What is NDC 65197-406?

65197-406 is the product NDC for AD Medicated Rash, Mineral oil 30 g/100g; Oatmeal 2 g/100g ointment, listed with the FDA by WellSpring Pharmaceutical Corporation. It has 2 package NDCs, shown above in 10- and 11-digit form.

WellSpring Pharmaceutical Corporation, NDC labeler code 65197. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for AD Medicated Rash?

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.

AD Medicated Rash NDC 65197-406 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65197-406Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65197-0406Add 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
65197-406-15	65197040615	1 TUBE in 1 BOX (65197-406-15) / 42.5 g in 1 TUBEMarketed from Jan 15, 2025
65197-406-52	65197040652	431 g in 1 JAR (65197-406-52)Marketed from Apr 30, 2025

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): AD Medicated Rash
Generic name (nonproprietary): ad medicated rash
Active ingredients: Mineral oil — 30 g/100gOatmeal — 2 g/100g
Dosage form: Ointment
Route: Topical
Labeler: WellSpring Pharmaceutical CorporationNDC labeler code 65197
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 016
Marketing start: Jan 15, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Allergens (Chemical structure)Cell-mediated Immunity (Physiologic effect)Dietary Proteins (Chemical structure)Grain Proteins (EXT)Increased Histamine Release (Physiologic effect)Plant Proteins (Chemical structure)
Identifiers: Product ID 65197-406_8fd6a4a0-06b0-4006-b00c-b910dfeb6d7bSPL ID 8fd6a4a0-06b0-4006-b00c-b910dfeb6d7bSPL set ID aac345bf-ea66-4f5b-a497-c24ea72f93eaRxCUI 2710836UNII T5L8T28FGP, 8PI54V663Y
Pharmacologic class: Non-Standardized Food Allergenic Extract; Non-Standardized Plant Allergenic Extract

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

N465197040615 followed by a unit qualifier and the quantity

Package 65197-0406-15. 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 Dec 27, 2024.

Indications (excerpt from the label)

Uses Temporarily protects and helps relieve minor skin irritation and itching due to: rashes eczema

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65197-406

What is NDC 65197-406?: 65197-406 is the product NDC for AD Medicated Rash, Mineral oil 30 g/100g; Oatmeal 2 g/100g ointment, listed with the FDA by WellSpring Pharmaceutical Corporation. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: AD Medicated Rash.
What is the active ingredient?: Mineral oil, Oatmeal.
Who is the labeler?: WellSpring Pharmaceutical Corporation, NDC labeler code 65197. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for AD Medicated Rash?: 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
Product	Strength	Form · route	Labeler	Product NDC
Puriya Eczema Creamcolloidal oatmeal	Oatmeal 1 g/100g	CreamTopical	IPC Republic, Inc.	84711-002
Publix Calamine Medicatedzinc acetate and pramoxine hydrochloride	Zinc oxide 80 mg/mL; Pramoxine hydrochloride 10 mg/mL	LotionTopical	Publix	41415-420
Baby Eczema Therapycolloidal oatmeal	Oatmeal 10.4 kg/g	CreamTopical	Old East Main Co.	55910-803
Baza Protectzinc oxide and dimethicone	Zinc oxide 120 mg/g; Dimethicone, Unspecified 10 mg/g	CreamTopical	Coloplast Corp	11701-082
Leader Calamine Pluszinc oxide lotion	Zinc oxide 80 mg/mL; Pramoxine hydrochloride 10 mg/mL	LotionTopical	Cardinal Health, 110 dba Leader	70000-0400
EELHOE Wart Removerglycerin	Safflower .004 mg/20mg; Arnica montana flower .004 mg/20mg	OintmentTopical	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	85064-005
DR.TEEN Day Time Repairallantoin dimethicone glycerin	Dimethicone 2 g/100g + 2 more ingredients	LiquidTopical	Guangzhou Oulan Cosmetics Co., Ltd.	87964-002
Pure Petrolatum Jellypetrolatum	Petrolatum 100 g/100g	JellyTopical	MY IMPORTS USA LLC	51628-4249
XtraCare Oatmeal Daily Moisturizing 8 ozdimethicone	Dimethicone 1.3 g/100g	LotionTopical	Rejoice International Inc.	57337-139
Geri Care Medicated Padswitch hazel	Witch hazel 50 mg/mL	PatchTopical	Geri-Care Pharmaceuticals, Corp	57896-115
Target Up and Up Petroleum Jellywhite petrolatum	Petrolatum 100 g/100g	JellyTopical	TARGET CORPORATION	11673-132
Sween 24dimethicone	Dimethicone, Unspecified 60 mg/g	CreamTopical	Coloplast Corp	11701-063
Dovedove care and protect antibacterial nourishing foaming hand wash	Benzalkonium chloride 1.3 mg/mL	LiquidTopical	Conopco Inc. d/b/a/ Unilever	64942-1848
Seedlings Diaper Rash Creamzinc oxide	Zinc oxide 140 mg/g	CreamTopical	Young Living Essential Oils, LC.	70631-039
DCH Scarallantoin 0.5%	Allantoin .5 g/100g	GelTopical	Derma Care Research Labs, LLC	72839-097
EELHOE Tanning Mistglycerin	Fragaria ananassa (Strawberry) fruit .02 mg/100mg; Calendula officinalis flower .02 mg/100mg	LiquidTopical	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	85064-006
Blistex Ivarest Poison Ivy Itchzinc acetate and pramoxine hydrochloride	Zinc acetate .12 g/100mL; Pramoxine hydrochloride 1 g/100mL	SprayTopical	Blistex Inc.	10157-2100
Kidgets Baby Petroleum Jellybaby petroleum jelly	Petrolatum 99.9 g/100g	JellyTopical	MY IMPORTS USA LLC	51628-4250
Critic Aid Clearpetrolatum	Petrolatum 710 mg/g	OintmentTopical	Coloplast Corp	11701-066
Vaselineclinical care hand sanitizer lotion	Benzalkonium chloride 1.3 mg/mL	LotionTopical	Conopco Inc. d/b/a/ Unilever	64942-1849

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