NDC codes

FDA NDC Directory
Product NDC (as listed)0187-1660Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00187-1660Add 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
0187-1660-06001871660061 TUBE in 1 CARTON (0187-1660-06) / 170.1 g in 1 TUBEMarketed from Jan 1, 2012

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
TheraSeal
Generic name (nonproprietary)
dimethicone
Active ingredients
Dimethicone — 1.7 g/170.1g
Dosage form
Cream
Route
Topical
Labeler
Bausch Health US, LLCNDC labeler code 0187
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 014
Marketing start
Listing expires
Other FDA classes
Skin Barrier Activity (Physiologic effect)
Identifiers
Product ID 0187-1660_24ade6cc-c3b3-2d87-e063-6394a90afc61SPL ID 24ade6cc-c3b3-2d87-e063-6394a90afc61SPL set ID 2c8dc616-20c1-4d33-8a89-9bcdb22b35c8RxCUI 200010, 826807UNII 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

N400187166006 followed by a unit qualifier and the quantity

Package 00187-1660-06. 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 Helps prevent and temporarily protect chafed, chapped, cracked, dry skin.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0187-1660

What is NDC 0187-1660?
0187-1660 is the product NDC for TheraSeal (dimethicone), Dimethicone 1.7 g/170.1g cream, listed with the FDA by Bausch Health US, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
TheraSeal (Dimethicone).
What is the active ingredient?
Dimethicone.
Who is the labeler?
Bausch Health US, LLC, NDC labeler code 0187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for TheraSeal?
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 014

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under M 014
ProductStrengthForm · routeLabelerProduct NDC
Oftal-Mycin Lubricant Ophthalmiclight mineral, white petrolatumWhite petrolatum 83 g/100g; Light mineral oil 15 g/100gOintmentOphthalmicGRANDALL DISTRIBUTING, LLC48201-301
Ear Drops Majorcarbamide peroxide 6.5%Carbamide peroxide 6.5 g/100mLLiquidAuricular (Otic)Major Pharmaceuticals0904-6627
JAYSUING Silicone Scar GelglycerinCentella asiatica root .006 mg/30mgGelTopicalShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.85060-007
Tech Care Earwax Removal Kitcarbamide peroxide—KitWarner Tech-care Products, LLC69428-003
Clearcanal Ear Wax Softerner Dropscarbamide peroxideCarbamide peroxide 65 mg/mLSolution/ dropsAuricular (Otic)A-S Medication Solutions50090-7426
Tech Care Earwax Removal Dropscarbamide peroxideCarbamide peroxide 65 mg/mLSolution/ dropsAuricular (Otic)Warner Tech-care Products, LLC69428-002
Good Neighbor Pharmacy Earwax Removal Dropscarbamide peroxideCarbamide peroxide 65 mg/mLLiquidTopicalPreferred Pharmaceuticals Inc.68788-8586
Healthy Earscarbide peroxideCarbamide peroxide 6.5 mg/mLSolutionAuricular (Otic)Vitamex USA, Corp69469-650
TopCare Swimmers Ear Dropsisopropyl alcoholIsopropyl alcohol 950 mg/mLLiquidAuricular (Otic)TOPCO ASSOCIATES36800-064
Auro Driisopropyl alcoholIsopropyl alcohol 95 mL/100mLLiquidAuricular (Otic)Insight Pharmaceuticals LLC63736-327
DDM Ear Drops for Swimmersisopropyl alcoholIsopropyl alcohol 950 mg/mLLiquidAuricular (Otic)Discount Drug Mart53943-098
BacitracinBacitracin 500 [USP'U]/gOintmentTopicalNuCare Pharmaceuticals,Inc.68071-5253
Isopropyl AlcoholIsopropyl alcohol 70 mL/100mLSwabTopicalMazza Healthcare, LLC81280-001
Rite Aid Earwax Removal Dropscarbamide peroxideCarbamide peroxide 6.5 g/100mLLiquidTopicalRite Aid11822-6117
DG Health Earwax Removal kitcarbamide peroxide 6.5%Carbamide peroxide 65 mg/mLSolution/ dropsTopicalDOLLAR GENERAL CORPORATION75712-301
Meijer Earwax Removal Dropscarbamide peroxideCarbamide peroxide 65 mg/mLSolution/ dropsAuricular (Otic)Meijer Distribution Inc41250-282
DoloEarcarbamide peroxideCarbamide peroxide 6.5 g/100mLLiquidAuricular (Otic)Pharmadel LLC55758-506
clotrimazoleClotrimazole 1 g/100gCreamTopicalNuCare Pharmaceuticals, Inc.68071-3395
CareOne Earwax Removal Dropscarbamide peroxideCarbamide peroxide 65 mg/mLSolution/ dropsAuricular (Otic)Retail Business Services, LLC72476-838
Debroxcarbamide peroxideCarbamide peroxide 65 mg/mLLiquidAuricular (Otic)Medtech Products Inc.63029-321

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