What is NDC 58345-106?

58345-106 is the product NDC for Solucion Antiseptica Dermoxine, Chlorhexidine gluconate .97 g/100mL; Alcohol 70 mL/100mL liquid, listed with the FDA by Key Qumica S.A. de C.V.. It has 4 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Solucion Antiseptica Dermoxine (Solucion antiseptica topica a base de alcohol etilico).

What is the active ingredient?

Chlorhexidine gluconate, Alcohol.

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 Solucion Antiseptica Dermoxine?

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.

Solucion Antiseptica Dermoxine NDC 58345-106

NDC codes

FDA NDC Directory

Product NDC (as listed)58345-106Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58345-0106Add 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
58345-106-01	58345010601	12 BOTTLE, PUMP in 1 BOX (58345-106-01) / 500 mL in 1 BOTTLE, PUMPMarketed from Sep 18, 2024
58345-106-02	58345010602	3 BOTTLE in 1 BOX (58345-106-02) / 1000 mL in 1 BOTTLEMarketed from Sep 18, 2024
58345-106-03	58345010603	3 BOTTLE, PUMP in 1 BOX (58345-106-03) / 1000 mL in 1 BOTTLE, PUMPMarketed from Sep 18, 2024
58345-106-04	58345010604	4 BOTTLE in 1 BOX (58345-106-04) / 4000 mL in 1 BOTTLEMarketed from Sep 18, 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): Solucion Antiseptica Dermoxine
Generic name (nonproprietary): solucion antiseptica topica a base de alcohol etilico
Active ingredients: Chlorhexidine gluconate — .97 g/100mLAlcohol — 70 mL/100mL
Dosage form: Liquid
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: Sep 18, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Cell Wall Integrity (Physiologic effect)
Identifiers: Product ID 58345-106_226b154a-8e17-365a-e063-6394a90ae163SPL ID 226b154a-8e17-365a-e063-6394a90ae163SPL set ID 226b154a-8e16-365a-e063-6394a90ae163UNII MOR84MUD8E, 3K9958V90M

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

N458345010601 followed by a unit qualifier and the quantity

Package 58345-0106-01. 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 18, 2024.

Indications (excerpt from the label)

Modo de empleo Directo. Después de un adecuado lavado de manos, aplique el producto sobre las mismas, frote suavemente durante 30 segundos mínimo abarcando toda la superficie (dorso, palmas y antebrazos) hasta que seque por completo. PARA MAYOR INFORMACIÓN CONSULTE LA FICHA TÉCNICA.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 58345-106

What is NDC 58345-106?: 58345-106 is the product NDC for Solucion Antiseptica Dermoxine, Chlorhexidine gluconate .97 g/100mL; Alcohol 70 mL/100mL liquid, listed with the FDA by Key Qumica S.A. de C.V.. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Solucion Antiseptica Dermoxine (Solucion antiseptica topica a base de alcohol etilico).
What is the active ingredient?: Chlorhexidine gluconate, 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 Solucion Antiseptica Dermoxine?: 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
JuniperCleanDishSoap Appledishwashing detergent	Chloroxylenol .2 g/100g	LiquidCutaneous, Topical	KYNC DESIGN LLC	76557-013
NatureWell Hydrating Hand Sanitizer Fresh Squeezealcohol	Alcohol 70 mL/100mL	LiquidTopical	American Exchange Group	78870-008
B Pure Moisturizing Hand Sanitizer Dragon Fruit Bloom Scentedalcohol	Alcohol 70 mL/100mL	LiquidTopical	Fourstar Group USA, Inc.	80684-199
Arthcal 4% Lidocaine Gel Patcheslidocaine	Lidocaine 4 g/100g	PatchExtracorporeal	Beijing JUNGE Technology Co., Ltd.	85212-0005
PUTRIZEN ARNICA BRUISE RELIEF Cream	Arnica montana 15 g/100g	CreamTopical	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	84558-028
VQ Hand Sanitizer Passion Floweralcohol	Alcohol 70 mL/100mL	LiquidTopical	Tychea Co.	85980-040
Advanced Hand Sanitizerethyl alcohol	Alcohol 70 mL/100mL	GelTopical	Topco Associates LLC	36800-898
Alcohol Free Hand Sanitizerbenzalkonium chloride	Benzalkonium chloride 1 mg/mL	Aerosol, FoamTopical	FULLER INDUSTRIES, INC	60933-200
CSI E3 Hand Sanitizeralcohol	Alcohol 70 mL/100mL	LiquidTopical	Central Solutions Inc	62654-139
Anti Bacterial Hand Gel Fresh Amalfi Lemonalcohol	Alcohol 71 mL/100mL	GelTopical	Bath & Body Works, Inc.	62670-6837
Antispeticeucalyptol, menthol, methyl salicylate, thymol	Eucalyptol .92 mg/mL + 3 more ingredients	MouthwashOral	Lidl US, LLC	71141-156
GoodEarth Sanitizing Wipesbenzalkonium chloride	Benzalkonium chloride 3.822 mg/1	ClothTopical	GoodEarth Distribution LLC	71745-003
Juniper Clean Hand Sanitizeralcohol	Alcohol 70 mL/100mL	GelTopical	KYNC Design LLC	76557-000
QIDILA 5% Minoxidil Foamminoxidil,biotin	Minoxidil 5 g/100mL; Biotin 5 g/100mL	Aerosol, FoamExtracorporeal	Beijing JUNGE Technology Co., Ltd.	85212-0002
5% Menthol Pain Relief Patchpain relief patch	Menthol 5 g/100g	PatchTopical	Xuzhou Lanting Pharmaceutical Co., Ltd	85323-006
VQ Hand Sanitizer Citrus Splashalcohol	Alcohol 70 mL/100mL	LiquidTopical	Tychea Co.	85980-037
Lidocaine Pain Relief Gel -Patchlidocaine	Lidocaine .04 g/g	PatchTopical	Guangzhou Sumi Technology Innovation Co., Ltd	87518-185
Ormadus Foodservice Antibacterial Foambenzalkonium chloride	Benzalkonium chloride .13 g/100mL	LiquidTopical	SC Johnson Professional USA Inc	11084-023
Antisepticcetylpyridinium chloride	Cetylpyridinium chloride .7 mg/mL	RinseOral	Topco Associates LLC	36800-299
EcoCare 350isopropyl alcohol	Isopropyl alcohol 80 mL/100mL	SolutionTopical	Ecolab Inc.	47593-363

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