FDA.reportPublic FDA data

Rhofade

Product NDC
71180-003
11-digit product format
711800003
Labeler code
71180
Product ID
71180-003_05576e70-fad7-4d3e-8575-ce5ff28750a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxymetazoline Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Aclaris Therapeutics, Inc.
Application
NDA208552
Marketing category
NDA
Marketing start
2017-01-18
Marketing end
0000-00-00
Substance
OXYMETAZOLINE HYDROCHLORIDE
Active strength
1 g/100g
Pharmacologic classes
Vasoconstrictor [EPC],Vasoconstriction [PE],Increased Sympathetic Activity [PE],Imidazolines [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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
71180-003-152022-01-28C16284748780-1d6a99b39-b9a2-a426-e053-dadaa90af4c2These 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
71180-003-302022-01-28C16284748780-1d6a99b39-b9a2-a426-e053-dadaa90af4c2These 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
71180-003-352022-01-28C16284748780-1d6a99b39-b9a2-a426-e053-dadaa90af4c2These 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
71180-003-452022-01-28C16284748780-1d6a99b39-b9a2-a426-e053-dadaa90af4c2These 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
71180-003-602022-01-28C16284748780-1d6a99b39-b9a2-a426-e053-dadaa90af4c2These 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
71180-003-652022-01-28C16284748780-1d6a99b39-b9a2-a426-e053-dadaa90af4c2These 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
71180-003-15Rhofade3 g in 1 TUBECREAM33
71180-003-30Rhofade1 in 1 CARTONCREAM13
71180-003-30Rhofade30 g in 1 TUBECREAM303
71180-003-35Rhofade30 g in 1 BOTTLE, PUMPCREAM303
71180-003-35Rhofade1 in 1 CARTONCREAM13
71180-003-45Rhofade45 g in 1 TUBECREAM453
71180-003-45Rhofade1 in 1 CARTONCREAM13
71180-003-60Rhofade1 in 1 CARTONCREAM13
71180-003-60Rhofade60 g in 1 TUBECREAM603
71180-003-65Rhofade60 g in 1 BOTTLE, PUMPCREAM603
71180-003-65Rhofade1 in 1 CARTONCREAM13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71180-003-30GM - Gram71180-00335e148e9-531a-48f2-a4d3-69a6e63450ef12020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71180-003RHOFADE (OXYMETAZOLINE HYDROCHLORIDE) CREAM [ACLARIS THERAPEUTICS, INC.]3Legacy NDC, 11 package rows20191206_8968299e-2a4f-41a8-9088-6343ea6c91f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1869816oxymetazoline HCl 1 % Topical CreamPSN8968299e-2a4f-41a8-9088-6343ea6c91f43
1869821Rhofade 1 % Topical CreamPSN8968299e-2a4f-41a8-9088-6343ea6c91f43
1869821oxymetazoline hydrochloride 10 MG/ML Topical Cream [Rhofade]SBD8968299e-2a4f-41a8-9088-6343ea6c91f43
1869816oxymetazoline hydrochloride 10 MG/ML Topical CreamSCD8968299e-2a4f-41a8-9088-6343ea6c91f43
1869816oxymetazoline HCl 1 % Topical CreamSY8968299e-2a4f-41a8-9088-6343ea6c91f43
1869821Rhofade 1 % Topical CreamSY8968299e-2a4f-41a8-9088-6343ea6c91f43
1869821Rhofade 10 MG/ML Topical CreamSY8968299e-2a4f-41a8-9088-6343ea6c91f43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71180-003-15711800003153 g in 1 TUBE (71180-003-15) 3 g2017-01-180000-00-00NoNoCurrent
71180-003-30711800003301 TUBE in 1 CARTON (71180-003-30) > 30 g in 1 TUBE1 tube2017-01-180000-00-00NoNoCurrent
71180-003-35711800003351 BOTTLE, PUMP in 1 CARTON (71180-003-35) > 30 g in 1 BOTTLE, PUMP2017-01-180000-00-00NoNoCurrent
71180-003-45711800003451 TUBE in 1 CARTON (71180-003-45) > 45 g in 1 TUBE1 tube2017-01-180000-00-00NoNoCurrent
71180-003-60711800003601 TUBE in 1 CARTON (71180-003-60) > 60 g in 1 TUBE1 tube2017-01-180000-00-00NoNoCurrent
71180-003-65711800003651 BOTTLE, PUMP in 1 CARTON (71180-003-65) > 60 g in 1 BOTTLE, PUMP2017-01-180000-00-00NoNoCurrent