Over-the-counter drug · OTC MONOGRAPH DRUG

Medline (Zinc oxide) NDC 53329-768

Zinc oxide 250 mg/mL · Spray · Topical · Medline Industries, LP

NDC codes

FDA NDC Directory
Product NDC (as listed)53329-768Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53329-0768Add 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
53329-768-555332907685559 mL in 1 BOTTLE, SPRAY (53329-768-55)Marketed from Dec 1, 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

Brand name (proprietary)
Medline
Generic name (nonproprietary)
zinc oxide
Active ingredients
Zinc oxide — 250 mg/mL
Dosage form
Spray
Route
Topical
Labeler
Medline Industries, LPNDC labeler code 53329
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 016
Marketing start
Listing expires
Identifiers
Product ID 53329-768_41349255-e0cd-8d71-e063-6394a90a32caSPL ID 41349255-e0cd-8d71-e063-6394a90a32caSPL set ID dae45414-7401-9536-e053-2a95a90a0a86RxCUI 865073UNII SOI2LOH54Z

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

N453329076855 followed by a unit qualifier and the quantity

Package 53329-0768-55. 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 associated with 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 53329-768

What is NDC 53329-768?
53329-768 is the product NDC for Medline (zinc oxide), Zinc oxide 250 mg/mL spray, listed with the FDA by Medline Industries, LP. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Medline (Zinc oxide).
What is the active ingredient?
Zinc oxide.
Who is the labeler?
Medline Industries, LP, NDC labeler code 53329. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Medline?
47 other product NDCs are listed under this name. See all Medline 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 Medline NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
MedlineacetaminophenAcetaminophen 325 mg/1TabletOralMedline Industries, LP53329-19953329-0199-09
MedlineacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralMedline Industries, LP53329-22153329-0221-09
MedlineaspirinAspirin 81 mg/1Tablet, ChewableOralMedline Industries, LP53329-60153329-0601-09
MedlineiburprofenIbuprofen 200 mg/1Tablet, Film coatedOralMedline Industries, LP53329-60353329-0603-09
MedlineacetaminophenAcetaminophen 500 mg/1TabletOralMedline Industries, LP53329-60553329-0605-09
Medlinemiconazole nitrateMiconazole nitrate 20 mg/gOintmentTopicalMedline Industries, LP53329-25653329-0256-1453329-0256-64
MedlineacetaminophenAcetaminophen 500 mg/1TabletOralMedline Industries, LP53329-60453329-0604-30
MedlinedimethiconeDimethicone 1.575 g/100mLCreamTopicalMedline Industries, LP53329-27153329-0271-4453329-0271-86
MedlineaspirinAspirin 81 mg/1Tablet, Delayed releaseOralMedline Industries, LP53329-60053329-0600-67
Medlinewhite petrolatumWhite petrolatum 86.5 g/100gOintmentTopicalMedline Industries, LP53329-25753329-0257-1053329-0257-74

All 48 Medline NDCs

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
Colloidal oatmealOatmeal 10 mg/gCreamTopicalMeijer, Inc.79481-6601
Gold Bond Eczema Relief Medicated Hand Creamcolloidal oatmealOatmeal 2 g/100gCreamTopicalChattem, Inc.41167-0668
Venrockrosemary oilRosmarinus officinalis (Rosemary) leaf oil 55 g/100g; Biotin .001 g/100gOilTopicalGuangzhou Oupeng Cosmetics Co., Ltd85772-0007
First Aid Beauty FAB Ultra Repair Body Skin Protectantcolloidal oatmealOatmeal .5 g/100gLotionTopicalThe Procter & Gamble Manufacturing Company69423-726
AHHH Bite Reliefsodium bicarbonateSodium bicarbonate 5 g/25gGelTopical7827178271-041
Vitacilina Bebe Diaper Rashzinc oxideZinc oxide 400 mg/gOintmentTopicalTaisho Pharmaceutical California Inc.81929-002
Witch HazelWitch hazel 842 mg/mLLiquidTopicalTOP CARE (Topco Associates LLC)36800-039
First Aid Beauty Face and Body Bestsellers Kitcolloidal oatmeal—KitTopicalThe Procter & Gamble Manufacturing Company84126-911
Skin Protectant with 33% Petrolatum Advance Moisturizing CreampetrolatumPetrolatum 33 g/100gCreamTopicalAldermed Inc.87236-011
Theriac Advanced HealinglanolinLanolin 350.8 mg/gOintmentTopicalSheffield Pharmaceuticals LLC11527-325
XtraCare Creamy Petroleum JellypetrolatumPetrolatum 38 g/127gJellyTopicalRejoice International57337-060
Sarnacolloidal oatmealOatmeal 20 mg/mLLotionTopicalCrown Laboratories, Inc.0316-0256
Zinc Oxide 20%zinc oxideZinc oxide .2 g/gOintmentTopicalTrifecta Pharmaceuticals USA69396-021
FIRST AID BEAUTY FAB ULTRA REPAIR SKIN PROTECTANT Kitcolloidal oatmeal—KitTopicalThe Procter & Gamble Manufacturing Company84126-912
ProCure Zinc Oxidezinc oxideZinc oxide 20 g/100gOintmentTopicalTwin Med LLC55681-017
XtraCare Creamy Petroleum JellypetrolatumPetrolatum 38 g/127gJellyTopicalRejoice International57337-061
Zinc Oxide 20%zinc oxideZinc oxide .2 g/gOintmentTopicalTrifecta Pharmaceuticals USA69396-021
Desitin Maximum Strength Zinc Oxide Diaper Rashzinc oxideZinc oxide 400 mg/gPasteTopicalKenvue Brands LLC69968-0396
HydrophorPetrolatum 42 g/100gOintmentTopicalAkron Pharma Inc.71399-5101
Attitude Diaper Cream Zinc Unscentedzinc oxideZinc oxide 15 g/100gStickTopical9055-7588 Quebec Inc. (Attitude)61649-260

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