Water Drench Hyaluronic Healing Balm

Product NDC
54031-581
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

Additional Listing Data#

Finished product
Yes
Brand name base
Water Drench Hyaluronic Healing Balm
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE2.41 g/48.19g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54031-581-01Water Drench Hyaluronic Healing Balm48.19 g in 1 TUBECREAM48.192
54031-581-02Water Drench Hyaluronic Healing Balm48.19 g in 1 CARTONCREAM48.192
54031-581-24Water Drench Hyaluronic Healing Balm7 g in 1 TUBECREAM72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
54031-581-015403105810148.19 g in 1 TUBE (54031-581-01) 48.19 g2025-12-01NoNoHistorical
54031-581-025403105810248.19 g in 1 CARTON (54031-581-02) 48.19 g2025-12-01NoNoHistorical
54031-581-24540310581247 g in 1 TUBE (54031-581-24) 7 g2025-12-01NoNoHistorical