NDC codes

FDA NDC Directory
Product NDC (as listed)57337-100Labeler and product segments. Claims need a package NDC.
Product NDC at billing width57337-0100Add 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
57337-100-015733701000157337010001227 g in 1 BOTTLE (57337-100-01)Marketed from Mar 7, 2019

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)
Oatmeal Skin Relief Calming . 8ozSuffix: 8oz
Generic name (nonproprietary)
dimethicone
Active ingredients
Dimethicone — 3 g/227g
Dosage form
Lotion
Route
Topical
Labeler
Rejoice International Inc.NDC labeler code 57337
Product type
Over-the-counter drug
Marketing category
OTC monograph (final)Application part347
Marketing start
Listing expires
Other FDA classes
Skin Barrier Activity (Physiologic effect)
Identifiers
Product ID 57337-100_8384b028-7b9c-2a7b-e053-2a91aa0a342cSPL ID 8384b028-7b9c-2a7b-e053-2a91aa0a342cSPL set ID 8384dc52-ba36-da3d-e053-2a91aa0a4f40RxCUI 891710UNII 92RU3N3Y1OUPC 0849607065506

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

N457337010001 followed by a unit qualifier and the quantity

Package 57337-0100-01. 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)

Use Help prevent and temporarily protects chafed, chapped, or cracked skin.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 57337-100

What is NDC 57337-100?
57337-100 is the product NDC for Oatmeal Skin Relief Calming . 8oz, Dimethicone 3 g/227g lotion, listed with the FDA by Rejoice International Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Oatmeal Skin Relief Calming . 8oz (Dimethicone).
What is the active ingredient?
Dimethicone.
Who is the labeler?
Rejoice International Inc., NDC labeler code 57337. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Oatmeal Skin Relief Calming . 8oz?
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 part347

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

FDA NDC Directory listings under part347
ProductStrengthForm · routeLabelerProduct NDC
CVS Health Diaper Rashzinc oxideZinc oxide 400 mg/gOintmentTopicalCVS Health69842-058
TriCalm Hydrogelaluminum acetateAluminum acetate 2 mg/mLGelTopicalModular Thermal Technologies LLC Dba Life Wear Technologies71207-100
Eczema Care Moisturizing 3 oz.colloidal oatmealOatmeal 10 mg/mLLotionTopicalRejoice International Inc.57337-101
Vitamin A and Dlanolin and petrolatumLanolin 15.5 g/100g; Petrolatum 53.4 g/100gOintmentTopicalFamily Dollar Services Inc55319-103
Balmex Adult Care Rashzinc oxideZinc oxide .113 g/gCreamTopicalRandob Labs,Ltd.52412-500
MG217 Baby Eczemacolloidal oatmealOatmeal .02 g/gLotionTopicalWisconsin Pharmacal Company68093-5105
MG217 Eczema Facecolloidal oatmealOatmeal .02 g/gLotionTopicalWisconsin Pharmacal Company68093-7245
Natures Choice Vitamins A and Da and d ointmentPetrolatum 99.397 g/100gOintmentTopicalUnipack, Inc.43749-230
Astringentcalcium acetate monohydrate and aluminum sulfate tetradecahydrateCalcium acetate monohydrate 952 mg/2299mg; Aluminum sulfate tetradecahydrate 1347 mg/2299mgPowder, For solutionTopicalGranulation Technology, Inc.63561-0178
PetrolatumPetrolatum 30 g/100gCreamTopicalGreenbrier International, Inc.33992-0498
PetrolatumPetrolatum 30 g/100gCreamTopicalGreenbrier International, Inc.33992-0499
Balmex Multi-PurposepetrolatumPetrolatum 511 mg/gOintmentTopicalRandob Labs,Ltd.52412-450
Balmex Diaper Rashzinc oxideZinc oxide .113 g/gCreamTopicalRandob Labs,Ltd.52412-400
Argan Air Water Bang EssencedimethiconeDimethicone .01 g/100mLCreamTopicalPioom Cosmetic Co.,ltd70441-0004
Burts Bees Baby Bee Diaper Rashzinc oxideZinc oxide 40 g/100gOintmentTopicalBURT'S BEES, INC.26052-028

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