ZO Skin Health Pigment Control Creme Hydroquinone

Product NDC
42851-038
11-digit product format
428510038
Labeler code
42851
Product ID
42851-038_dd82a6af-aa21-98ba-e053-2995a90a5540
Type
HUMAN OTC DRUG
Nonproprietary name
Hydroquinone
Dosage form
LOTION
Route
TOPICAL
Labeler
ZO Skin Health, Inc.
Application
part358A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2018-11-07
Marketing end
0000-00-00
Substance
HYDROQUINONE
Active strength
20 mg/mL
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

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42851-038-802025-01-30C16284748780-12cef2736-6aa8-d83d-e063-dadaa90ab31fZO ® Skin Health Pigment Control Creme 2% Hydroquinone National Drug Code 42851-038-80

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42851-038-80ZO Skin Health Pigment Control Creme Hydroquinone1 in 1 CARTONLOTION12
42851-038-80ZO Skin Health Pigment Control Creme Hydroquinone80 mL in 1 BOTTLE, PLASTICLOTION802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42851-038ZO SKIN HEALTH PIGMENT CONTROL CREME HYDROQUINONE (HYDROQUINONE) LOTION [ZO SKIN HEALTH, INC.]2Legacy NDC, 2 package rows20220426_d9285ffa-6114-4798-9b16-169d2bb67355.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
244594hydroquinone 2 % Topical LotionPSNd9285ffa-6114-4798-9b16-169d2bb673552
244594hydroquinone 20 MG/ML Topical LotionSCDd9285ffa-6114-4798-9b16-169d2bb673552
244594hydroquinone 2 % Topical LotionSYd9285ffa-6114-4798-9b16-169d2bb673552

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42851-038-80428510038801 BOTTLE, PLASTIC in 1 CARTON (42851-038-80) > 80 mL in 1 BOTTLE, PLASTIC2018-11-070000-00-00NoNoCurrent