NDC codes

FDA NDC Directory
Product NDC (as listed)53943-514Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53943-0514Add 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
53943-514-5053943051450539430514501500 mL in 1 BOTTLE, PLASTIC (53943-514-50)Marketed from Nov 1, 2021

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)
Mouthwash
Generic name (nonproprietary)
eucalyptol, menthol, methyl salicylate, thymol
Active ingredients
Methyl salicylate — .6 mg/mLMenthol — .42 mg/mLThymol — .64 mg/mLEucalyptol — .92 mg/mL
Dosage form
Liquid
Route
Oral
Labeler
DISCOUNT DRUG MARTNDC labeler code 53943
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication 505G(a)(3)
Marketing start
Listing expires
Identifiers
Product ID 53943-514_51157b5f-583b-0fdd-e063-6394a90a1e3eSPL ID 51157b5f-583b-0fdd-e063-6394a90a1e3eSPL set ID d00e472f-78f2-3d36-e053-2995a90ac267RxCUI 1043619UNII LAV5U5022Y, L7T10EIP3A, 3J50XA376E, RV6J6604TKUPC 0093351016189

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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N453943051450 followed by a unit qualifier and the quantity

Package 53943-0514-50. 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 to help reduce and prevent plaque and gingivitis.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 53943-514

What is NDC 53943-514?
53943-514 is the product NDC for Mouthwash, Methyl salicylate .6 mg/mL + 3 more ingredients liquid, listed with the FDA by DISCOUNT DRUG MART. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Mouthwash (Eucalyptol, Menthol, Methyl Salicylate, Thymol).
What is the active ingredient?
Methyl salicylate, Menthol, Thymol, Eucalyptol.
Who is the labeler?
DISCOUNT DRUG MART, NDC labeler code 53943. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Mouthwash?
1 other product NDC are listed under this name. See all Mouthwash NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Mouthwash NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Mouthwashmenthol, methyl salicylate, thymolMethyl salicylate .6 mg/mL + 3 more ingredientsLiquidOralOrazen Inc71927-00671927-0006-01

Other NDCs under 505G(a)(3)

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

FDA NDC Directory listings under 505G(a)(3)
ProductStrengthForm · routeLabelerProduct NDC
Pretty Pump Hand SanitizeralcoholAlcohol 600 mL/LSprayTopicalWhisk Products, Inc.65585-489
Protec Hand Sani Gel AntibacterialalcoholAlcohol .7 mL/mLGelTopicalDegasa, S.A. de C.V.67326-006
Foaming Antibacterialbenzalkonium chlorideBenzalkonium chloride 1.3 g/1000mLSolutionTopicalSam's West, Inc.68196-667
Smart Care TEA and TIMBER HAND SANITIZERethyl alcoholAlcohol 70 mL/100mLSprayTopicalAshtel Studios, Inc.70108-199
B-Pure Moisturizing Hand Sanitizer Warm Cashmere ScentedalcoholAlcohol 70 mL/100mLLiquidTopicalFourstar Group USA, Inc.80684-217
VQ Hydrating Hand Sanitizer Frosted Candy ApplealcoholAlcohol 67.5 mL/100mLLiquidTopicalTychea Co.85980-024
BCBG GENERATION HAND SANITIZER DUO - WILD Cherry AND Mango Cherry SCENTethyl alcohol—KitDiamond Life Cosmetics Trading FZCO87247-933
Anti Bacterial Hand Gel GinghamalcoholAlcohol 71 mL/100mLGelTopicalBath & Body Works, Inc.62670-6641
Anti Bacterial Hand Gel Disney Villains Evil QueenalcoholAlcohol 71 mL/100mLGelTopicalBath & Body Works, Inc.62670-6919
Povidone-Iodine Prep Winged Sterile Largepovidone-iodinePovidone-iodine 100 mg/gSpongeTopicalCardinal Health 200, Inc63517-759
Smart-San Hand Sanitizer FoamalcoholAlcohol 74 mL/100mLLiquidTopicalBest Sanitizers, Inc.59900-352
BZK Antiseptic Towelette Sterilebenzalkonium chlorideBenzalkonium chloride 1.3 mg/gClothTopicalJianerkang Medical Co., Ltd34645-0018
Lavender Hand Sanitizing WipesethanolAlcohol 65 mL/100mLClothTopicalWhole Foods Market, Inc.42681-6810
Pacific Blue ultra Antimicrobial Foam Fragrance Freebenzalkonium chlorideBenzalkonium chloride .13 g/100mLSolutionTopicalGeorgia-Pacific Consumer Products54622-316
Zylast Antiseptic Sethyl alcoholAlcohol 760 mL/1000mLLiquidTopicalInnovative BioDefense57362-466
WhiskCare 375alcoholAlcohol 600 mL/LGelTopicalWhisk Products, Inc.65585-375
GuruNanda Healthy Gumscetylpyridinium chlorideCetylpyridinium chloride 1 mg/mLMouthwashOralGURUNANDA, LLC70708-926
Smart Care SWEET AND STILL HAND SANITIZERethyl alcoholAlcohol 70 mL/100mLSprayTopicalAshtel Studios, Inc.70108-192
B-Pure Moisturizing Hand Sanitizer Midnight Freesia ScentedalcoholAlcohol 70 mL/100mLLiquidTopicalFourstar Group USA, Inc.80684-214
RootStim Minoxidil Hair Regrowth TreatmentminoxidilMinoxidil 5 g/100mLLiquidTopicalYITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD83364-025

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