Home NDC 68828-010 JAFRA Fruteria Coco Fresco Lip Balm
Product NDC 68828-010
11-digit product format 688280010
Labeler code 68828
Product ID 68828-010_41ad5581-5b88-1c8b-e063-6294a90a2ba6
Type HUMAN OTC DRUG
Nonproprietary name DIMETHICONE
Dosage form GEL
Route TOPICAL
Labeler Distribuidora Comercial Jafra, S.A. de C.V.
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-06-01
Substance DIMETHICONE
Active strength 1 g/100mL
Pharmacologic classes Skin Barrier Activity [PE]
NDC exclude flag No
Listing certified through 2026-12-31
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 JAFRA Fruteria Coco Fresco Lip Balm
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 1 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 92RU3N3Y1O Internal UNII lookup
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 68828-010-01 JAFRA Fruteria Coco Fresco Lip Balm 1 in 1 CARTON GEL 1 3 68828-010-01 JAFRA Fruteria Coco Fresco Lip Balm 15 mL in 1 TUBE GEL 15 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68828-010 JAFRA FRUTERIA COCO FRESCO LIP BALM (DIMETHICONE) GEL [DISTRIBUIDORA COMERCIAL JAFRA, S.A. DE C.V.] 2 Current NDC, 2 package rows 20241228_9895a320-8a74-4b27-9bf1-4b492f89888c.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 39 of 68 · 1,357 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68828-010-01 68828001001 1 TUBE in 1 CARTON (68828-010-01) / 15 mL in 1 TUBE 1 tube 2023-06-01 No No Current