What is NDC 85398-013?

85398-013 is the product NDC for Hermon Balanitis Cream (sulfur 1x hpus), Sulfur 1 [hp_X]/58g; Symphytum officinale whole 1 [hp_X]/58g cream, listed with the FDA by Beautivity LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Hermon Balanitis Cream (Sulfur 1X HPUS).

What is the active ingredient?

Sulfur, Symphytum officinale whole.

Beautivity LLC, NDC labeler code 85398. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Hermon Balanitis Cream?

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.

Hermon Balanitis Cream NDC 85398-013

NDC codes

FDA NDC Directory

Product NDC (as listed)85398-013Labeler and product segments. Claims need a package NDC.

Product NDC at billing width85398-0013Add 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
85398-013-01	8539800130185398001301	58 g in 1 BOTTLE (85398-013-01)Marketed from Sep 15, 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): Hermon Balanitis Cream
Generic name (nonproprietary): sulfur 1x hpus
Active ingredients: Sulfur — 1 [hp_X]/58gSymphytum officinale whole — 1 [hp_X]/58g
Dosage form: Cream
Route: Topical
Labeler: Beautivity LLCNDC labeler code 85398
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 005
Marketing start: Sep 15, 2025
Listing expires: Dec 31, 2026
Identifiers: Product ID 85398-013_3dba4e4b-8225-6a96-e063-6394a90a9129SPL ID 3dba4e4b-8225-6a96-e063-6394a90a9129SPL set ID 3dba4e4b-8224-6a96-e063-6394a90a9129UNII 70FD1KFU70, H8FJJ6KX5YUPC 0199284499775

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

N485398001301 followed by a unit qualifier and the quantity

Package 85398-0013-01. 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 Sep 1, 2025.

Indications (excerpt from the label)

Apply a thin layer to clean, dry skin 1-2 times daily or as needed. For first-time users,test on a small patch of skin before full application. Massage gently until fully absorbed. For bestresults,use after cleansing with the antifungal soap.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 85398-013

What is NDC 85398-013?: 85398-013 is the product NDC for Hermon Balanitis Cream (sulfur 1x hpus), Sulfur 1 [hp_X]/58g; Symphytum officinale whole 1 [hp_X]/58g cream, listed with the FDA by Beautivity LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Hermon Balanitis Cream (Sulfur 1X HPUS).
What is the active ingredient?: Sulfur, Symphytum officinale whole.
Who is the labeler?: Beautivity LLC, NDC labeler code 85398. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Hermon Balanitis Cream?: 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 005

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

FDA NDC Directory listings under M 005
Product	Strength	Form · route	Labeler	Product NDC
Lavender Foot and Shoe Antifungalundecylenic acid 10%	Undecylenic acid 10 g/100mL	SprayTopical	SANSAR, LLC	83691-015
Sefudun Fungal Nail Patchesglycerin	Glycerin .01 g/1	PatchTopical	Shenzhen Shandian Jingling Technology Co., Ltd.	83804-006
Hongo Killertolnaftate	Miconazole nitrate .2 g/10g	Aerosol, SprayTopical	Efficient Laboratories Inc	58593-625
Lights Isopropyl Alcohol Prep Padsisopropyl alcohol	Isopropyl alcohol 70 mL/100mL	SolutionTopical	Lights Medical Manufacture Co., Ltd.	61333-206
Miconazole Nitrate	Miconazole nitrate 20 mg/g	CreamTopical	STRATEGIC SOURCING SERVICES LLC	70677-1000
Tolnaftatemeijer athletes foot liquid spray	Tolnaftate 1.5 g/150g	Aerosol, SprayTopical	Meijer Distribution Inc.	79481-0591
Mint Blast Foot and Shoe Antifungalundecylenic acid 10%	Undecylenic acid 10 g/100mL	SprayTopical	SANSAR, LLC	83691-013
NATURAL CURES FUNGAL NAIL Patchestolnaftate 1% fungal nail patches	Tolnaftate 1 g/1001	PatchTopical	Jiangxi Yudexi Pharmaceutical Co., LTD	85248-202
Benzo Dermabenzoic acid, salicylic acid, sulfur	Salicylic acid 2.5 g/100g + 2 more ingredients	CreamTopical	LABORATORIOS H.G. C.A.	84058-130
SUNMARK MICONAZOLE NITRATE antifungalmiconazole nitrate	Miconazole nitrate 20 mg/g	CreamTopical	Strategic Sourcing Services LLC	49348-689
Hongo Killertolnaftate	Tolnaftate 1 g/100g	PowderTopical	Efficient Laboratories Inc	58593-288
Mycozyl ALtolnaftate	Tolnaftate .3 g/30mL	LiquidTopical	PureTek Corporation	59088-443
Tolnaftate Cream 1%tolnaftate	Tolnaftate 10 mg/g	CreamTopical	Pharmacy Value Alliance, LLC.	68016-152
Citrus Detox Foot and Shoe Antifungalundecylenic acid 10%	Undecylenic acid 10 g/100mL	SprayTopical	SANSAR, LLC	83691-014
Antifungal Ringworm Treatmentmiconazole nitrate	Miconazole nitrate 2 g/100mL	SprayTopical	Rida LLC	83004-030
Jock-Ezeclotrimazole	Clotrimazole 10 mg/g	CreamTopical	Bentlin Products LLC	47832-071
Maximum Strength Antifungal Liquidtolnaftate	Tolnaftate 10 mg/mL	LiquidTopical	Walgreens Company	0363-2026
QualiLife persimmon foot and shoeundecylenic acid	Undecylenic acid 10 g/100mL	SprayTopical	Guangdong Aimu Biological Technology Co., Ltd	83566-618
Terramed Just Think Comfort Armor Antifungal Body Wash Tea Treetolnaftate	Tolnaftate 1 g/100g	GelTopical	Rida LLC	83004-032
Kakalsa TOENAIL FUNGUS TREATMENTundecylenic acid 25% toenail fungus treatment	Undecylenic acid 25 g/100mL	LiquidTopical	Jiangxi Yudexi Pharmaceutical Co., LTD	85248-204

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Hermon Balanitis Cream (Sulfur 1x hpus) NDC 85398-013