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).

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.

Oatmeal Skin Relief Calming . 8oz NDC 57337-100

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 NDC	11-digit (billing)	Package	Copy
57337-100-01	5733701000157337010001	227 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: Mar 7, 2019
Listing expires: Dec 31, 2027
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 Mar 7, 2019.

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
Product	Strength	Form · route	Labeler	Product NDC
CVS Health Diaper Rashzinc oxide	Zinc oxide 400 mg/g	OintmentTopical	CVS Health	69842-058
TriCalm Hydrogelaluminum acetate	Aluminum acetate 2 mg/mL	GelTopical	Modular Thermal Technologies LLC Dba Life Wear Technologies	71207-100
Eczema Care Moisturizing 3 oz.colloidal oatmeal	Oatmeal 10 mg/mL	LotionTopical	Rejoice International Inc.	57337-101
Vitamin A and Dlanolin and petrolatum	Lanolin 15.5 g/100g; Petrolatum 53.4 g/100g	OintmentTopical	Family Dollar Services Inc	55319-103
Balmex Adult Care Rashzinc oxide	Zinc oxide .113 g/g	CreamTopical	Randob Labs,Ltd.	52412-500
MG217 Baby Eczemacolloidal oatmeal	Oatmeal .02 g/g	LotionTopical	Wisconsin Pharmacal Company	68093-5105
MG217 Eczema Facecolloidal oatmeal	Oatmeal .02 g/g	LotionTopical	Wisconsin Pharmacal Company	68093-7245
Natures Choice Vitamins A and Da and d ointment	Petrolatum 99.397 g/100g	OintmentTopical	Unipack, Inc.	43749-230
Astringentcalcium acetate monohydrate and aluminum sulfate tetradecahydrate	Calcium acetate monohydrate 952 mg/2299mg; Aluminum sulfate tetradecahydrate 1347 mg/2299mg	Powder, For solutionTopical	Granulation Technology, Inc.	63561-0178
Petrolatum	Petrolatum 30 g/100g	CreamTopical	Greenbrier International, Inc.	33992-0498
Petrolatum	Petrolatum 30 g/100g	CreamTopical	Greenbrier International, Inc.	33992-0499
Balmex Multi-Purposepetrolatum	Petrolatum 511 mg/g	OintmentTopical	Randob Labs,Ltd.	52412-450
Balmex Diaper Rashzinc oxide	Zinc oxide .113 g/g	CreamTopical	Randob Labs,Ltd.	52412-400
Argan Air Water Bang Essencedimethicone	Dimethicone .01 g/100mL	CreamTopical	Pioom Cosmetic Co.,ltd	70441-0004
Burts Bees Baby Bee Diaper Rashzinc oxide	Zinc oxide 40 g/100g	OintmentTopical	BURT'S BEES, INC.	26052-028

Oatmeal Skin Relief Calming . 8oz (Dimethicone) NDC 57337-100