What is NDC 83650-101?

83650-101 is the product NDC for Oral Gel Oral Pain Relief (benzocaine benzalkonium chloride), Benzocaine 20 g/100g; Benzalkonium chloride .1 g/100g gel, listed with the FDA by Savvy Care and Cosmetics. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Oral Gel Oral Pain Relief (Benzocaine Benzalkonium Chloride).

What is the active ingredient?

Benzocaine, Benzalkonium chloride.

Savvy Care and Cosmetics, NDC labeler code 83650. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Oral Gel Oral Pain Relief?

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.

Oral Gel Oral Pain Relief NDC 83650-101

NDC codes

FDA NDC Directory

Product NDC (as listed)83650-101Labeler and product segments. Claims need a package NDC.

Product NDC at billing width83650-0101Add 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
83650-101-01	83650010101	42.5 g in 1 TUBE (83650-101-01)Marketed from Sep 22, 2023

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): Oral Gel Oral Pain ReliefSuffix: Oral Pain Relief
Generic name (nonproprietary): benzocaine benzalkonium chloride
Active ingredients: Benzocaine — 20 g/100gBenzalkonium chloride — .1 g/100g
Dosage form: Gel
Route: Topical
Labeler: Savvy Care and CosmeticsNDC labeler code 83650
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 022
Marketing start: Sep 22, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Allergens (Chemical structure)Cell-mediated Immunity (Physiologic effect)Increased Histamine Release (Physiologic effect)
Identifiers: Product ID 83650-101_299dca27-d254-e6ea-e063-6394a90a4f74SPL ID 299dca27-d254-e6ea-e063-6394a90a4f74SPL set ID 05ede7e4-5a0a-c942-e063-6294a90a8a24RxCUI 1595155UNII U3RSY48JW5, F5UM2KM3W7
Pharmacologic class: Standardized Chemical Allergen

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

N483650010101 followed by a unit qualifier and the quantity

Package 83650-0101-01. 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 Dec 19, 2024.

Indications (excerpt from the label)

Use ■ for the temporary relief of pain due to toothaches ■ to help protect against infectionin minor oral irritation

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 83650-101

What is NDC 83650-101?: 83650-101 is the product NDC for Oral Gel Oral Pain Relief (benzocaine benzalkonium chloride), Benzocaine 20 g/100g; Benzalkonium chloride .1 g/100g gel, listed with the FDA by Savvy Care and Cosmetics. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Oral Gel Oral Pain Relief (Benzocaine Benzalkonium Chloride).
What is the active ingredient?: Benzocaine, Benzalkonium chloride.
Who is the labeler?: Savvy Care and Cosmetics, NDC labeler code 83650. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Oral Gel Oral Pain Relief?: 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 022

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

FDA NDC Directory listings under M 022
Product	Strength	Form · route	Labeler	Product NDC
Vicks VapoCool SEVERE plus Intense Pain Reliefbenzocaine and menthol	Benzocaine 15 mg/1; Menthol 20 mg/1	LozengeOral	The Procter & Gamble Manufacturing Company	84126-366
HurriCaine Topical Anestheticbenzocaine	Benzocaine 200 mg/g	GelDental, Oral, Periodontal	Beutlich Pharmaceuticals, LLC	0283-0520
HurriCaine Topical Anesthetic Liquidbenzocaine	Benzocaine 200 mg/g	LiquidDental, Oral, Periodontal	Beutlich Pharmaceuticals, LLC	0283-1116
Orajel Rescue Relief Penoral pain reliever	Zinc chloride 1.5 mg/g + 2 more ingredients	GelOral	Church & Dwight Co., Inc.	10237-731
Sensodyne Complete Protectionstannous fluoride	Stannous fluoride 1.1 mg/g	PasteDental	Haleon US Holdings LLC	0135-0573
4x Medicated Toothache and Gum Creambenzocaine	Benzocaine 20 g/100g + 3 more ingredients	CreamOral	HEB	37808-116
Gumsolbenzocaine, zinc chloride	Benzocaine 1.5 g/30mL; Zinc chloride .03 g/30mL	SprayOral	Kramer Novis	52083-714
Oral Pain Reliefbenzocaine	Benzocaine 200 mg/g	GelOral	GERI-CARE PHARMACEUTICAL CORP	57896-139
4x Medicated Toothache and Gum Creambenzocaine	Benzalkonium chloride .13 g/100g + 3 more ingredients	CreamOral	CVS	69842-631
Mouthwashmenthol, methyl salicylate, thymol	Methyl salicylate .6 mg/mL + 3 more ingredients	LiquidOral	Orazen Inc	71927-006
Made by Dentists Enamel Rebuilding Fresh Mintpotassium nitrate, sodium fluoride	Potassium nitrate 50 mg/g; Sodium fluoride 1.5 mg/g	PasteDental	MADE BY DENTISTS INC	75065-028
Made by Dentists Sensitive and Whitening Fresh Mintpotassium nitrate, sodium fluoride	Potassium nitrate 50 mg/g; Sodium fluoride 1.5 mg/g	PasteDental	MADE BY DENTISTS INC	75065-029
UltraCare Anesthetic Gelbenzocaine	Benzocaine 200 mg/g	GelDental, Periodontal, Topical	The Bellport Company, Inc. dba Gingi-Pak	10129-071
Ear Wax Removal Aid Dropscarbamide peroxide	Carbamide peroxide 65 mg/mL	LiquidAuricular (Otic)	BETTER LIVING BRANDS, LLC	21130-793
Sore Throat Relief Cherryphenol	Phenol 1.4 g/100mL	SprayOral	Best Choice (Valu Merchandisers Company)	63941-376
Antiseptic Lil Drug Store Productseucalyptol, menthol, unspecified form, methyl salicylate, and thymol	Eucalyptol .92 mg/mL + 3 more ingredients	LiquidOral	Lil' Drug Store Products, Inc	66715-6861
Benzo-Jelbenzocaine	Benzocaine 200 mg/g	GelDental	Henry Schein Inc.	0404-0033
Kroger Enamel Protection Sensitive Gentle Whiteningpotassium nitrate, sodium fluoride	Potassium nitrate 5 g/100g; Sodium fluoride .15 g/100g	Paste, DentifriceDental	Kroger Company	30142-362
equate Sensitivepotassium nitrate, sodium fluoride	Potassium nitrate 5 g/100g; Sodium fluoride .15 g/100g	Paste, DentifriceDental	Wal-Mart Stores Inc	49035-257
LISTERINE Original Antisepticeucalyptol, menthol, unspecified form, methyl salicylate, and thymol	Eucalyptol .92 mg/mL + 3 more ingredients	MouthwashOral	Kenvue Brands LLC	69968-0400

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Oral Gel Oral Pain Relief (Benzocaine benzalkonium chloride) NDC 83650-101