ZO Skin Health Pigment Control plus Brightening Creme Hydroquinone plus Vitamin C

Product NDC
42851-035
Requested package NDC
42851-035-80
11-digit product format
428510035
Labeler code
42851
Product ID
42851-035_597eee94-146e-ea9e-e063-6294a90a553e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroquinone
Dosage form
EMULSION
Route
TOPICAL
Labeler
ZO Skin Health, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2018-05-01
Substance
HYDROQUINONE
Active strength
.04 mg/mL
Pharmacologic classes
Depigmenting Activity [PE], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
ZO Skin Health Pigment Control plus Brightening Creme Hydroquinone plus Vitamin C
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROQUINONE.04 mg/mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42851-035-81ZO Skin Health Pigment Control plus Brightening Creme Hydroquinone plus Vitamin C1 in 1 CARTONEMULSION13
42851-035-81ZO Skin Health Pigment Control plus Brightening Creme Hydroquinone plus Vitamin C81 mL in 1 BOTTLE, PLASTICEMULSION813

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42851-035ZO SKIN HEALTH PIGMENT CONTROL PLUS BRIGHTENING CREME HYDROQUINONE PLUS VITAMIN C (HYDROQUINONE) EMULSION [ZO SKIN HEALTH, INC.]3Current NDC, Legacy NDC, 2 package rows20220422_d7bfa71b-ddce-437e-abf9-2837af82c54d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42851-035-80428510035801 TUBE in 1 CARTON (42851-035-80) / 80 mL in 1 TUBE1 tube2026-09-01NoNoCurrent