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
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 |
|---|---|
| DIMETHICONE | 2.41 g/48.19g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 92RU3N3Y1O | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3f789176-1d80-d146-e063-6294a90a948a | Available on FDA.report |
DailyMed Package Descriptions#
| 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Skin Mercy Recovery Cream | COLLOIDAL OATMEAL | Cultskin Apothecary, Inc. | 4bac19f3-13bb-8d18-e063-6394a90aa393 | 2026-02-25 | Warnings | M016 |
| Skin Mercy Intense Recovery Cream | COLLOIDAL OATMEAL | Cultskin Apothecary, Inc. | 468f21c6-2d6f-1654-e063-6394a90ab2f5 | 2026-02-25 | Warnings | M016 |
| Magnet Eye Sheet Mask | EYE MASK | Guangdong Bisutang Biotechnology Co., LTD | 4a0a84d4-4024-5ea7-e063-6394a90a2b6c | 2026-02-24 | Warnings | M016 |
| Petroleum Skin Protectant | WHITE PETROLATUM | Family Dollar Stores, Inc | ac7da793-8a39-4b47-b075-a4c4820cadad | 2026-02-24 | Warnings, Adverse reactions | M016 |
| Calamine | FERRIC OXIDE RED | Family Dollar Stores, Inc | 1a03331e-3676-451c-be22-9a547e8ae6e2 | 2026-02-24 | Warnings, Adverse reactions | M016 |
| Advanced Healing | PETROLATUM | Family Dollar Stores, Inc | 7e64a424-afdb-4eb9-b6af-7b8123f1e207 | 2026-02-24 | Warnings, Adverse reactions | M016 |
| Petroleum Skin Protectant | WHITE PETROLATUM | H E B | e6154e44-d7b2-429c-9bc7-5c064220d3fb | 2026-02-24 | Warnings, Adverse reactions | M016 |
| Diaper Rash | ZINC OXIDE | H E B | f0b31d52-2903-487a-aa70-0dbdf4c4d7e7 | 2026-02-24 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | H E B | ff79e42c-da3f-4aec-acf4-cc26e10a1d08 | 2026-02-24 | Warnings, Adverse reactions | M016 |
| Dimethicone | DIMETHICONE | H E B | a8ad595a-c811-4534-82e0-9a01085b4b1e | 2026-02-24 | Warnings, Adverse reactions | M016 |
| Colloidal oatmeal | COLLOIDAL OATMEAL | H E B | ce9ffcc1-a4c3-4771-ae27-ba99c74bb1ba | 2026-02-24 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | H E B | 460802cc-c1b9-41cb-afe3-ca4078175efb | 2026-02-24 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | H E B | 2dd85211-0840-4d0d-8ba7-ea6184a50942 | 2026-02-24 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | Meijer, Inc. | 12867b23-b203-4bd7-af6d-efddeead26be | 2026-02-24 | Warnings, Adverse reactions | M016 |
| Colloidal oatmeal | COLLOIDAL OATMEAL | Meijer, Inc. | c7a4b7f2-4de9-470c-9f5b-0142bd935137 | 2026-02-24 | Warnings, Adverse reactions | M016 |
| Pure petroleum | WHITE PETROLATUM | Better Living Brands, LLC | 75cb8f17-6ef2-403e-ab6e-d8e1e8168ec8 | 2026-02-23 | Warnings, Adverse reactions | M016 |
| WHITE PETROLATUM | PETROLATUM | Sion Biotext Medical Ltd | 53ca3aeb-1d5d-4964-adb5-1cfa901642da | 2026-02-23 | Warnings | M016 |
| Clear Anti Itch | PRAMOXINE HCL, ZINC ACETATE | Better Living Brands, LLC | 1d491635-9605-44fa-9860-ea23e4e8b21c | 2026-02-23 | Warnings, Adverse reactions | M016 |
| Advanced Healing | PETROLATUM | Better Living Brands, LLC | ba50f2b2-aff8-42cd-8af0-369060a901fb | 2026-02-23 | Warnings, Adverse reactions | M016 |
| Oatmeal | DIMETHICONE | Better Living Brands, LLC | d28c5a60-0597-424f-bf7f-08dca39b22f5 | 2026-02-23 | Warnings, Adverse reactions | M016 |
Packages#
| 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 |
| 54031-581-02 | 54031058102 | 48.19 g in 1 CARTON (54031-581-02) | 48.19 g | 2025-12-01 | No | No | Current |
| 54031-581-24 | 54031058124 | 7 g in 1 TUBE (54031-581-24) | 7 g | 2025-12-01 | No | No | Current |