NDC codes

FDA NDC Directory
Product NDC (as listed)80489-576Labeler and product segments. Claims need a package NDC.
Product NDC at billing width80489-0576Add 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
80489-576-0180489057601804890576011 TUBE in 1 CARTON (80489-576-01) / 20 g in 1 TUBEMarketed from Feb 1, 2022
80489-576-0280489057602804890576021 TUBE in 1 CARTON (80489-576-02) / 45 g in 1 TUBEMarketed from Feb 1, 2022
80489-576-0380489057603804890576031 TUBE in 1 CARTON (80489-576-03) / 49.6 g in 1 TUBEMarketed from Apr 13, 2024

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)
Drs. DIAPER RASH MAXIMUM STRENGTH
Generic name (nonproprietary)
zinc oxide
Active ingredients
Zinc oxide — 10 g/100gDimethicone — 1 g/100g
Dosage form
Cream
Route
Topical
Labeler
OL PHARMA TECH, LLC Drs PHARMACYNDC labeler code 80489
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 016
Marketing start
Listing expires
Other FDA classes
Decreased Copper Ion Absorption (Physiologic effect)Skin Barrier Activity (Physiologic effect)
Identifiers
Product ID 80489-576_56368fba-54cb-5ca0-e063-6394a90a8abfSPL ID 56368fba-54cb-5ca0-e063-6394a90a8abfSPL set ID 161ba174-1b13-83cd-e063-6394a90af19cRxCUI 686403UNII SOI2LOH54Z, 92RU3N3Y1O
Pharmacologic class
Copper Absorption Inhibitor

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

N480489057601 followed by a unit qualifier and the quantity

Package 80489-0576-01. 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 treat and prevent diaper rash protects minor skin irritation due to diaper rash and helps seal out wetness

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80489-576

What is NDC 80489-576?
80489-576 is the product NDC for Drs. DIAPER RASH MAXIMUM STRENGTH, Zinc oxide 10 g/100g; Dimethicone 1 g/100g cream, listed with the FDA by OL PHARMA TECH, LLC Drs PHARMACY. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Drs. DIAPER RASH MAXIMUM STRENGTH (Zinc Oxide).
What is the active ingredient?
Zinc oxide, Dimethicone.
Who is the labeler?
OL PHARMA TECH, LLC Drs PHARMACY, NDC labeler code 80489. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Drs. DIAPER RASH MAXIMUM STRENGTH?
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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