DERMATITIS FACE BALM
- Product NDC
- 61328-121
- 11-digit product format
- 613280121
- Labeler code
- 61328
- Product ID
- 61328-121_47ebdead-4009-888b-e063-6394a90a1362
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Colloidal Oatmeal
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Skinfix, Inc.
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-02-03
- Substance
- OATMEAL
- Active strength
- 5 g/100g
- Pharmacologic classes
- Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
- 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
- DERMATITIS FACE BALM
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OATMEAL | 5 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8PI54V663Y | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1738987 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 86d2db7d-f1d4-4bca-aba4-d4c96b83c1a6 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| baf7f49c-75b6-496b-a00e-8e766a8e4f03 | Product name | 1 | 20210127 |
| ebc62596-fc97-4d03-9483-7ba095d25db7 | Product name | 1 | 20151210 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61328-121-12 | DERMATITIS FACE BALM | 13.5 g in 1 TUBE | OINTMENT | 13.5 | 7 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| First Aid Beauty FAB Ultra Repair Body Skin Protectant | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | 1a9d86fc-ef32-baed-e063-6394a90a7d74 | 2026-03-12 | Warnings | M016 |
| Meijer Scar Gel | ALLANTOIN 0.5% | Meijer | 4c108c34-72f3-1382-e063-6394a90a7f2c | 2026-03-11 | Warnings | M016 |
| E2 hand wash | E2 SANITIZING HAND SOAP | Horizon Tool Inc. | a40afa46-a07d-f864-e053-2a95a90aef8a | 2026-03-11 | Warnings | M016 |
| First Aid Beauty FAB Ultra Repair Skin Protectant Sugar Cookie | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | 4576cd28-9530-4db4-e063-6394a90a9fd3 | 2026-03-10 | Warnings | M016 |
| Diaper Rash | ZINC OXIDE | Lidl US, LLC | e399b33f-5f7c-47eb-8e9b-1721ae4680b5 | 2026-03-10 | Warnings, Adverse reactions | M016 |
| Vitamin A D | WHITE PETROLATUM | Sion Biotext Medical Ltd. | 503c4ab9-1f60-48e2-af47-7ef996466a5b | 2026-03-09 | Warnings | M016 |
| Trstay | RETINOL SERUM | Shenzhen yuehaotong Technology Co.,Ltd | 4c6e20dd-0a71-a96b-e063-6294a90ab833 | 2026-03-07 | Warnings | M016 |
| 2-Pack Facial Serum | 2-PACK FACIAL SERUM | Guangzhou Ariel Biotech Co., Ltd. | 27c7f645-cfb3-6db1-e063-6394a90a42ff | 2026-03-06 | Warnings | M016 |
| 2-Pack Facial Serum | 2-PACK FACIAL SERUM | Guangzhou Ariel Biotech Co., Ltd. | 27c89fc6-016b-d359-e063-6394a90a5602 | 2026-03-06 | Warnings | M016 |
| Boudreauxs | ZINC OXIDE | C.B. Fleet Company, Inc. | f8f626c8-13ae-4b3b-ae3f-e0dc800fcb4a | 2026-03-06 | Warnings | M016 |
| First Aid Beauty FAB Ultra Repair Rescue Barrier Balm Skin Protectant | DIMETHICONE | The Procter & Gamble Manufacturing Company | 276c68d4-e273-4e48-e063-6294a90ab16f | 2026-03-04 | Warnings | M016 |
| Nicotine Patches | NICOTINE PATCHES | Zhejiang FTA Shengzuozhi Biotechnology Co., LTD | 4c1d00b3-313b-933f-e063-6294a90ac46f | 2026-03-03 | Warnings | M016 |
| Zinc Oxide | ZINC OXIDE | Amazon.com Services LLC | 495fffd7-7b64-954a-e063-6394a90a81fd | 2026-03-03 | Warnings, Adverse reactions | M016 |
| Calamine | CALAMINE, PRAMOXINE HCL | Amazon.com Services LLC | aceb0b10-8c90-4a06-8c47-cd1a2b4676a3 | 2026-03-03 | Warnings, Adverse reactions | M016 |
| Witch Hazel | WITCH HAZEL | Amazon.com Services LLC | 134e07a1-5236-4088-baf9-1ff33126f793 | 2026-03-03 | Warnings, Adverse reactions | M016 |
| Diaper Rash | ZINC OXIDE | Old East Main Co. | 7f56ab98-dbd8-412a-8c31-bb6302b7f329 | 2026-03-02 | Warnings, Adverse reactions | M016 |
| Calamine | FERRIC OXIDE RED | Old East Main Co. | c38c77fd-abbf-4c87-a9c0-a0e21ed3f97d | 2026-03-02 | Warnings, Adverse reactions | M016 |
| Pure petroleum | WHITE PETROLATUM | Old East Main Co. | ae8583c0-1b52-461d-8506-ec7524f1b4c4 | 2026-03-02 | Warnings, Adverse reactions | M016 |
| Healing for Babies | PETROLATUM | Old East Main Co. | aa1acc24-56af-4708-bf76-23d4de3d089e | 2026-03-02 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | Old East Main Co. | de8d8071-ecb2-4719-8c7b-7944f27810d6 | 2026-03-02 | Warnings, Adverse reactions | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1738987 | colloidal oatmeal 5 % Topical Ointment | PSN | 86d2db7d-f1d4-4bca-aba4-d4c96b83c1a6 | 7 |
| 1738987 | colloidal oatmeal 0.05 MG/MG Topical Ointment | SCD | 86d2db7d-f1d4-4bca-aba4-d4c96b83c1a6 | 7 |
| 1738987 | colloidal oatmeal 5 % Topical Ointment | SY | 86d2db7d-f1d4-4bca-aba4-d4c96b83c1a6 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 61328-121-12 | 61328012112 | 13.5 g in 1 TUBE (61328-121-12) | 13.5 g | 2022-02-03 | 0000-00-00 | No | No | Current |