What is NDC 58345-104?

58345-104 is the product NDC for Key Dermoxine Jabon Espuma (jabon antiseptico en espuma), Chlorhexidine gluconate 4.2 g/100mL liquid, listed with the FDA by Key Qumica S.A. de C.V.. It has 2 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Key Dermoxine Jabon Espuma (Jabon Antiseptico en espuma).

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 Key Dermoxine Jabon Espuma?

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.

Key Dermoxine Jabon Espuma NDC 58345-104

NDC codes

FDA NDC Directory

Product NDC (as listed)58345-104Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58345-0104Add 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
58345-104-01	58345010401	3 BOTTLE, PUMP in 1 BOX (58345-104-01) / 1000 mL in 1 BOTTLE, PUMPMarketed from Apr 29, 2024
58345-104-02	58345010402	3 BAG in 1 BOX (58345-104-02) / 1000 mL in 1 BAGMarketed from Apr 29, 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): Key Dermoxine Jabon Espuma
Generic name (nonproprietary): jabon antiseptico en espuma
Active ingredients: Chlorhexidine gluconate — 4.2 g/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: Apr 29, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Cell Wall Integrity (Physiologic effect)
Identifiers: Product ID 58345-104_2b26a872-c29f-8486-e063-6294a90ab023SPL ID 2b26a872-c29f-8486-e063-6294a90ab023SPL set ID 1743684f-647d-0949-e063-6294a90a7d37UNII MOR84MUD8E

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

N458345010401 followed by a unit qualifier and the quantity

Package 58345-0104-01. 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)

Use To decrease bacteria on skin that could cause diseases. Recommend for repeated use.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 58345-104

What is NDC 58345-104?: 58345-104 is the product NDC for Key Dermoxine Jabon Espuma (jabon antiseptico en espuma), Chlorhexidine gluconate 4.2 g/100mL liquid, listed with the FDA by Key Qumica S.A. de C.V.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Key Dermoxine Jabon Espuma (Jabon Antiseptico en espuma).
What is the active ingredient?: Chlorhexidine gluconate.
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 Key Dermoxine Jabon Espuma?: 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
0.025% Capsaicin Pain relief Patchcapsaicin pain relief patch, capsaicin pain relief strip	Capsaicin .025 g/100g	PatchTopical	Xuzhou Lanting Pharmaceutical Co., Ltd	85323-001
0.025% Capsaicin Pain relief Patchcapsaicin pain relief patch, capsaicin pain relief strip	Capsaicin .025 g/100g	PatchTopical	Xuzhou Lanting Pharmaceutical Co., Ltd	85323-005
0.9% Sodium Chloride Saline Solutionsodium chloride	Sodium chloride .009 g/mL	LiquidNasal	Yunqi Cosmetics (Shenzhen) Co., Ltd	84763-012
12-Pack Hand Sanitizerisopropyl alcohol	Isopropyl alcohol 72 mL/100mL	SprayTopical	handetizer, LLC	85782-015
154 Antibacterial Liquid Handchloroxylenol	Chloroxylenol 1 g/L	SoapTopical	Worklife Brands, LLC	80434-701
24 7 life by 7 Eleven Antibacterial HAND WIPESbenzalkonium chloride	Benzalkonium chloride .13 g/100g	ClothTopical	7-ELEVEN, INC.	10202-402
24 7 life by 7 Eleven Instant Hand Sanitizerethyl alcohol	Alcohol 70 mL/100mL	GelTopical	7-ELEVEN, INC.	10202-400
3 in 1 First Aid Wound Carebenzethonium chloride	Benzethonium chloride 1.3 mg/g	SolutionTopical	Rite Aid Corporation	11822-5074
3% Menthol plus 0.083% Capsaicin Pain Relief Patchpain relief patch, pain relief strip	Menthol 3 g/100g; Capsaicin 83 mg/100g	PatchTopical	Xuzhou Lanting Pharmaceutical Co., Ltd	85323-008
365 Spiced Balsam Hand Sanitizer Wipesalcohol hand sanitizer	Alcohol 2.55 mL/1	ClothTopical	Whole Foods Market, Inc.	42681-0041
365 Spiced Citrus Hand Sanitizer Wipesalcohol hand sanitizer	Alcohol 2.55 mL/1	ClothTopical	Whole Foods Market, Inc.	42681-0043
365 Winterberry Saffron Hand Sanitizer Wipesalcohol hand sanitizer	Alcohol 2.55 mL/1	ClothTopical	Whole Foods Market, Inc.	42681-0042
4 IN LOOK Ginseng Anit wrink Anti wrinkle essenceniacinamide	Niacinamide .5 g/100mL	EmulsionTopical	Guangzhou Yanhou Cosmetics Co., Ltd.	85977-001
4% Lidocaine Pain Relief Patchlidocaine pain relief patch	Lidocaine hydrochloride 4 g/100g	PatchTopical	Xuzhou Lanting Pharmaceutical Co., Ltd	85323-002
4% lidocaine plus 1% menthol Pain Relief Patchpain relief patch, pain relief strip	Levomenthol 1 g/100g; Lidocaine hydrochloride 4 g/100g	PatchTopical	Xuzhou Lanting Pharmaceutical Co., Ltd	85323-003
5% Menthol Pain Relief Patchpain relief patch	Levomenthol 5 g/100g	PatchTopical	Xuzhou Lanting Pharmaceutical Co., Ltd	85323-004
5% Menthol Pain Relief Patchpain relief patch	Menthol 5 g/100g	PatchTopical	Xuzhou Lanting Pharmaceutical Co., Ltd	85323-006
5% Menthol Pain Relief Patchpain relief patch	Menthol 5 g/100g	PatchTopical	Xuzhou Lanting Pharmaceutical Co., Ltd	85323-007
5% Minoxidil Foamminoxidil	Minoxidil .05 g/mL	Aerosol, FoamTopical	HONG KONG YUEJIE INTERNATIONAL TRADING LIMITED	87986-001
5% Minoxidil Hair Care Solution	Minoxidil 5 g/100mL	LiquidTopical	Shenzhen Linglong Trading Co., Ltd.	87376-001

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Key Dermoxine Jabon Espuma (Jabon antiseptico en espuma) NDC 58345-104