Home NDC 84126-045 First Aid Beauty FAB Ultra Repair Rescue Barrier Balm Skin Protectant
Product NDC 84126-045
11-digit product format 841260045
Labeler code 84126
Product ID 84126-045_4c37b1d2-abaf-4a15-e063-6394a90a7970
Type HUMAN OTC DRUG
Nonproprietary name Dimethicone
Dosage form CREAM
Route TOPICAL
Labeler The Procter & Gamble Manufacturing Company
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-12-01
Substance DIMETHICONE
Active strength 1 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 First Aid Beauty FAB Ultra Repair Rescue Barrier Balm Skin Protectant
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 1 g/100g
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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84126-045-01 First Aid Beauty FAB Ultra Repair Rescue Barrier Balm Skin Protectant 1 in 1 CARTON CREAM 1 5 84126-045-01 First Aid Beauty FAB Ultra Repair Rescue Barrier Balm Skin Protectant 63.7 g in 1 TUBE CREAM 63.7 5 84126-045-02 First Aid Beauty FAB Ultra Repair Rescue Barrier Balm Skin Protectant 2 g in 1 POUCH CREAM 2 5 84126-045-10 First Aid Beauty FAB Ultra Repair Rescue Barrier Balm Skin Protectant 10 g in 1 TUBE CREAM 10 5 84126-045-30 First Aid Beauty FAB Ultra Repair Rescue Barrier Balm Skin Protectant 30 g in 1 TUBE CREAM 30 5 84126-045-63 First Aid Beauty FAB Ultra Repair Rescue Barrier Balm Skin Protectant 63.7 g in 1 TUBE CREAM 63.7 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84126-045 FIRST AID BEAUTY FAB ULTRA REPAIR RESCUE BARRIER BALM SKIN PROTECTANT (DIMETHICONE) CREAM [THE PROCTER & GAMBLE MANUFACTURING COMPANY] 3 Current NDC, 6 package rows 20250305_276c68d4-e273-4e48-e063-6294a90ab16f.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 25 of 68 · 1,357 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Kenkoderm Eczema Honey Soothing Body KENKODERM ECZEMA HONEY SOOTHING BODY LOTION Guangzhou Ariel Biotech Co., Ltd. 4865c697-05fc-eac8-e063-6294a90ae541 2026-01-14 Warnings Exact identifier application number: M016 Gold Bond Medicated eczema relief COLLOIDAL OATMEAL Chattem, Inc. 52744c77-278f-40b1-a356-14ae4366389b 2026-01-14 Warnings Exact identifier application number: M016 Water Drench Hyaluronic Healing Balm DIMETHICONE Peter Thomas Roth Labs, LLC 3f789176-1d80-d146-e063-6294a90a948a 2026-01-13 Warnings Exact identifier application number: M016 DERMEDIAL Anti-Itch OATMEAL, ZINC OXIDE Saje Natural Business Inc 385dd757-740b-8324-e063-6294a90afeee 2026-01-13 Warnings Exact identifier application number: M016 Sweet cheeks ZINC OXIDE Saje Natural Business Inc. 5fc6486e-8604-5c7b-e053-2991aa0a8d14 2026-01-13 Warnings Exact identifier application number: M016 Teevodar ALLANTOIN PEER PHARM LTD. 57a1b6d1-9439-462b-aeb9-ef806e572eaf 2026-01-12 Warnings Exact identifier application number: M016 Botao Baby Diaper Rash Cream ZINC OXIDE Peer Pharm Ltd. df60a70e-e6c0-41b3-e053-2995a90af176 2026-01-12 Warnings Exact identifier application number: M016 ECZEMA HAND RELIEF COLLOIDAL OATMEAL Skinfix, Inc. 0389bab7-04fb-7cfc-e063-6394a90a22d8 2026-01-12 Warnings Exact identifier application number: M016 SKINFIX HAND REPAIR OATMEAL Skinfix, Inc. 1b65fc81-1b9e-4260-829a-332cf6891d02 2026-01-12 Warnings Exact identifier application number: M016 ECZEMA INTENSIVE DAILY RELIEF BODY COLLOIDAL OATMEAL CREAM Skinfix, Inc. 0be3c631-bc9b-00a9-e063-6394a90abcbb 2026-01-12 Warnings Exact identifier application number: M016 Sarna COLLOIDAL OATMEAL Crown Laboratories, Inc. 2d6b1872-9f4d-9eb3-e063-6394a90ab675 2026-01-12 Warnings Exact identifier application number: M016 XIMONTH Nail Repairs Patches GLYCERIN Shantou Ximonth Biotechnology Co., Ltd. 47f1a711-5d6f-c023-e063-6294a90aa801 2026-01-09 Warnings Exact identifier application number: M016 Endit zinc oxide skin protection ZINC OXIDE EndIt Laboratories, Inc. e60bb0da-3349-f8f9-e053-2a95a90a9051 2026-01-09 Warnings Exact identifier application number: M016 Endit Zinc Oxide Skin Protectant ZINC OXIDE Endit Laboratories, Inc. 55b3aa07-871d-421b-b76a-c2d359d6003f 2026-01-09 Warnings Exact identifier application number: M016 Flanders Buttocks WHITE PETROLATUM, ZINC OXIDE Flanders Inc 32371159-c76d-41b0-e054-00144ff88e88 2026-01-09 Warnings Exact identifier application number: M016 Pure Petrolatum Jelly PETROLATUM MY IMPORTS USA LLC 47da77ea-ab4e-fc3c-e063-6394a90a27b7 2026-01-08 Warnings Exact identifier application number: M016 Z-Bum DIAPER RASH CREAM GM Pharmaceuticals, Inc 2a36f396-3a30-3f3f-e054-00144ff8d46c 2026-01-08 Warnings Exact identifier application number: M016 Daily VLotion DIMETHICONE Kindra 1cc4b804-6483-68fd-e063-6294a90a38e4 2026-01-08 Warnings Exact identifier application number: M016 V Relief Serum DIMETHICONE Kindra 1cd8a9e9-ac88-1799-e063-6294a90a3278 2026-01-08 Warnings Exact identifier application number: M016 DR SMITHS DIAPER ZINC OXIDE Mission Pharmacal 7705b182-acf7-4195-9996-7d9fcdfbf055 2026-01-08 Warnings Exact identifier application number: M016
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 84126-045-01 84126004501 1 TUBE in 1 CARTON (84126-045-01) / 63.7 g in 1 TUBE 1 tube 2026-02-01 No No Current 84126-045-02 84126004502 2 g in 1 POUCH (84126-045-02) 2 g 2024-12-01 2026-12-01 Yes No Historical 84126-045-10 84126004510 10 g in 1 TUBE (84126-045-10) 10 g 2024-12-01 No No Current 84126-045-30 84126004530 30 g in 1 TUBE (84126-045-30) 30 g 2024-12-01 No No Current 84126-045-63 84126004563 63.7 g in 1 TUBE (84126-045-63) 63.7 g 2024-12-01 2026-12-01 No No Historical