What is NDC 58345-103?

58345-103 is the product NDC for Gel Antiseptico Dermowipe, Alcohol 70 mL/70mL gel, listed with the FDA by Key Qumica S.A. de C.V.. It has 8 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Gel Antiseptico Dermowipe (Gel antiseptico a base de alcohol etilico).

Key Qumica S.A. de C.V., NDC labeler code 58345. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Gel Antiseptico Dermowipe?

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.

Gel Antiseptico Dermowipe NDC 58345-103

NDC codes

FDA NDC Directory

Product NDC (as listed)58345-103Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58345-0103Add 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
58345-103-01	58345010301	12 BOTTLE, PUMP in 1 BOX (58345-103-01) / 300 mL in 1 BOTTLE, PUMPMarketed from Apr 5, 2024
58345-103-02	58345010302	6 BOTTLE, PUMP in 1 BOX (58345-103-02) / 960 mL in 1 BOTTLE, PUMPMarketed from Apr 5, 2024
58345-103-03	58345010303	6 BAG in 1 BOX (58345-103-03) / 800 mL in 1 BAGMarketed from Apr 5, 2024
58345-103-04	58345010304	3 BOTTLE in 1 BOX (58345-103-04) / 1000 mL in 1 BOTTLEMarketed from Apr 5, 2024
58345-103-05	58345010305	4 BOTTLE in 1 BOX (58345-103-05) / 4000 mL in 1 BOTTLEMarketed from Apr 5, 2024
58345-103-06	58345010306	20000 mL in 1 BOTTLE (58345-103-06)Marketed from Apr 5, 2024
58345-103-07	58345010307	3 BOTTLE, PUMP in 1 BOX (58345-103-07) / 1000 mL in 1 BOTTLE, PUMPMarketed from Apr 5, 2024
58345-103-08	58345010308	2 BOTTLE, PUMP in 1 BOX (58345-103-08) / 4000 mL in 1 BOTTLE, PUMPMarketed from Apr 5, 2024

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): Gel Antiseptico Dermowipe
Generic name (nonproprietary): gel antiseptico a base de alcohol etilico
Active ingredients: Alcohol — 70 mL/70mL
Dosage form: Gel
Route: Topical
Labeler: Key Qumica S.A. de C.V.NDC labeler code 58345
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication 505G(a)(3)
Marketing start: Apr 5, 2024
Listing expires: Dec 31, 2026
Identifiers: Product ID 58345-103_2b26aa61-8365-58d9-e063-6294a90ae76bSPL ID 2b26aa61-8365-58d9-e063-6294a90ae76bSPL set ID 15620afc-d6ae-0f34-e063-6294a90a8ad2UNII 3K9958V90MUPC 7503030886277

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

N458345010301 followed by a unit qualifier and the quantity

Package 58345-0103-01. 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 Jan 7, 2025.

Indications (excerpt from the label)

Modo de empleo Uso directo. Aplique el producto en la superficie de sus manos, frote suavemente durante 30 segundos mínimo, y/o hasta que el producto seque por completo.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 58345-103

What is NDC 58345-103?: 58345-103 is the product NDC for Gel Antiseptico Dermowipe, Alcohol 70 mL/70mL gel, listed with the FDA by Key Qumica S.A. de C.V.. It has 8 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Gel Antiseptico Dermowipe (Gel antiseptico a base de alcohol etilico).
What is the active ingredient?: Alcohol.
Who is the labeler?: Key Qumica S.A. de C.V., NDC labeler code 58345. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Gel Antiseptico Dermowipe?: 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 505G(a)(3)

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

FDA NDC Directory listings under 505G(a)(3)
Product	Strength	Form · route	Labeler	Product NDC
Tartar control plus Antisepticeucalyptol, menthol, methyl salicylate, thymol	Eucalyptol .92 mg/mL + 3 more ingredients	MouthwashOral	Topco Associates LLC	76162-855
Chai Latte Scented Clip On Hand Sanitizeralcohol	Alcohol 70 mL/100mL	GelTopical	Fourstar Group USA, Inc.	80684-062
KeriCure Hand Sanitizeralcohol	Alcohol 70 mL/100mL	SprayTopical	Kericure Inc.	78280-304
San-A-Gel	Alcohol 67 mL/100mL	LiquidTopical	Misco Industrial, LLC	82041-693
Alcohol	Alcohol 70 mL/100mL	GelTopical	TARGET CORPORATION INC.	82442-003
Tork Foam Antibacterialbenzalkonium chloride	Benzalkonium chloride .13 g/100mL	SoapTopical	Essity Professional Hygiene North America LLC	49351-104
Hair Growth Foamminoxidil	Minoxidil 5 g/100mL	Aerosol, FoamTopical	Shenzhen Shandian Jingling Technology Co., Ltd.	83804-008
aromatica hair acondicionador romero con minoxidilminoxidil	Minoxidil 2 mg/473mL	RinseTopical	LABORATORIO MK SRL	87022-012
XtraCare Hand Sanitizer Antibacterial Moisturize with Vitamin E and Aloealcohol	Alcohol 70 mL/100mL	GelTopical	Rejoice Industries Canada Inc.	87559-001
Tartar control plus Antisepticeucalyptol, menthol, methyl salicylate, thymol	Eucalyptol .92 mg/mL + 3 more ingredients	MouthwashOral	Nice-Pak Products, LLC	11344-855
PURELL Advanced Instant Hand Sanitizeralcohol	Alcohol .7 mL/mL	LiquidTopical	GOJO Industries, Inc.	21749-807
ATTITUDE Super Leaves Hand Sanitizer Lemon Leavesethyl alcohol	Alcohol 78.8 mL/100mL	SolutionTopical	9055-7588 Quebec Inc. DBA Attitude	61649-293
Peepin It Real Disney Villains Maleficentalcohol	Alcohol 71 mL/100mL	GelTopical	Bath & Body Works, Inc.	62670-7030
Anti Bacterial Hand Gel Champagne In Parisalcohol	Alcohol 71 mL/100mL	GelTopical	Bath & Body Works, Inc.	62670-6769
Smart Care 2 HAND SANITIZERS 1.35 FL OZ (CHAMPAGNE TOAST, SPARKLING POMEGRANATE)ethyl alcohol	—	Kit	Ashtel Studios, Inc.	70108-399
Antibacterial Hand Sanitizerethyl alcohol	Alcohol 620 mg/mL	GelTopical	Zhejiang Ayan Biotech Co.,Ltd.	70412-112
Wet Wipes Antibacterial Hand Wipes, Travel Packbenzethonium chloride	Benzethonium chloride 1.3 mg/mL	ClothTopical	Global Import Sales LLC	72146-037
Alcohol	Alcohol 62 mL/100mL	LiquidTopical	Amazon.com Services LLC	72288-826
Antiseptic Mouthrinseeucalyptol, menthol, methyl salicylate, thymol	Eucalyptol .92 mg/mL + 3 more ingredients	MouthwashOral	Walmart Inc.	49035-072
hair treatmentminoxidil	Minoxidil 1 mg/473mL	CreamTopical	LABORATORIO MK SRL	87022-009

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