Over-the-counter drug · OTC MONOGRAPH DRUG

EUTHYMOL Extraordinary Pink Whitening (Sodium fluoride) NDC 53208-561

Sodium fluoride 1.6 mg/g · Paste, Dentifrice · Dental · LG H&H Co., Ltd.

NDC codes

FDA NDC Directory
Product NDC (as listed)53208-561Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53208-0561Add 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
53208-561-0653208056106532080561061 TUBE in 1 CARTON (53208-561-06) / 106 g in 1 TUBEMarketed from Sep 18, 2023

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

Generic name (nonproprietary)
sodium fluoride
Active ingredients
Sodium fluoride — 1.6 mg/g
Dosage form
Paste, Dentifrice
Route
Dental
Labeler
LG H&H Co., Ltd.NDC labeler code 53208
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 021
Marketing start
Listing expires
Identifiers
Product ID 53208-561_2c6be574-5ba9-24f4-e063-6294a90ae56fSPL ID 2c6be574-5ba9-24f4-e063-6294a90ae56fSPL set ID 05b1f105-6f75-7a45-e063-6394a90a58bcRxCUI 891775UNII 8ZYQ1474W7

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N453208056106 followed by a unit qualifier and the quantity

Package 53208-0561-06. 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)

Use helps protect against cavities

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 53208-561

What is NDC 53208-561?
53208-561 is the product NDC for EUTHYMOL Extraordinary Pink Whitening, Sodium fluoride 1.6 mg/g paste, dentifrice, listed with the FDA by LG H&H Co., Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
EUTHYMOL Extraordinary Pink Whitening (Sodium Fluoride).
What is the active ingredient?
Sodium fluoride.
Who is the labeler?
LG H&H Co., Ltd., NDC labeler code 53208. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for EUTHYMOL Extraordinary Pink Whitening?
3 other product NDCs are listed under this name. See all EUTHYMOL Extraordinary Pink Whitening 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 EUTHYMOL Extraordinary Pink Whitening NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
EUTHYMOL Extraordinary Pink Whiteningsodium fluorideSodium fluoride 1.6 mg/gPaste, DentifriceDentalLG H&H CO., LTD.53208-56253208-0562-20
EUTHYMOL Extraordinary Pink Whiteningsodium fluorideSodium fluoride 1.6 mg/gPaste, DentifriceDentalTai Guk Pharm. Co., Ltd.43136-50143136-0501-06
EUTHYMOL Extraordinary Pink Whiteningsodium fluorideSodium fluoride 1.6 mg/gPaste, DentifriceDentalTai Guk Pharm. Co., Ltd.43136-50243136-0502-20

Other NDCs under M 021

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

FDA NDC Directory listings under M 021
ProductStrengthForm · routeLabelerProduct NDC
Colgate Strawberry Burstsodium fluorideSodium fluoride 1.1 mg/gGel, DentifriceDentalColgate-Palmolive Company35000-915
Toms Of Maine Whiten Plus Deep Clean Spearmintsodium fluorideSodium fluoride 1.1 mg/gPaste, DentifriceDentalTom's of Maine, Inc.51009-921
Freshen Upsodium fluorideSodium fluoride 24 mg/100gGel, DentifriceDentalMKJ BRANDS LLC77782-015
Alcohol-Free Anticavitysodium fluorideSodium fluoride .1 mg/mLLiquidOralWalmart Inc.79903-279
Crest 3D White Fresh Mintsodium fluorideSodium fluoride 1.5 mg/gPaste, DentifriceDentalProcter & Gamble Manufactura, S. de R.L. de C.V.58933-881
Colgate Sparkling White Cinnamintsodium fluorideSodium fluoride 1.1 mg/gGel, DentifriceDentalColgate-Palmolive Company35000-900
Toms Of Maine Wicked Cool Mild Mintsodium monofluorophosphateSodium monofluorophosphate 1 mg/gPaste, DentifriceDentalTom's of Maine, Inc.51009-912
DG health Sensitive Maximum Strengthpotassium nitrate, sodium fluorideSodium fluoride .24 g/100g; Potassium nitrate 5 g/100gPaste, DentifriceDentalDolgencorp, LLC55910-360
GuruNanda Anticavitysodium fluorideSodium fluoride .2 mg/mLMouthwashOralGURUNANDA, LLC70708-927
Equate Optimal Care TP Equate Optimal Care TPstannous fluorideStannous fluoride .16 g/100gPaste, DentifriceOralWalmart Inc.79903-280
Crest 3D White Stain Eraser Icy Clean Mintsodium fluorideSodium fluoride 1.5 mg/gPaste, DentifriceDentalProcter & Gamble Manufacturing Mxico, S. de R.L. de C.V.58933-932
Colgate Max Fresh Cool Mintsodium fluorideSodium fluoride 1.1 mg/gGel, DentifriceDentalColgate-Palmolive Company35000-903
Toms of Maine Whiten Plus Deep Clean Peppermintsodium fluorideSodium fluoride 1.1 mg/gPaste, DentifriceDentalTom's of Maine51009-920
Equate Pro-Advanced TP Equate Pro-Advanced TPstannous fluorideStannous fluoride .16 g/100gPaste, DentifriceOralWalmart Inc.79903-281
COLGATE Great Regular Flavorsodium monofluorophosphateSodium monofluorophosphate 1 mg/gPaste, DentifriceDentalColgate-Palmolive Company35000-913
Crest Complete plus Whiteningsodium fluorideSodium fluoride 1.5 mg/gPaste, DentifriceDentalThe Procter & Gamble Manufacturing Company69423-894
Eversmile OrthoFoam Anticavity0.05% sodium fluoride rinseSodium fluoride .05 g/100mLLiquidDentalEverbrands, Inc.72655-600
Crest Premium Plus Deep Clean Active Foam plus Whitening Foaming Mintsodium fluorideSodium fluoride 1.5 mg/gPaste, DentifriceDentalThe Procter & Gamble Manufacturing Company84126-662
Therabreath Healthy Gumsstannous fluorideStannous fluoride .454 g/100gPaste, DentifriceOralChurch & Dwight Co., Inc.10237-271
Crest 3D White Brilliance Charcoalsodium fluorideSodium fluoride 1.5 mg/gPaste, DentifriceDentalProcter & Gamble Manfuacturing Company37000-989

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