OKeeffes Lip Repair

Product NDC
71564-001
11-digit product format
715640001
Labeler code
71564
Product ID
71564-001_485a1a07-c826-b1c8-e063-6294a90a97c5
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Dimethicone, Octinoxate, Octocrylene
Dosage form
STICK
Route
TOPICAL
Labeler
The Gorilla Glue Company/O'Keeffe's Company
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-03-22
Substance
AVOBENZONE; DIMETHICONE; OCTINOXATE; OCTOCRYLENE
Active strength
2.5; 17.5; 6; 2 g/100g; g/100g; g/100g; g/100g
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
OKeeffes Lip Repair
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE2.5 g/100g
DIMETHICONE17.5 g/100g
OCTINOXATE6 g/100g
OCTOCRYLENE2 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG63QQF2NOX, 92RU3N3Y1O, 4Y5P7MUD51, 5A68WGF6WM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71564-001-42OKeeffes Lip Repair4.2 g in 1 CYLINDERSTICK4.25
71564-001-42OKeeffes Lip Repair1 in 1 BLISTER PACKSTICK15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71564-001OKEEFFES LIP REPAIR (AVOBENZONE, DIMETHICONE, OCTINOXATE, OCTOCRYLENE) STICK [THE GORILLA GLUE COMPANY/O'KEEFFE'S COMPANY]4Current NDC, Legacy NDC, 2 package rows20240110_6805b3e9-77cb-bfee-e053-2991aa0a8d98.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71564-001-42715640001421 CYLINDER in 1 BLISTER PACK (71564-001-42) / 4.2 g in 1 CYLINDER1 cylinder2018-03-220000-00-00NoNoCurrent