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 | 53462091524 | 24 APPLICATOR in 1 PACKAGE (53462-915-24) / 24 g in 1 APPLICATORMarketed from Dec 11, 2023 | |
| 53462-915-50 | 53462091550 | 3 APPLICATOR in 1 PACKAGE (53462-915-50) / 26 g in 1 APPLICATORMarketed from Jan 1, 1990 | |
| 53462-915-51 | 53462091551 | 3 APPLICATOR in 1 PACKAGE (53462-915-51) / 19 g in 1 APPLICATORMarketed from Jan 1, 1990 | |
| 53462-915-80 | 53462091580 | 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 |
|---|---|---|---|---|
| Aloe Vera Petrolatum Jellypetrolatum | Petrolatum 99.35 g/100g | JellyTopical | Shield Line LLC | 52410-1030 |
| ProCure HydroCerinpetrolatum 33% | Petrolatum 33 g/100g | CreamTopical | Twin Med LLC | 55681-027 |
| Boudreauxs Butt Diaper Rash Max Strengthzinc oxide | Zinc oxide 40 g/113g | CreamTopical | Geodis Logistics LLC | 63471-3001 |
| Aveeno Skin Relief Moisturizing Fragrance Freedimethicone | Dimethicone 12 mg/mL | LotionTopical | Kenvue Brands LLC | 69968-0236 |
| Bath Bomb 6-pack (Peppermint)allantoin | Allantoin 3.1 g/555.3g; Sodium bicarbonate 248 g/555.3g | Tablet, SolubleTopical | Carolina Cannabis Creations LLC | 82876-511 |
| First Aid Beauty FAB Ultra Repair Skin Protectant Birthday Hydrationcolloidal oatmeal | Oatmeal .5 g/100g | CreamTopical | The Procter & Gamble Manufacturing Company | 84126-043 |
| Softlips Tropical Coconut Peach Passiondimethicone | Dimethicone 20 mg/g | StickTopical | The Mentholatum Company | 10742-7005 |
| De LA Cruz Diaper Rashallantoin, petrolatum, and zinc oxide | Allantoin 1 g/100g + 2 more ingredients | OintmentTopical | DLC Laboratories, Inc. | 24286-1566 |
| Medicated Body Powdermenthol | Menthol .42 g/283g | PowderTopical | Jell Pharmaceuticals Pvt Ltd | 30400-506 |
| Earth Mama Eczema Creamcolloidal oatmeal | Oatmeal 50 mg/g | CreamTopical | Earth Mama Angel Baby, LLC | 72812-151 |
| ProCure Moisture Barrier1% dimethicone, 12% zinc oxide | Zinc oxide 12 g/100g; Dimethicone 1 g/100g | CreamTopical | Twin Med LLC | 55681-025 |
| Dermaka Infants and Kids Multi Purpose Skin Protectantzinc oxide | Zinc oxide 250 mg/mL | OintmentTopical | Dermaka Skin Products LLC | 82240-014 |
| Bath Bomb 6-pack (Lavender)allantoin | Allantoin 3.1 g/555.3g; Sodium bicarbonate 248 g/555.3g | Tablet, SolubleTopical | Carolina Cannabis Creations LLC | 82876-508 |
| JAYSUING Liquid Wart Flatglycerin | Camellia sinensis seed oil .0006 mg/3mg | LiquidTopical | Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. | 85060-005 |
| Major Medi-Padswitch hazel | Witch hazel 50 g/100g | ClothTopical | Major Pharmaceuticals | 0904-6829 |
| CVS Health Vitamin A and D Skin Protectantlanolin and petrolatum | Lanolin 155 mg/g; Petrolatum 534 mg/g | OintmentTopical | CVS Health | 51316-399 |
| Novita Petrolatum Jelly Pinkpetrolatum | Petrolatum 99.9 g/100g | JellyTopical | Shield Line LLC | 52410-1020 |
| ProCure LanaCarelanolin 50% | Lanolin 50 g/100g | CreamTopical | Twin Med LLC | 55681-026 |
| Diaper Rashzinc oxide | Zinc oxide 130 mg/g | CreamTopical | Valu Merchandisers Company | 63941-226 |
| Bath Bomb 6-pack (Orange)allantoin | Allantoin 3.1 g/560.55g; Sodium bicarbonate 248 g/560.55g | Tablet, SolubleTopical | Carolina Cannabis Creations LLC | 82876-509 |
Showing 20 of 40.