NDC codes

FDA NDC Directory
Product NDC (as listed)68828-700Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68828-0700Add 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
68828-700-01688280700011 TUBE in 1 CARTON (68828-700-01) / 50 mL in 1 TUBEMarketed from Dec 29, 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

Generic name (nonproprietary)
dimethicone,zinc oxide
Active ingredients
Dimethicone — 2 g/100mLZinc oxide — 10 g/100mL
Dosage form
Cream
Route
Topical
Labeler
Distribuidora Comercial Jafra, S.A. de C.V.NDC labeler code 68828
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 68828-700_4ced5cfb-b40e-968f-e063-6394a90a80f5SPL ID 4ced5cfb-b40e-968f-e063-6394a90a80f5SPL set ID f09ba452-e1a6-4f45-901f-bb63d4f8e884RxCUI 2562886UNII 92RU3N3Y1O, SOI2LOH54Z
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

N468828070001 followed by a unit qualifier and the quantity

Package 68828-0700-01. 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 chafed skin 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 68828-700

What is NDC 68828-700?
68828-700 is the product NDC for Tender Moments Delicate Baby Diaper Rash Balm, Dimethicone 2 g/100mL; Zinc oxide 10 g/100mL cream, listed with the FDA by Distribuidora Comercial Jafra, S.A. de C.V.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Tender Moments Delicate Baby Diaper Rash Balm (Dimethicone,Zinc oxide).
What is the active ingredient?
Dimethicone, Zinc oxide.
Who is the labeler?
Distribuidora Comercial Jafra, S.A. de C.V., NDC labeler code 68828. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tender Moments Delicate Baby Diaper Rash Balm?
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
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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