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 65 of 68 · 1,350 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join GNP Witch Hazel WITCH HAZEL Amerisource Bergen 45ac839d-215d-4c5f-8ae5-5e111d170061 2023-12-14 Warnings Exact identifier application number: M016 La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 Skin Protectant GLYCERIN L'Oreal USA Products Inc 32eaaaab-41bd-4efe-a71d-92e3a702c1e5 2023-12-11 Warnings Exact identifier application number: M016 La Roche Posay Laboratoire Dermatologique Lipikar Eczema Relief OATMEAL COSMETIQUE ACTIVE PRODUCTION e555de17-9b42-4125-a17b-467bc1d179d7 2023-12-11 Warnings Exact identifier application number: M016 La Roche Posay Laboratoire Dermatologique Lipikar Eczema Soothing Relief OATMEAL L'Oreal USA Products Inc f7b71606-0044-4729-82e8-4514331806a0 2023-12-11 Warnings Exact identifier application number: M016 La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 GLYCERIN Cosmetique Active Production 01c8a0d5-bcd1-4639-be45-530a226401f0 2023-12-11 Warnings Exact identifier application number: M016 Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15 CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. 0bc6812a-5c2a-7bb9-e063-6294a90a36e3 2023-12-05 Warnings Exact identifier application number: M016 Carmex Classic Lip Balm Medicated Free Strawberry Stick Sunscreen SPF 15 CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. 34fae56e-367d-4659-af2d-1c9ddaf1639c 2023-12-05 Warnings Exact identifier application number: M016 Diaper Rash Cream 2.5oz ZINC OXIDE Rejoice International Corp. 0ba98cdf-489e-dc2a-e063-6294a90adb38 2023-12-04 Warnings Exact identifier application number: M016 Diaper Rash Cream 2.5oz ZINC OXIDE China Ningbo Shangge Cosmetics Technology Corp. 0baa8a14-8655-d77c-e063-6294a90ab8aa 2023-12-04 Warnings Exact identifier application number: M016 THERAPLEX Eczema Therapy OATMEAL THERAPLEX, LLC 86472a3d-7138-4141-8422-ab20c17a46e0 2023-12-04 Warnings Exact identifier application number: M016 SOOTHE Moisturizing Rescue Cream OATMEAL Rodan & Fields 91163267-c2aa-47b3-b290-d1605536d806 2023-12-04 Warnings Exact identifier application number: M016 Manzatin-E Diaper Rash Skin Protectant ZINC OXIDE Laboratorios Zepol S.A. cafd084f-8493-4d6e-b256-2d4b4282f866 2023-12-01 Warnings Exact identifier application number: M016 Manzatin Diaper Rash Skin Protectant ZINC OXIDE Laboratorios Zepol S.A. 5c1618a4-ca08-4814-a556-74e79db618b9 2023-12-01 Warnings Exact identifier application number: M016 Petrolatum Jelly PETROLATUM NEW PRIDE CORP f6634410-fa1f-7987-e053-2995a90abb06 2023-12-01 Warnings Exact identifier application number: M016 Cetaphil Cracked Skin Repair Balm DIMETHICONE Galderma Laboratories, L.P. 5efb3ef0-6ee9-4ef8-b81e-90bd1825c956 2023-11-30 Warnings Exact identifier application number: M016 Cetaphil Cracked Skin Repair DIMETHICONE Galderma Laboratories, L.P. 27d74e0f-8359-4c59-bf7f-acade7f4545c 2023-11-30 Warnings Exact identifier application number: M016 Sheffield Advanced Scar Gel ADVANCED SCAR GEL Sheffield Pharmaceuticals LLC ab78b946-81ed-442c-a167-26c26c7fe8a1 2023-11-30 Warnings Exact identifier application number: M016 Akin Diaper Rash ZINC OXIDE Southern Sales & Service, Inc. f5515517-7977-48f9-aab6-cf0d2f2a04a0 2023-11-29 Warnings Exact identifier application number: M016 Dr. Sheffield Diaper Rash ZINC OXIDE Sheffield Pharmaceuticals LLC cac77320-b5cf-4edf-9693-ebabfb61390c 2023-11-28 Warnings Exact identifier application number: M016 Sheffield Zinc Oxide ZINC OXIDE Sheffield Pharmaceuticals LLC 60b54c04-4387-4954-951d-165809947310 2023-11-28 Warnings Exact identifier application number: M016
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