water drench hyaluronic healing balm

Generic: dimethicone

Labeler: peter thomas roth labs, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name water drench hyaluronic healing balm
Generic Name dimethicone
Labeler peter thomas roth labs, llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

dimethicone 2.41 g/48.19g

Manufacturer
Peter Thomas Roth Labs, LLC

Identifiers & Regulatory

Product NDC 54031-581
Product ID 54031-581_4848799d-7507-3391-e063-6394a90a5324
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2027-12-31
Marketing Start 2025-12-01

Pharmacologic Class

Physiologic Effect
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54031581
Hyphenated Format 54031-581

Supplemental Identifiers

UNII
92RU3N3Y1O
NUI
N0000010282

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name water drench hyaluronic healing balm (source: ndc)
Generic Name dimethicone (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 2.41 g/48.19g
source: ndc
Packaging
  • 48.19 g in 1 TUBE (54031-581-01)
  • 48.19 g in 1 CARTON (54031-581-02)
  • 7 g in 1 TUBE (54031-581-24)
source: ndc

Packages (3)

54031-581-01 48.19 g in 1 TUBE (54031-581-01) 54031-581-02 48.19 g in 1 CARTON (54031-581-02) 54031-581-24 7 g in 1 TUBE (54031-581-24)

Ingredients (1)

dimethicone (2.41 g/48.19g)

Linked Drug Pages (1)

Water Drench Hyaluronic Healing Balm ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "4848799d-7507-3391-e063-6394a90a5324", "openfda": {"nui": ["N0000010282"], "unii": ["92RU3N3Y1O"], "spl_set_id": ["3f789176-1d80-d146-e063-6294a90a948a"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["Peter Thomas Roth Labs, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "48.19 g in 1 TUBE (54031-581-01)", "package_ndc": "54031-581-01", "marketing_start_date": "20251201"}, {"sample": false, "description": "48.19 g in 1 CARTON (54031-581-02)", "package_ndc": "54031-581-02", "marketing_start_date": "20251201"}, {"sample": false, "description": "7 g in 1 TUBE (54031-581-24)", "package_ndc": "54031-581-24", "marketing_start_date": "20251201"}], "brand_name": "Water Drench Hyaluronic Healing Balm", "product_id": "54031-581_4848799d-7507-3391-e063-6394a90a5324", "dosage_form": "CREAM", "pharm_class": ["Skin Barrier Activity [PE]"], "product_ndc": "54031-581", "generic_name": "Dimethicone", "labeler_name": "Peter Thomas Roth Labs, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Water Drench Hyaluronic Healing Balm", "active_ingredients": [{"name": "DIMETHICONE", "strength": "2.41 g/48.19g"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20251201", "listing_expiration_date": "20271231"}