FDA.reportPublic FDA data

Rhofade

Product NDC
71403-003
11-digit product format
714030003
Labeler code
71403
Product ID
71403-003_d743c06d-1277-4504-803b-5752af09ba03
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXYMETAZOLINE HYDROCHLORIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
EPI Health, LLC
Application
NDA208552
Marketing category
NDA
Marketing start
2021-01-18
Substance
OXYMETAZOLINE HYDROCHLORIDE
Active strength
1 g/100g
Pharmacologic classes
Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rhofade
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYMETAZOLINE HYDROCHLORIDE1 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK89MJ0S5VY
Rxcui1869816, 1869821

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71403-003-152023-05-19C16284748780-1f386c649-c8fa-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use RHOFADE ® topical cream safely and effectively. See full prescribing information for RHOFADE ® topical cream. RHOFADE ® (oxymetazoline hydrochloride) cream, 1%, for topical use Initial U.S. Approval: 1964
71403-003-302023-05-19C16284748780-1f386c649-c8fa-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use RHOFADE ® topical cream safely and effectively. See full prescribing information for RHOFADE ® topical cream. RHOFADE ® (oxymetazoline hydrochloride) cream, 1%, for topical use Initial U.S. Approval: 1964
71403-003-152023-01-30C16284748780-1f386c649-c8fa-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use RHOFADE ® topical cream safely and effectively. See full prescribing information for RHOFADE ® topical cream. RHOFADE ® (oxymetazoline hydrochloride) cream, 1%, for topical use Initial U.S. Approval: 1964
71403-003-302023-01-30C16284748780-1f386c649-c8fa-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use RHOFADE ® topical cream safely and effectively. See full prescribing information for RHOFADE ® topical cream. RHOFADE ® (oxymetazoline hydrochloride) cream, 1%, for topical use Initial U.S. Approval: 1964

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71403-003-15Rhofade3 g in 1 TUBECREAM32
71403-003-15Rhofade1 in 1 CARTONCREAM12
71403-003-30Rhofade1 in 1 CARTONCREAM12
71403-003-30Rhofade30 g in 1 TUBECREAM302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71403-003-30GM - Gram71403-00366405208-9c3d-4021-be16-72363f9aa08d12021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71403-003RHOFADE (OXYMETAZOLINE HYDROCHLORIDE) CREAM [EPI HEALTH, LLC]2Current NDC, Legacy NDC, 4 package rows20230520_e82b5788-a855-4165-a81f-7f15cb874612.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1869816oxymetazoline HCl 1 % Topical CreamPSNe82b5788-a855-4165-a81f-7f15cb8746122
1869821Rhofade 1 % Topical CreamPSNe82b5788-a855-4165-a81f-7f15cb8746122
1869821oxymetazoline hydrochloride 10 MG/ML Topical Cream [Rhofade]SBDe82b5788-a855-4165-a81f-7f15cb8746122
1869816oxymetazoline hydrochloride 10 MG/ML Topical CreamSCDe82b5788-a855-4165-a81f-7f15cb8746122
1869816oxymetazoline HCl 1 % Topical CreamSYe82b5788-a855-4165-a81f-7f15cb8746122
1869821Rhofade 1 % Topical CreamSYe82b5788-a855-4165-a81f-7f15cb8746122
1869821Rhofade 10 MG/ML Topical CreamSYe82b5788-a855-4165-a81f-7f15cb8746122

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71403-003-15714030003151 TUBE in 1 CARTON (71403-003-15) / 3 g in 1 TUBE1 tube2021-01-180000-00-00NoNoCurrent
71403-003-30714030003301 TUBE in 1 CARTON (71403-003-30) / 30 g in 1 TUBE1 tube2021-01-180000-00-00NoNoCurrent