AD Medicated Rash
- Product NDC
- 65197-406
- 11-digit product format
- 651970406
- Labeler code
- 65197
- Product ID
- 65197-406_8fd6a4a0-06b0-4006-b00c-b910dfeb6d7b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- AD Medicated Rash
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- WellSpring Pharmaceutical Corporation
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-01-15
- Substance
- MINERAL OIL; OATMEAL
- Active strength
- 30; 2 g/100g; 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
- AD Medicated Rash
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MINERAL OIL | 30 g/100g |
| OATMEAL | 2 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| T5L8T28FGP | Internal UNII lookup |
| 8PI54V663Y | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2710836 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| aac345bf-ea66-4f5b-a497-c24ea72f93ea | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65197-406-15 | AD Medicated Rash | 42.5 g in 1 TUBE | OINTMENT | 42.5 | 5 | |
| 65197-406-15 | AD Medicated Rash | 1 in 1 BOX | OINTMENT | 1 | 5 | |
| 65197-406-52 | AD Medicated Rash | 431 g in 1 JAR | OINTMENT | 431 | 5 |
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 |
|---|---|---|---|---|
| 2710836 | colloidal oatmeal 2 % / mineral oil 30 % Topical Ointment | PSN | aac345bf-ea66-4f5b-a497-c24ea72f93ea | 5 |
| 2710836 | colloidal oatmeal 0.02 MG/MG / mineral oil 0.3 MG/MG Topical Ointment | SCD | aac345bf-ea66-4f5b-a497-c24ea72f93ea | 5 |
| 2710836 | colloidal oatmeal 2 % / mineral oil 30 % Topical Ointment | SY | aac345bf-ea66-4f5b-a497-c24ea72f93ea | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 65197-406-15 | 65197040615 | 1 TUBE in 1 BOX (65197-406-15) / 42.5 g in 1 TUBE | 1 tube | 2025-01-15 | No | No | Current |
| 65197-406-52 | 65197040652 | 431 g in 1 JAR (65197-406-52) | 431 g | 2025-04-30 | No | No | Current |