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	5834501030158345010301	12 BOTTLE, PUMP in 1 BOX (58345-103-01) / 300 mL in 1 BOTTLE, PUMPMarketed from Apr 5, 2024
58345-103-02	5834501030258345010302	6 BOTTLE, PUMP in 1 BOX (58345-103-02) / 960 mL in 1 BOTTLE, PUMPMarketed from Apr 5, 2024
58345-103-03	5834501030358345010303	6 BAG in 1 BOX (58345-103-03) / 800 mL in 1 BAGMarketed from Apr 5, 2024
58345-103-04	5834501030458345010304	3 BOTTLE in 1 BOX (58345-103-04) / 1000 mL in 1 BOTTLEMarketed from Apr 5, 2024
58345-103-05	5834501030558345010305	4 BOTTLE in 1 BOX (58345-103-05) / 4000 mL in 1 BOTTLEMarketed from Apr 5, 2024
58345-103-06	5834501030658345010306	20000 mL in 1 BOTTLE (58345-103-06)Marketed from Apr 5, 2024
58345-103-07	5834501030758345010307	3 BOTTLE, PUMP in 1 BOX (58345-103-07) / 1000 mL in 1 BOTTLE, PUMPMarketed from Apr 5, 2024
58345-103-08	5834501030858345010308	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
Bcbgeneration 2 Pc Hand Sanitizer Mist - Mango And Strawberry Scentethyl alcohol	—	Kit	Diamond Life Cosmetics Trading FZCO	87247-927
Touchland Power Mist Hand Sanitizer Lemon Lime Spritzalcohol	Alcohol .7 mL/mL	SprayTopical	Church & Dwight Co., Inc.	10237-106
Touchland Power Mist Hydrating Hand Sanitizer Mango Passionalcohol	Alcohol 70 mL/100mL	SprayTopical	Church & Dwight Co., Inc.	10237-130
tazza JIM WIPESbenzalkonium chloride	Benzalkonium chloride .13 g/100g	ClothTopical	Tazza Brands East, Inc.	76370-0039
Bee Clean - Beeswax Hand Sanitizer - Citrus and Peppermintalcohol	Alcohol 70 mL/100mL	SprayTopical	BeeCleanSpot	81404-001
NatureWell Hydrating Hand Sanitizer Vanilla Daydreamalcohol	Alcohol 70 mL/100mL	LiquidTopical	American Exchange Group	78870-012
Senexon-Sdocusate sodium 50mg and sennosides 8.6mg	Sennosides 8.6 mg/1; Docusate sodium 50 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8331
B Pure Moisturizing Hand Sanitizer Dragon Fruit Bloom Scentedalcohol	Alcohol 70 mL/100mL	LiquidTopical	Fourstar Group USA, Inc.	80684-199
Coolkesi Biotin Conditionerconditioner	Allium cepa whole .008 g/100mL + 5 more ingredients	PasteTopical	Guangdong Bisutang Biotechnology Co., LTD	84753-042
enMotion Antimicrobial with Moisturizers, Tranquil Aloebenzalkonium chloride	Benzalkonium chloride 1.3 mg/mL	SoapTopical	Georgia-Pacific Consumer Products LP	54622-700
CleanBoss Hand Sanitizeralcohol	Alcohol 76 mL/100mL	GelTopical	Innovative Biodefense, Inc	57362-523
Anti Bacterial Hand Gel Pink Peach Blossomalcohol	Alcohol 71 mL/100mL	GelTopical	Bath & Body Works, Inc.	62670-6656
Anti Bacterial Hand Gel Twisted Peppermintalcohol	Alcohol 71 mL/100mL	GelTopical	Bath & Body Works, Inc.	62670-6935
WhiskCare 387benzalkonium chloride	Benzalkonium chloride 1 mg/mL	SolutionTopical	Whisk Products, Inc.	65585-531
Hand Sanitizerethyl alcohol	Alcohol 70 mL/100mL	GelTopical	Biocosmetica Excel Argentina	67623-002
Free and Pure Allergy Relief Dye Freediphenhydramine hcl	Diphenhydramine hydrochloride 25 mg/1	Capsule, Liquid filledOral	WALGREEN COMPANY	0363-1175
Chemstation HACCP Q E2benzalkonium chloride	Benzalkonium chloride 1.2 g/L	LiquidTopical	ChemStation	71212-101
Antibacterial Hand Sanitizeralcohol	Alcohol 620 mg/mL	SprayTopical	TEKWELD SOLUTIONS, INC.	71160-189
VQ Hydrating Hand Sanitizer Spiced Pumpkinalcohol	Alcohol 70 mL/100mL	LiquidTopical	Tychea Co.	85980-014
Bcbgeneration 4 Pc Hand Sanitizers - Cherry Blossom, Brown Sugar Vanilla, Velvet Peach And Ocean Breeze Scentethyl alcohol	—	Kit	Diamond Life Cosmetics Trading FZCO	87247-590

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