HYDROQUINONE 4%

Product NDC
71399-0400
11-digit product format
713990400
Labeler code
71399
Product ID
71399-0400_f940dc72-b1bf-4234-944d-71c83f5e878d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroquinone
Dosage form
CREAM
Route
TOPICAL
Labeler
Akron Pharma Inc
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-09-13
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
HYDROQUINONE 4%
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROQUINONE40 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiXV74C1N1AE
Rxcui197795

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
71399-0400-12024-09-25C16284748780-1f386c649-cdf5-0266-e053-dadaa90a7c1aHYDROQUINONE 4% CREAM
71399-0400-12023-01-30C16284748780-1f386c649-cdf5-0266-e053-dadaa90a7c1aHYDROQUINONE 4% CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-0400-1HYDROQUINONE 4%28.35 g in 1 TUBECREAM28.355

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-0400-1GM - Gram71399-040075f1031d-30b0-4361-bcf6-519cfa0cf06a12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-0400HYDROQUINONE 4% (HYDROQUINONE) CREAM [AKRON PHARMA INC]5Current NDC, Legacy NDC, 1 package rows20240927_cbec45c9-4adb-4473-8c09-b1217d0f8ebc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197795hydroquinone 4 % Topical CreamPSNcbec45c9-4adb-4473-8c09-b1217d0f8ebc5
197795hydroquinone 40 MG/ML Topical CreamSCDcbec45c9-4adb-4473-8c09-b1217d0f8ebc5
197795hydroquinone 4 % Topical CreamSYcbec45c9-4adb-4473-8c09-b1217d0f8ebc5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71399-0400-17139904000128.35 g in 1 TUBE (71399-0400-1) 28.35 g2024-09-130000-00-00NoNoCurrent