ECZEMA DERMATITIS RELIEF BALM
- Product NDC
- 61328-112
- 11-digit product format
- 613280112
- Labeler code
- 61328
- Product ID
- 61328-112_5b4ad054-9ed9-c5f3-e063-6294a90a0d33
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- COLLOIDAL OATMEAL
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Skinfix, Inc.
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-10-01
- 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
- ECZEMA DERMATITIS RELIEF BALM
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OATMEAL | 5 g/100g |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 124351b2-6dbf-42d0-9ea7-f0e299215f9a | Product name | 1 | 20210115 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 91c62db0-0295-c81c-d10a-0856c259edd6 | Product name | 2 | 20200428 |
| d32bc2b8-0bb7-2216-87aa-24639646e202 | Product name | 3 | 20190619 |
| 444b3e50-f226-46ef-bfca-2e7035d140cd | Product name | 1 | 20190611 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 597b1cfd-7b31-5048-62be-ca5cd740da2f | Product name | 1 | 20140508 |
| ec2149b3-5c6d-5344-f757-c86411073075 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61328-112-20 | ECZEMA DERMATITIS RELIEF BALM | 50 g in 1 BOTTLE, PUMP | CREAM | 50 | 4 |
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 |
|---|---|---|---|---|---|---|
| insect bite relief 01 | MENTHOL | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 006e457d-bfcd-791a-e063-6294a90a8d66 | 2024-09-23 | Warnings | M016 |
| dabur | ZINC OXIDE | Dabur India Limited | 22cd1e7a-5448-b3f6-e063-6394a90a880d | 2024-09-23 | Warnings | M016 |
| DABUR Vitamin A and D | WHITE PETROLATUM | Dabur India Limited | 22cd44ef-4b02-604d-e063-6394a90a7a0a | 2024-09-23 | Warnings | M016 |
| DABUR ZINC OXIDE 3.8% | ZINC OXIDE | Dabur India Limited | 2290bbe2-8a88-b94e-e063-6294a90a7e38 | 2024-09-20 | Warnings | M016 |
| Aveeno Baby Daily Moisture | DIMETHICONE | Kenvue Brands LLC | b34c8e71-7fad-484c-b387-3c424f50b743 | 2024-09-19 | Warnings | M016 |
| Evereden Intensive Eczema Balm | COLLOIDAL OATMEAL | Eden Brands Inc. | 2243d4ca-5ca4-54d0-e063-6394a90a3940 | 2024-09-16 | Warnings | M016 |
| Whipped Gel | COLLOIDAL OATMEAL | OCEAN OLIVE LLC | 222b381c-665e-177d-e063-6394a90a3306 | 2024-09-15 | Warnings | M016 |
| BioBarrier Renewal Cream | ALLANTOIN | bluemercury | 1ee15f84-0561-3cd2-e063-6394a90ab68e | 2024-09-15 | Warnings | M016 |
| Calamine | CALAMINE AND ZINC OXIDE | Strategic Sourcing Services, LLC | 22173332-9d09-768c-e063-6394a90a94e1 | 2024-09-14 | Warnings | M016 |
| Diaper Rash Cream 5.6oz | ZINC OXIDE | China Ningbo Shangge Cosmetics Technology Corp. | 21a7c4ce-1360-931c-e063-6294a90aa66d | 2024-09-11 | Warnings | M016 |
| Healing Cream 3oz | PETROLATUM | China Ningbo Shangge Cosmetics Technology Corp. | 21bdbb13-cc64-b5d7-e063-6294a90ae3fd | 2024-09-11 | Warnings | M016 |
| Healing Cream15oz | PETROLATUM | Rejoice International Corp. | 21e4026c-d3da-e4f7-e063-6394a90aabed | 2024-09-11 | Warnings | M016 |
| Baby Balm Stick 0.65oz | PETROLATUM OINTMENT | China Ningbo Shangge Cosmetics Technology Corp. | 21c0b614-ea19-e98d-e063-6294a90ac44e | 2024-09-10 | Warnings | M016 |
| Aveeno Skin Relief Moisturizing Fragrance Free | DIMETHICONE | Kenvue Brands LLC | 65476a2a-8cd4-4477-ac27-9a06f41e4711 | 2024-09-09 | Warnings | M016 |
| Diaper Rash Cream 15oz | ZINC OXIDE | Rejoice International Corp. | 213213ab-f935-a62e-e063-6394a90af96b | 2024-09-03 | Warnings | M016 |
| Diaper Rash Cream 5.6oz | ZINC OXIDE | Rejoice International Corp. | 2133876b-eaf0-f988-e063-6394a90aae4d | 2024-09-03 | Warnings | M016 |
| Baby Balm Stick 0.65oz | PETROLATUM | Rejoice International Corp. | 20cf3bb8-4ab8-2980-e063-6294a90ad631 | 2024-08-29 | Warnings | M016 |
| SUDOCREM SKIN PROTECTANT | ZINC OXIDE | LEDA INNOVATIONS USA, INC. | 20d2cf0b-d237-fd78-e063-6394a90a8d03 | 2024-08-29 | Warnings | M016 |
| Healing Cream 3oz | PETROLATUM | Rejoice International Corp. | 20c9b964-c9af-d63a-e063-6294a90ab979 | 2024-08-28 | Warnings | M016 |
| Babyganics Soothing Itch | OATMEAL | KAS Direct, LLC | 5c2806fb-5af4-4532-b31a-be77bb23b277 | 2024-08-28 | Warnings | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1595494 | colloidal oatmeal 5 % Topical Cream | PSN | fb801d20-9bec-1c71-e053-6394a90a6e95 | 4 |
| 1595494 | colloidal oatmeal 50 MG/ML Topical Cream | SCD | fb801d20-9bec-1c71-e053-6394a90a6e95 | 4 |
| 1595494 | colloidal oatmeal 5 % Topical Cream | SY | fb801d20-9bec-1c71-e053-6394a90a6e95 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 61328-112-20 | 61328011220 | 50 g in 1 BOTTLE, PUMP (61328-112-20) | 50 g | 2023-10-01 | No | No | Current |
| 61328-112-30 | 61328011230 | 1 TUBE in 1 CARTON (61328-112-30) / 40 g in 1 TUBE | 1 tube | 2026-09-12 | No | No | Current |