HYDROQUINONE 4%

Product NDC: 68071-2748
Requested package NDC: 68071-2748-8
11-digit product format: 680712748
Labeler code: 68071
Product ID: 68071-2748_e07e3eb8-e883-8aaa-e053-2a95a90ab0f0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroquinone
Dosage form: CREAM
Route: TOPICAL
Labeler: NuCare Pharmaceuticals,Inc.
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2014-09-10
Marketing end: 0000-00-00
Substance: HYDROQUINONE
Active strength: 40 mg/g
Pharmacologic classes: Depigmenting Activity [PE], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68071-2748	68071-2748-8	I	Inactivated by FDA		2026-10-05

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 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
68071-2748-8	2025-01-30	C162847	48780-1	2cef2736-acad-d83d-e063-dadaa90ab31f	HYDROQUINONE 4% CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2748-8	HYDROQUINONE 4%	28.35 g in 1 TUBE	CREAM	28.35		1
68071-2748-8	HYDROQUINONE 4%	1 in 1 CARTON	CREAM	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2748	HYDROQUINONE 4% (HYDROQUINONE) CREAM [NUCARE PHARMACEUTICALS,INC.]	1	Legacy NDC, 2 package rows	20220603_e07e4206-4231-285d-e053-2995a90af37a.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
197795	hydroquinone 4 % Topical Cream	PSN	e07e4206-4231-285d-e053-2995a90af37a	1
197795	hydroquinone 40 MG/ML Topical Cream	SCD	e07e4206-4231-285d-e053-2995a90af37a	1
197795	hydroquinone 4 % Topical Cream	SY	e07e4206-4231-285d-e053-2995a90af37a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2748-8	68071274808	1 TUBE in 1 CARTON (68071-2748-8) > 28.35 g in 1 TUBE	1 tube	2022-06-02	0000-00-00	No	No	Current