Home NDC 65278-110 Rapid Repair Healing Cream
Product NDC 65278-110
11-digit product format 652780110
Labeler code 65278
Product ID 65278-110_4bba33c0-e465-fe3e-e063-6394a90aadfb
Type HUMAN OTC DRUG
Nonproprietary name Allantoin, Dimethicone
Dosage form CREAM
Route TOPICAL
Labeler June Jacobs Labs LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2011-11-09
Substance ALLANTOIN; DIMETHICONE
Active strength .9907; 2.9721 g/198.14g; g/198.14g
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 Rapid Repair Healing Cream
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALLANTOIN .9907 g/198.14g DIMETHICONE 2.9721 g/198.14g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 344S277G0Z Internal UNII lookup 92RU3N3Y1O Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65278-110-01 Rapid Repair Healing Cream 198.14 g in 1 TUBE CREAM 198.14 2 65278-110-02 Rapid Repair Healing Cream 198.14 g in 1 CARTON CREAM 198.14 2 65278-110-03 Rapid Repair Healing Cream 112.38 g in 1 TUBE CREAM 112.38 2 65278-110-04 Rapid Repair Healing Cream 112.38 g in 1 CARTON CREAM 112.38 2 65278-110-05 Rapid Repair Healing Cream 47.32 g in 1 TUBE CREAM 47.32 2 65278-110-06 Rapid Repair Healing Cream 47.32 g in 1 CARTON CREAM 47.32 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65278-110 RAPID REPAIR HEALING CREAM (ALLANTOIN, DIMETHICONE) CREAM [JUNE JACOBS LABS LLC] 1 Current NDC, 6 package rows 20240523_186c13be-5e41-b9c9-e063-6294a90ad574.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 28 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 65278-110-01 65278011001 198.14 g in 1 TUBE (65278-110-01) 198.14 g 2011-11-09 No No Current 65278-110-02 65278011002 198.14 g in 1 CARTON (65278-110-02) 198.14 g 2011-11-09 No No Current 65278-110-03 65278011003 112.38 g in 1 TUBE (65278-110-03) 112.38 g 2011-11-09 No No Current 65278-110-04 65278011004 112.38 g in 1 CARTON (65278-110-04) 112.38 g 2011-11-09 No No Current 65278-110-05 65278011005 47.32 g in 1 TUBE (65278-110-05) 47.32 g 2011-11-09 No No Current 65278-110-06 65278011006 47.32 g in 1 CARTON (65278-110-06) 47.32 g 2011-11-09 No No Current