FDA.reportPublic FDA data

EVEN KEEL RESURFACING PEEL

Product NDC
84234-000
11-digit product format
842340000
Labeler code
84234
Product ID
84234-000_523df9f6-e3b4-f63e-e063-6394a90ab29f
Type
HUMAN OTC DRUG
Nonproprietary name
SALICYLIC ACID
Dosage form
GEL
Route
TOPICAL
Labeler
Personal Day Inc.
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-11-22
Substance
SALICYLIC ACID
Active strength
10.5 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
EVEN KEEL RESURFACING PEEL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID10.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO414PZ4LPZ

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
84234-000-002026-01-29C16284748780-149896155-b011-586f-e063-e6dba90add90EVEN KEEL RESURFACING PEEL
84234-000-012026-01-29C16284748780-149896155-b011-586f-e063-e6dba90add90EVEN KEEL RESURFACING PEEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84234-000-00EVEN KEEL RESURFACING PEEL34.9 mL in 1 JARGEL34.95
84234-000-00EVEN KEEL RESURFACING PEEL1 in 1 CARTONGEL15
84234-000-01EVEN KEEL RESURFACING PEEL14.4 mL in 1 JARGEL14.45
84234-000-01EVEN KEEL RESURFACING PEEL1 in 1 CARTONGEL15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84234-000EVEN KEEL RESURFACING PEEL (SALICYLIC ACID) GEL [PERSONAL DAY INC.]4Current NDC, 4 package rows20241211_330dd564-ebac-46f0-8c2a-34bbf60887d1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84234-000-00842340000001 JAR in 1 CARTON (84234-000-00) / 34.9 mL in 1 JAR1 jar2024-11-22NoNoHistorical
84234-000-01842340000011 JAR in 1 CARTON (84234-000-01) / 14.4 mL in 1 JAR1 jar2024-11-22NoNoHistorical