Home NDC 54031-581-01 Water Drench Hyaluronic Healing Balm
Product NDC 54031-581
Requested package NDC 54031-581-01
11-digit product format 540310581
Labeler code 54031
Product ID 54031-581_4848799d-7507-3391-e063-6394a90a5324
Type HUMAN OTC DRUG
Nonproprietary name Dimethicone
Dosage form CREAM
Route TOPICAL
Labeler Peter Thomas Roth Labs, LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-12-01
Substance DIMETHICONE
Active strength 2.41 g/48.19g
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 Water Drench Hyaluronic Healing Balm
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 2.41 g/48.19g
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 54031-581-01 Water Drench Hyaluronic Healing Balm 48.19 g in 1 TUBE CREAM 48.19 2 54031-581-02 Water Drench Hyaluronic Healing Balm 48.19 g in 1 CARTON CREAM 48.19 2 54031-581-24 Water Drench Hyaluronic Healing Balm 7 g in 1 TUBE CREAM 7 2
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 37 of 68 · 1,350 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join The Zoeun Skin Nourishing Cream COLLOIDAL OATMEAL Sturgeonbio Co.,Ltd. 42849f5c-a983-c3ce-e063-6394a90a2fb5 2025-10-01 Warnings Exact identifier application number: M016 The Zoeun Skin Sturgeon Body Wash COLLOIDAL OATMEAL Sturgeonbio Co.,Ltd. 4285320a-bf0b-915d-e063-6394a90a9cfd 2025-10-01 Warnings Exact identifier application number: M016 The Zoeun Skin Sturgeon Gel COLLOIDAL OATMEAL Sturgeonbio Co.,Ltd. 42859de3-15dd-c7b9-e063-6394a90af501 2025-10-01 Warnings Exact identifier application number: M016 The Zoeun Skin Sturgeon Hair Essence COLLOIDAL OATMAEL Sturgeonbio Co.,Ltd. 4285eb13-d1a2-0663-e063-6294a90ac40f 2025-10-01 Warnings Exact identifier application number: M016 The Zoeun Skin Total Care Cream COLLOIDAL OATMEAL Sturgeonbio Co.,Ltd. 428643c3-e932-4db5-e063-6294a90ac36c 2025-10-01 Warnings Exact identifier application number: M016 Zinc Oxide ZINC OXIDE Geri-Gentle Corporation f5cfab62-8aab-4109-b15b-4fe380f7cb9e 2025-09-29 Warnings Exact identifier application number: M016 GoodSense Petroleum Jelly WHITE PETROLATUM GOOD SENSE 3492f044-250e-45f7-8638-e3c55713e0f5 2025-09-29 Warnings Exact identifier application number: M016 Aveeno Baby Eczema Therapy Moisturizing OATMEAL Kenvue Brands LLC 2a028465-1dff-4ae7-abf6-7521c2784dd1 2025-09-26 Warnings Exact identifier application number: M016 Johnsons Baby First Touch Gift Set ZINC OXIDE Kenvue Brands LLC 3f838eb7-42a3-c96b-e063-6294a90a7491 2025-09-26 Warnings Exact identifier application number: M016 HealthWise Petroleum Jelly Original WHITE PETROLATUM Veridian Healthcare 1fb96a6c-7d13-4ccf-8fa6-55ec79e6877c 2025-09-25 Warnings Exact identifier application number: M016 HealthWise Petroleum Jelly Baby Fresh WHITE PETROLATUM Veridian Healthcare 0d3e6c1a-3ba9-4442-bae0-27312d658d07 2025-09-25 Warnings Exact identifier application number: M016 HealthWise Petroleum Jelly Cocoa Butter WHITE PETROLATUM Veridian Healthcare 5c7d9eb6-c129-4fd9-9671-2e0f0453fd28 2025-09-25 Warnings Exact identifier application number: M016 SKIN TAG REMOVER SALICYLIC ACID Shengnan (Guangzhou) Cosmetics Co., LTD 3ee79d66-e728-48dd-e063-6394a90a6463 2025-09-16 Warnings Exact identifier application number: M016 ProCure LanaCare LANOLIN 50% Twin Med LLC 3aabd4ea-107c-a02c-e063-6294a90aee07 2025-09-15 Warnings Exact identifier application number: M016 ProCure LanaCare LANOLIN 30% Twin Med LLC 3aad8395-6dc2-f600-e063-6294a90a6e9a 2025-09-15 Warnings Exact identifier application number: M016 ProCure DryDrox ALUMINUM HYDROXIDE GEL 2% Twin Med LLC 3ab4efb6-bd31-2583-e063-6294a90a415b 2025-09-15 Warnings Exact identifier application number: M016 ProCure Petroleum 100% WHITE PETROLATUM Twin Med LLC 3eddf0e7-8e9d-a311-e063-6394a90ad156 2025-09-15 Warnings Exact identifier application number: M016 NOURISHING HAND SANITIZER SPRAYS CHLORHEXIDINE DIGLUCONATE GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD 3e95a30c-8ed3-30ed-e063-6294a90a2417 2025-09-12 Warnings Exact identifier application number: M016 I.C. Ivy Block ZINC ACETATE R & R Lotion, Inc db263f4a-56a1-432c-b2e8-2a9bdd3ff129 2025-09-10 Warnings Exact identifier application number: M016 RoyceDerm Eczema Relief Cream COLLOIDAL OATMEAL 1% RoyceDerm LLC 3e09f000-01d2-0d21-e063-6294a90ac548 2025-09-05 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 54031-581-01 54031058101 48.19 g in 1 TUBE (54031-581-01) 48.19 g 2025-12-01 No No Current