FDA.reportPublic FDA data

ZO Skin Health Pigment Control Creme Hydroquinone

Product NDC
42851-037
11-digit product format
428510037
Labeler code
42851
Product ID
42851-037_dd47af61-3b0f-4e58-e053-2995a90a7d9c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroquinone
Dosage form
EMULSION
Route
TOPICAL
Labeler
ZO Skin Health, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2018-04-15
Substance
HYDROQUINONE
Active strength
40 mg/mL
Pharmacologic classes
Depigmenting Activity [PE], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ZO Skin Health Pigment Control Creme Hydroquinone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROQUINONE40 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
XV74C1N1AEInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1235391Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
83e34a75-d20c-43ab-be31-f8fcafec46d0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42851-037-30ZO Skin Health Pigment Control Creme Hydroquinone30 mL in 1 BOTTLE, PLASTICEMULSION304
42851-037-30ZO Skin Health Pigment Control Creme Hydroquinone1 in 1 CARTONEMULSION14
42851-037-80ZO Skin Health Pigment Control Creme Hydroquinone80 mL in 1 BOTTLE, PLASTICEMULSION804
42851-037-80ZO Skin Health Pigment Control Creme Hydroquinone1 in 1 CARTONEMULSION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42851-037ZO SKIN HEALTH PIGMENT CONTROL CREME HYDROQUINONE (HYDROQUINONE) EMULSION [ZO SKIN HEALTH, INC.]4Current NDC, Legacy NDC, 4 package rows20220423_83e34a75-d20c-43ab-be31-f8fcafec46d0.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZO Skin Health Pigment Control Creme HydroquinoneHYDROQUINONEZO Skin Health, Inc.83e34a75-d20c-43ab-be31-f8fcafec46d02022-04-22WarningsExact identifier
ndc (product): 42851-037

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1235391hydroquinone 4 % Topical LotionPSN377e151e-ee50-4488-9cc9-3169794e385e6
1235391hydroquinone 40 MG/ML Topical LotionSCD377e151e-ee50-4488-9cc9-3169794e385e6
1235391hydroquinone 4 % Topical EmulsionSY377e151e-ee50-4488-9cc9-3169794e385e6
1235391hydroquinone 4 % Topical LotionSY377e151e-ee50-4488-9cc9-3169794e385e6
1235391hydroquinone 4 % Topical LotionPSN83e34a75-d20c-43ab-be31-f8fcafec46d04
1235391hydroquinone 40 MG/ML Topical LotionSCD83e34a75-d20c-43ab-be31-f8fcafec46d04
1235391hydroquinone 4 % Topical EmulsionSY83e34a75-d20c-43ab-be31-f8fcafec46d04
1235391hydroquinone 4 % Topical LotionSY83e34a75-d20c-43ab-be31-f8fcafec46d04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42851-037-30428510037301 BOTTLE, PLASTIC in 1 CARTON (42851-037-30) / 30 mL in 1 BOTTLE, PLASTIC2018-07-010000-00-00NoNoCurrent
42851-037-80428510037801 BOTTLE, PLASTIC in 1 CARTON (42851-037-80) / 80 mL in 1 BOTTLE, PLASTIC2018-04-150000-00-00NoNoCurrent