Over-the-counter drug · OTC MONOGRAPH DRUG
Comfort Shield Barrier (Dimethicone) NDC 53462-915
Dimethicone 30 mg/g · Cloth · Topical · Sage Products LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53462-915-24 | 5346209152453462091524 | 24 APPLICATOR in 1 PACKAGE (53462-915-24) / 24 g in 1 APPLICATORMarketed from Dec 11, 2023 | |
| 53462-915-50 | 5346209155053462091550 | 3 APPLICATOR in 1 PACKAGE (53462-915-50) / 26 g in 1 APPLICATORMarketed from Jan 1, 1990 | |
| 53462-915-51 | 5346209155153462091551 | 3 APPLICATOR in 1 PACKAGE (53462-915-51) / 19 g in 1 APPLICATORMarketed from Jan 1, 1990 | |
| 53462-915-80 | 5346209158053462091580 | 8 APPLICATOR in 1 PACKAGE (53462-915-80) / 27 g in 1 APPLICATORMarketed from Jan 1, 1990 |
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)
- Comfort Shield Barrier
- Generic name (nonproprietary)
- dimethicone
- Active ingredients
- Dimethicone — 30 mg/g
- Dosage form
- Cloth
- Route
- Topical
- Labeler
- Sage Products LLCNDC labeler code 53462
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 016
- Marketing start
- Listing expires
- Other FDA classes
- Skin Barrier Activity (Physiologic effect)
- Identifiers
- Product ID 53462-915_54ee06dc-1e51-3f8a-e063-6294a90a1fb0SPL ID 54ee06dc-1e51-3f8a-e063-6294a90a1fb0SPL set ID cc08f571-84ae-4c2f-b09d-a83a8efc39f5RxCUI 968663, 1088604UNII 92RU3N3Y1O
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
N453462091524followed by a unit qualifier and the quantityPackage 53462-0915-24. 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 helps seal out wetness helps treat and prevent perineal dermatitis protects from minor skin irritation associated with perineal dermatitis
Excerpt only. Read the full label for complete information.
About NDC 53462-915
- What is NDC 53462-915?
- 53462-915 is the product NDC for Comfort Shield Barrier (dimethicone), Dimethicone 30 mg/g cloth, listed with the FDA by Sage Products LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Comfort Shield Barrier (Dimethicone).
- What is the active ingredient?
- Dimethicone.
- Who is the labeler?
- Sage Products LLC, NDC labeler code 53462. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Comfort Shield Barrier?
- 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 |
|---|---|---|---|---|
| 2-Pack Facial Serum | Water 78.894 g/100mL + 4 more ingredients | LiquidCutaneous | Guangzhou Ariel Biotech Co., Ltd. | 84148-011 |
| 2-Pack Facial Serum | 3-o-ethyl ascorbic acid .5 g/100mL + 3 more ingredients | LiquidCutaneous | Guangzhou Ariel Biotech Co., Ltd. | 84148-012 |
| 3M Cavilon Durable Barrierdimethicone | Dimethicone 13000 mg/L | CreamTopical | Solventum US LLC | 17518-030 |
| 4% 10gTATTOO Numb Cream4% lidocaine | Lidocaine 100 mg/g | CreamCutaneous | Shengnan (Guangzhou) Cosmetics Co., LTD | 84019-031 |
| 4% TATTOO Numb Cream4% lidocaine | Lidocaine 100 mg/g | CreamCutaneous | Shengnan (Guangzhou) Cosmetics Co., LTD | 84019-030 |
| 456 Acne Relief Creamniacinamide,salicylic acid,centella asiatica root,coptis chinensis root | Salicylic acid 380 mg/50g + 3 more ingredients | CreamTopical | Guangzhou Senmai Biotechnology Co.,Ltd. | 84509-111 |
| 5% Dr.care Numb creamlidocaine | Lidocaine 100 mg/g | CreamCutaneous | Shengnan (Guangzhou) Cosmetics Co., LTD | 84019-028 |
| 5% Minoxidil | Minoxidil 2 g/100g + 3 more ingredients | SprayCutaneous | Guangzhou Yanxi Biotechnology Co., Ltd | 84025-328 |
| 5% Minoxidil | Minoxidil 2 g/100g + 3 more ingredients | SprayCutaneous | Guangzhou Yanxi Biotechnology Co., Ltd | 84025-329 |
| 5% Minoxidil | Biotin .05 g/100g; Niacinamide 2.5 g/100g | SprayCutaneous | Guangzhou Yanxi Biotechnology Co., Ltd | 84025-335 |
| 5% Minoxidil | Minoxidil 5 g/100g + 5 more ingredients | SprayCutaneous | Guangzhou Yanxi Biotechnology Co., Ltd | 84025-337 |
| 5% Minoxidil for Men and Women | Biotin .05 g/100g; Tocopherol .05 g/100g | SprayCutaneous | Guangzhou Yanxi Biotechnology Co., Ltd | 84025-332 |
| 5% Minoxidil Hair Growth | Biotin .1 g/100g + 3 more ingredients | SprayCutaneous | Guangzhou Yanxi Biotechnology Co., Ltd | 84025-333 |
| 5% Minoxidil Hair Growth | Minoxidil 5 g/100g + 3 more ingredients | SprayCutaneous | Guangzhou Yanxi Biotechnology Co., Ltd | 84025-334 |
| 5% Signature Numb creamlidocaine | Lidocaine 100 mg/g | CreamCutaneous | Shengnan (Guangzhou) Cosmetics Co., LTD | 84019-026 |
| 5% Signature Numb cream5% signature | Lidocaine 100 mg/g | CreamCutaneous | Shengnan (Guangzhou) Cosmetics Co., LTD | 84019-027 |
| 5% Signature Numb cream5% lidocaine | Lidocaine 100 mg/g | CreamCutaneous | Shengnan (Guangzhou) Cosmetics Co., LTD | 84019-029 |
| 70% Isopropyl Rubbing Alcoholisopropyl alcohol | Isopropyl alcohol 70 mL/100mL | LiquidTopical | MY IMPORTS USA LLC | 51628-4501 |
| 911allantoin | Allantoin .5 g/100g | OintmentTopical | Skinfix, Inc. | 61328-120 |
| A and Dpetrolatum | Petrolatum 76 g/100g | OintmentTopical | Safetec of America, Inc. | 61010-4405 |
Showing 20 of 40.