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 44 of 68 · 1,350 matching rows.
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