Home NDC 71564-001 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 Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base OKeeffes Lip Repair
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 2.5 g/100g DIMETHICONE 17.5 g/100g OCTINOXATE 6 g/100g OCTOCRYLENE 2 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71564-001-42 OKeeffes Lip Repair 4.2 g in 1 CYLINDER STICK 4.2 5 71564-001-42 OKeeffes Lip Repair 1 in 1 BLISTER PACK STICK 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71564-001 OKEEFFES LIP REPAIR (AVOBENZONE, DIMETHICONE, OCTINOXATE, OCTOCRYLENE) STICK [THE GORILLA GLUE COMPANY/O'KEEFFE'S COMPANY] 4 Current NDC, Legacy NDC, 2 package rows 20240110_6805b3e9-77cb-bfee-e053-2991aa0a8d98.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 26 of 354 · 7,077 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71564-001-42 71564000142 1 CYLINDER in 1 BLISTER PACK (71564-001-42) / 4.2 g in 1 CYLINDER 1 cylinder 2018-03-22 0000-00-00 No No Current