Over-the-counter drug · OTC MONOGRAPH DRUG
Water Drench Hyaluronic Healing Balm (Dimethicone) NDC 54031-581
Dimethicone 2.41 g/48.19g · Cream · Topical · Peter Thomas Roth Labs, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54031-581-01 | 54031058101 | 48.19 g in 1 TUBE (54031-581-01)Marketed from Dec 1, 2025 | |
| 54031-581-02 | 54031058102 | 48.19 g in 1 CARTON (54031-581-02)Marketed from Dec 1, 2025 | |
| 54031-581-24 | 54031058124 | 7 g in 1 TUBE (54031-581-24)Marketed from Dec 1, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Water Drench Hyaluronic Healing Balm
- Generic name (nonproprietary)
- dimethicone
- Active ingredients
- Dimethicone — 2.41 g/48.19g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Peter Thomas Roth Labs, LLCNDC labeler code 54031
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 016
- Marketing start
- Listing expires
- Other FDA classes
- Skin Barrier Activity (Physiologic effect)
- Identifiers
- Product ID 54031-581_4848799d-7507-3391-e063-6394a90a5324SPL ID 4848799d-7507-3391-e063-6394a90a5324SPL set ID 3f789176-1d80-d146-e063-6294a90a948aUNII 92RU3N3Y1O
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N454031058101followed by a unit qualifier and the quantityPackage 54031-0581-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses Helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin. Helps protect from the drying effects of wind and cold weather.
Excerpt only. Read the full label for complete information.
About NDC 54031-581
- What is NDC 54031-581?
- 54031-581 is the product NDC for Water Drench Hyaluronic Healing Balm, Dimethicone 2.41 g/48.19g cream, listed with the FDA by Peter Thomas Roth Labs, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Water Drench Hyaluronic Healing Balm (Dimethicone).
- What is the active ingredient?
- Dimethicone.
- Who is the labeler?
- Peter Thomas Roth Labs, LLC, NDC labeler code 54031. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Water Drench Hyaluronic Healing Balm?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under M 016
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Colloidal oatmeal | Oatmeal 10 mg/g | CreamTopical | Meijer, Inc. | 79481-6601 |
| Gold Bond Eczema Relief Medicated Hand Creamcolloidal oatmeal | Oatmeal 2 g/100g | CreamTopical | Chattem, Inc. | 41167-0668 |
| Venrockrosemary oil | Rosmarinus officinalis (Rosemary) leaf oil 55 g/100g; Biotin .001 g/100g | OilTopical | Guangzhou Oupeng Cosmetics Co., Ltd | 85772-0007 |
| First Aid Beauty FAB Ultra Repair Body Skin Protectantcolloidal oatmeal | Oatmeal .5 g/100g | LotionTopical | The Procter & Gamble Manufacturing Company | 69423-726 |
| AHHH Bite Reliefsodium bicarbonate | Sodium bicarbonate 5 g/25g | GelTopical | 78271 | 78271-041 |
| Vitacilina Bebe Diaper Rashzinc oxide | Zinc oxide 400 mg/g | OintmentTopical | Taisho Pharmaceutical California Inc. | 81929-002 |
| Witch Hazel | Witch hazel 842 mg/mL | LiquidTopical | TOP CARE (Topco Associates LLC) | 36800-039 |
| First Aid Beauty Face and Body Bestsellers Kitcolloidal oatmeal | — | KitTopical | The Procter & Gamble Manufacturing Company | 84126-911 |
| Skin Protectant with 33% Petrolatum Advance Moisturizing Creampetrolatum | Petrolatum 33 g/100g | CreamTopical | Aldermed Inc. | 87236-011 |
| Theriac Advanced Healinglanolin | Lanolin 350.8 mg/g | OintmentTopical | Sheffield Pharmaceuticals LLC | 11527-325 |
| XtraCare Creamy Petroleum Jellypetrolatum | Petrolatum 38 g/127g | JellyTopical | Rejoice International | 57337-060 |
| Sarnacolloidal oatmeal | Oatmeal 20 mg/mL | LotionTopical | Crown Laboratories, Inc. | 0316-0256 |
| Zinc Oxide 20%zinc oxide | Zinc oxide .2 g/g | OintmentTopical | Trifecta Pharmaceuticals USA | 69396-021 |
| FIRST AID BEAUTY FAB ULTRA REPAIR SKIN PROTECTANT Kitcolloidal oatmeal | — | KitTopical | The Procter & Gamble Manufacturing Company | 84126-912 |
| ProCure Zinc Oxidezinc oxide | Zinc oxide 20 g/100g | OintmentTopical | Twin Med LLC | 55681-017 |
| XtraCare Creamy Petroleum Jellypetrolatum | Petrolatum 38 g/127g | JellyTopical | Rejoice International | 57337-061 |
| Zinc Oxide 20%zinc oxide | Zinc oxide .2 g/g | OintmentTopical | Trifecta Pharmaceuticals USA | 69396-021 |
| Desitin Maximum Strength Zinc Oxide Diaper Rashzinc oxide | Zinc oxide 400 mg/g | PasteTopical | Kenvue Brands LLC | 69968-0396 |
| Hydrophor | Petrolatum 42 g/100g | OintmentTopical | Akron Pharma Inc. | 71399-5101 |
| Attitude Diaper Cream Zinc Unscentedzinc oxide | Zinc oxide 15 g/100g | StickTopical | 9055-7588 Quebec Inc. (Attitude) | 61649-260 |
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