0Q8IK9E08	ULTRA GLOW FADE (HYDROQUINONE) CREAM [KEYSTONE LABORATORIES]	2
STEARYL STEARATE	INACTIVE INGREDIENT	5WX2EGD0DK	ULTRA GLOW FADE (HYDROQUINONE) CREAM [KEYSTONE LABORATORIES]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	ULTRA GLOW FADE (HYDROQUINONE) CREAM [KEYSTONE LABORATORIES]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58318-003	ULTRA GLOW FADE (HYDROQUINONE) CREAM [KEYSTONE LABORATORIES]	5	Legacy NDC, 1 package rows	20180111_2557b4dc-2e85-4611-afed-c299f4ed3bbf.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
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	2557b4dc-2e85-4611-afed-c299f4ed3bbf	5
153031	hydroquinone 20 MG/ML Topical Cream	SCD	2557b4dc-2e85-4611-afed-c299f4ed3bbf	5
153031	hydroquinone 2 % Topical Cream	SY	2557b4dc-2e85-4611-afed-c299f4ed3bbf	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
58318-003-01	58318000301	51 g in 1 CANISTER	51 g	Historical