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 50 of 68 · 1,357 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Shea Butter Petroleum Jelly PETROLATUM JELLY Walgreens e35d913e-2195-4e3d-ae38-f010317140fd 2024-12-17 Warnings Exact identifier application number: M016 Jell Pharmaceuticals Vitamin A D PETROLATUM Jell Pharmaceuticals Pvt. Ltd. 6ab8ba54-3679-4fd0-a876-cb89aace96ca 2024-12-17 Warnings Exact identifier application number: M016 Shea Butter Petroleum Jelly PETROLATUM JELLY Jell Pharmaceuticals Pvt. Ltd. cd848f33-e863-d3af-e053-2a95a90a45b1 2024-12-17 Warnings Exact identifier application number: M016 Softlips Cherry, Raspberry, Vanilla DIMETHICONE The Mentholatum Company b7b2f64e-27b4-4c71-95cf-78b37540f975 2024-12-17 Warnings Exact identifier application number: M016 Softlips Tropical Coconut DIMETHICONE The Mentholatum Company 1203ea70-dc1a-4439-a230-bd3fc45f75f5 2024-12-17 Warnings Exact identifier application number: M016 Softlips Tropical Coconut Peach Passion DIMETHICONE The Mentholatum Company 11f619e7-4a58-45e4-8f4a-fe358832ab64 2024-12-17 Warnings Exact identifier application number: M016 Softlips Watermelon, Tropical Coconut, Peach Passion DIMETHICONE The Mentholatum Company e9212502-909a-4184-905e-f31a53602c3b 2024-12-17 Warnings Exact identifier application number: M016 Softlips Watermelon DIMETHICONE The Mentholatum Company e32d738e-e0af-4f17-a753-bdc7938b1684 2024-12-17 Warnings Exact identifier application number: M016 Softlips Peach Passion DIMETHICONE The Mentholatum Company 4a133e73-e51b-4f04-91de-dc8c4d4dba30 2024-12-17 Warnings Exact identifier application number: M016 Sweet Cheeks Diaper ZINC OXIDE Tubby Todd 4ed0afe1-c893-453e-b4d5-f32561360ec1 2024-12-17 Warnings Exact identifier application number: M016 White Petrolatum PETROLATUM Geri-Care Pharmaceuticals, Corp f40a29c2-65ea-91f9-e053-2a95a90ac439 2024-12-17 Warnings Exact identifier application number: M016 Vitamin A and D PETROLATUM Geri-care Pharmaceutials Corp fd76c101-a287-f92c-e053-6294a90a4468 2024-12-17 Warnings Exact identifier application number: M016 Foster and Thrive Phenolated Calamine CALAMINE AND ZINC OXIDE AND PHENOL Strategic Sourcing Services LLC 298171e1-2826-d33b-e063-6394a90a875a 2024-12-17 Warnings Exact identifier application number: M016 Secura Dimethicone Protectant DIMETHICONE Smith & Nephew Medical Ltd 83f92ac9-4114-4192-926d-be2854a84106 2024-12-16 Warnings Exact identifier application number: M016 CVS Maximum Strength Anti-Itch Cream HYDROCORTISONE 1% CVS Health c2876cba-d7e7-de5c-e053-2a95a90a6355 2024-12-16 Warnings Exact identifier application number: M016 Blistex Medicated Lip Balm Variety Pack (Blistex Medicated Berry Lip Balm, Blistex Medicated Lip Balm, Blistex Medicated Lip) DIMETHICONE, OCTINOXATE, OCTISALATE, CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND PHENOL Blistex Inc 4121d671-521c-4f36-b2db-652c13f730c6 2024-12-16 Warnings Exact identifier application number: M016 Blistex Medicated Lip Balm Variety Pack (Blistex Medicated Berry Lip Balm, Blistex Medicated Lip Balm, Blistex Medicated Mint Lip Balm) DIMETHICONE, OCTINOXATE, AND OCTISALATE Blistex Inc 24e1d2fc-3f9d-4e86-a397-61bfbfc4d58c 2024-12-16 Warnings Exact identifier application number: M016 Balmex Diaper Rash ZINC OXIDE 11.3% Randob Labs, LTD f7f7a89d-d4e0-9faa-e053-6294a90aaf7b 2024-12-15 Warnings Exact identifier application number: M016 QC Scar ALLANTOIN 0.5% CDMA f7e3d751-a47a-2bca-e053-6394a90a6541 2024-12-15 Warnings Exact identifier application number: M016 Dr. Butler Soothing Incontinence PETROLATUM 36% Beyond Health P.A. d17a0c28-a5b7-4df0-e053-2995a90a8edd 2024-12-15 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