NDC codes

FDA NDC Directory
Product NDC (as listed)53462-915Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53462-0915Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
53462-915-24534620915245346209152424 APPLICATOR in 1 PACKAGE (53462-915-24) / 24 g in 1 APPLICATORMarketed from Dec 11, 2023
53462-915-5053462091550534620915503 APPLICATOR in 1 PACKAGE (53462-915-50) / 26 g in 1 APPLICATORMarketed from Jan 1, 1990
53462-915-5153462091551534620915513 APPLICATOR in 1 PACKAGE (53462-915-51) / 19 g in 1 APPLICATORMarketed from Jan 1, 1990
53462-915-8053462091580534620915808 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

N453462091524 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

FDA NDC Directory listings under M 016
ProductStrengthForm · routeLabelerProduct NDC
2-Pack Facial SerumWater 78.894 g/100mL + 4 more ingredientsLiquidCutaneousGuangzhou Ariel Biotech Co., Ltd.84148-011
2-Pack Facial Serum3-o-ethyl ascorbic acid .5 g/100mL + 3 more ingredientsLiquidCutaneousGuangzhou Ariel Biotech Co., Ltd.84148-012
3M Cavilon Durable BarrierdimethiconeDimethicone 13000 mg/LCreamTopicalSolventum US LLC17518-030
4% 10gTATTOO Numb Cream4% lidocaineLidocaine 100 mg/gCreamCutaneousShengnan (Guangzhou) Cosmetics Co., LTD84019-031
4% TATTOO Numb Cream4% lidocaineLidocaine 100 mg/gCreamCutaneousShengnan (Guangzhou) Cosmetics Co., LTD84019-030
456 Acne Relief Creamniacinamide,salicylic acid,centella asiatica root,coptis chinensis rootSalicylic acid 380 mg/50g + 3 more ingredientsCreamTopicalGuangzhou Senmai Biotechnology Co.,Ltd.84509-111
5% Dr.care Numb creamlidocaineLidocaine 100 mg/gCreamCutaneousShengnan (Guangzhou) Cosmetics Co., LTD84019-028
5% MinoxidilMinoxidil 2 g/100g + 3 more ingredientsSprayCutaneousGuangzhou Yanxi Biotechnology Co., Ltd84025-328
5% MinoxidilMinoxidil 2 g/100g + 3 more ingredientsSprayCutaneousGuangzhou Yanxi Biotechnology Co., Ltd84025-329
5% MinoxidilBiotin .05 g/100g; Niacinamide 2.5 g/100gSprayCutaneousGuangzhou Yanxi Biotechnology Co., Ltd84025-335
5% MinoxidilMinoxidil 5 g/100g + 5 more ingredientsSprayCutaneousGuangzhou Yanxi Biotechnology Co., Ltd84025-337
5% Minoxidil for Men and WomenBiotin .05 g/100g; Tocopherol .05 g/100gSprayCutaneousGuangzhou Yanxi Biotechnology Co., Ltd84025-332
5% Minoxidil Hair GrowthBiotin .1 g/100g + 3 more ingredientsSprayCutaneousGuangzhou Yanxi Biotechnology Co., Ltd84025-333
5% Minoxidil Hair GrowthMinoxidil 5 g/100g + 3 more ingredientsSprayCutaneousGuangzhou Yanxi Biotechnology Co., Ltd84025-334
5% Signature Numb creamlidocaineLidocaine 100 mg/gCreamCutaneousShengnan (Guangzhou) Cosmetics Co., LTD84019-026
5% Signature Numb cream5% signatureLidocaine 100 mg/gCreamCutaneousShengnan (Guangzhou) Cosmetics Co., LTD84019-027
5% Signature Numb cream5% lidocaineLidocaine 100 mg/gCreamCutaneousShengnan (Guangzhou) Cosmetics Co., LTD84019-029
70% Isopropyl Rubbing Alcoholisopropyl alcoholIsopropyl alcohol 70 mL/100mLLiquidTopicalMY IMPORTS USA LLC51628-4501
911allantoinAllantoin .5 g/100gOintmentTopicalSkinfix, Inc.61328-120
A and DpetrolatumPetrolatum 76 g/100gOintmentTopicalSafetec of America, Inc.61010-4405

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