Over-the-counter drug · OTC MONOGRAPH DRUG
Pediadermics eczema 3 (Colloidal oatmeal, dimethicone) NDC 76348-580
Dimethicone 3.36 g/168g; Oatmeal .168 g/168g · Cream · Topical · Renu Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76348-580-06 | 7634805800676348058006 | 168 g in 1 TUBE (76348-580-06)Marketed from Oct 1, 2020 |
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)
- Pediadermics eczema 3
- Generic name (nonproprietary)
- colloidal oatmeal, dimethicone
- Active ingredients
- Dimethicone — 3.36 g/168gOatmeal — .168 g/168g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Renu Laboratories, LLCNDC labeler code 76348
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 016
- Marketing start
- Listing expires
- Other FDA classes
- Allergens (Chemical structure)Cell-mediated Immunity (Physiologic effect)Dietary Proteins (Chemical structure)Grain Proteins (EXT)Increased Histamine Release (Physiologic effect)Plant Proteins (Chemical structure)Skin Barrier Activity (Physiologic effect)
- Identifiers
- Product ID 76348-580_44fe1bad-8844-9960-e063-6394a90a8a7aSPL ID 44fe1bad-8844-9960-e063-6394a90a8a7aSPL set ID af861f0b-4387-6861-e053-2995a90a8bfaUNII 92RU3N3Y1O, 8PI54V663Y
- Pharmacologic class
- Non-Standardized Food Allergenic Extract; Non-Standardized Plant Allergenic Extract
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
N476348058006followed by a unit qualifier and the quantityPackage 76348-0580-06. 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 Temporarily protects sensitive skin and helps relieve minor skin irritation due to eczema. Temporarily helps prevent and relieve chapped or cracked skin.
Excerpt only. Read the full label for complete information.
About NDC 76348-580
- What is NDC 76348-580?
- 76348-580 is the product NDC for Pediadermics eczema 3, Dimethicone 3.36 g/168g; Oatmeal .168 g/168g cream, listed with the FDA by Renu Laboratories, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pediadermics eczema 3 (Colloidal Oatmeal, Dimethicone).
- What is the active ingredient?
- Dimethicone, Oatmeal.
- Who is the labeler?
- Renu Laboratories, LLC, NDC labeler code 76348. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pediadermics eczema 3?
- 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 |
|---|---|---|---|---|
| Barrier Balmcolloidal oatmeal balm | Oatmeal 1 g/100g | SalveTopical | Tubby Todd | 73088-305 |
| Earthmed Lip Balm Pineappleallantoin | Allantoin .045 g/4.455g | SalveTopical | Earthmed LLC | 82876-988 |
| Welmedix HomeCare PRO Fragile Skin Protectantpetrolatum | Petrolatum 42 g/100g | OintmentTopical | Welmedix LLC | 24330-413 |
| Petroleumwhite petrolatum | Petrolatum 1 g/g | JellyTopical | H E B | 37808-015 |
| Pure Petrolatum Jellypetrolatum | Petrolatum 100 g/100g | JellyTopical | MY IMPORTS USA LLC | 51628-4600 |
| A and Dpetrolatum | Petrolatum 76 g/100g | OintmentTopical | Safetec of America, Inc. | 61010-4405 |
| Dermatitis Face Balmcolloidal oatmeal | Oatmeal 5 g/100g | OintmentTopical | Skinfix, Inc. | 61328-121 |
| McKesson Skin Protectantzinc oxide | Zinc oxide 50 mg/mL | CreamTopical | McKesson Medical-Surgical Inc. | 68599-5312 |
| All Over Lavender Rosemarycolloidal oat ointment | Oatmeal 1 g/100g | OintmentTopical | Tubby Todd | 73088-303 |
| XIMONTH GLP-1 Patchesglycerin | Acetyl hexapeptide-8 amide .006 mg/30mg; Rose oil .006 mg/30mg | PatchTopical | Shantou Ximonth Biotechnology Co., Ltd. | 84989-009 |
| Deep Renewal Broad Spectrumdimethicone, avobenzone, homosalate, and octisalate | Dimethicone 2 g/100g + 3 more ingredients | StickTopical | Blistex Inc | 10157-1170 |
| Skin Soothing Cream - Nut Freecolloidal oatmeal | Oatmeal 1 mg/g | CreamTopical | Allure Labs | 62742-4194 |
| Lavender Scent Petroleumwhite petroleum | Petrolatum 99.9 g/100g | JellyTopical | Jell Pharmaceuticals Pvt Ltd | 30400-514 |
| Witch Hazel | Witch hazel 842 mg/mL | LiquidTopical | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 49035-039 |
| Eczema Dermatitis Relief Balmcolloidal oatmeal | Oatmeal 5 g/100g | CreamTopical | Skinfix, Inc. | 61328-112 |
| Dovenourishing hand sanitizer sensitive skin 8hr moisturization | Alcohol 610 mg/mL | GelTopical | Conopco Inc. d/b/a/ Unilever | 64942-1996 |
| Petroleum Skin Protectantwhite petrolatum | Petrolatum 1 g/g | JellyTopical | Pharmacy Value Alliance, LLC | 68016-069 |
| Sweet Cheeks Diaper Sprayerzinc oxide diaper paste spray | Zinc oxide 14.9 g/100g | SprayTopical | Tubby Todd | 73088-304 |
| Estrogen Estriol Cream5% estriol | Estriol 5 g/100g | CreamTopical | YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD | 83364-026 |
| Earthmed FS massage oilallantoin | Allantoin 1 g/108.48g | OilTopical | Earthmed LLC | 82876-986 |
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