What is NDC 65197-811?

65197-811 is the product NDC for Bactine Max, Benzalkonium chloride .13 g/100mL; Lidocaine hydrochloride 4 g/100mL liquid, listed with the FDA by WellSpring Pharmaceutical Corporation. It has 2 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Bactine Max (Benzalkonium chloride and lidocaine hydrochloride).

What is the active ingredient?

Benzalkonium chloride, Lidocaine hydrochloride.

WellSpring Pharmaceutical Corporation, NDC labeler code 65197. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Bactine Max?

2 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Bactine Max NDC 65197-811 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65197-811Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65197-0811Add 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
65197-811-14	6519708111465197081114	118 mL in 1 BOTTLE, PLASTIC (65197-811-14)Marketed from Jan 17, 2021
65197-811-15	6519708111565197081115	148 mL in 1 BOTTLE (65197-811-15)Marketed from Jun 22, 2018

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): Bactine Max
Generic name (nonproprietary): benzalkonium chloride and lidocaine hydrochloride
Active ingredients: Benzalkonium chloride — .13 g/100mLLidocaine hydrochloride — 4 g/100mL
Dosage form: Liquid
Route: Topical
Labeler: WellSpring Pharmaceutical CorporationNDC labeler code 65197
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 003
Marketing start: Jun 22, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Amides (Chemical structure)Local Anesthesia (Physiologic effect)
Identifiers: Product ID 65197-811_ec2ae48c-3497-4a66-a88c-4838a37ad3dfSPL ID ec2ae48c-3497-4a66-a88c-4838a37ad3dfSPL set ID 28e8a311-20a4-45a1-8d5d-ca42b101c275RxCUI 2047877, 2047879UNII F5UM2KM3W7, V13007Z41AUPC 0365197811151, 0365197811144
Pharmacologic class: Amide Local Anesthetic; Antiarrhythmic

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

N465197081114 followed by a unit qualifier and the quantity

Package 65197-0811-14. 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 Feb 24, 2021.

Indications (excerpt from the label)

Uses first aid to help prevent bacterial contamination or skin infection, and for temporary relief of pain and itching associated with minor: cuts scrapes minor burns sunburn minor skin irritations

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65197-811

What is NDC 65197-811?: 65197-811 is the product NDC for Bactine Max, Benzalkonium chloride .13 g/100mL; Lidocaine hydrochloride 4 g/100mL liquid, listed with the FDA by WellSpring Pharmaceutical Corporation. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Bactine Max (Benzalkonium chloride and lidocaine hydrochloride).
What is the active ingredient?: Benzalkonium chloride, Lidocaine hydrochloride.
Who is the labeler?: WellSpring Pharmaceutical Corporation, NDC labeler code 65197. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Bactine Max?: 2 other product NDCs are listed under this name. See all Bactine Max NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Bactine Max NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Bactine Maxbactine max wound wash	Benzalkonium chloride .13 g/100mL	LiquidCutaneous	WellSpring Pharmaceutical Corporation	65197-820	65197-0820-80
Bactine Maxlidocaine	Lidocaine hydrochloride 4 g/100mL	LiquidTopical	WellSpring Pharmaceutical Corporation	65197-832	65197-0832-03

Other NDCs under M 003

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

FDA NDC Directory listings under M 003
Product	Strength	Form · route	Labeler	Product NDC
Hydrating Hand Sanitizer ALOE BREEZEalcohol 75%	Alcohol .75 g/mL	LiquidTopical	Guangzhou Ailizhuangsi Cosmetics Co., Ltd.	87910-005
palm partyalcohol hand sanitizer	Alcohol 60 mL/100mL	SprayTopical	Dongyang Loulee Cosmetics Co.,Ltd.	87322-1169
Isopropyl Alcohol	Isopropyl alcohol 70 mL/100mL	ClothTopical	Sarnova, Inc.	81085-0002
Terramed Just Think Comfort Armor Antibacterial Cleansing Barbenzalkonium chloride	Benzalkonium chloride .13 g/100g	SoapTopical	Rida LLC	83004-033
Antiseptic Povidone Iodine Prep Padpovidone-iodine	Povidone-iodine 100 mg/g	ClothTopical	M-star (Hubei) Health&Care Products Co., Ltd.	84219-006
Green Guard Antiseptic Wipesbenzalkonium chloride	Benzalkonium chloride 1.3 mg/mL	SwabTopical	UniFirst First Aid Corporation	47682-206
RITE AID Maximum strength pain relievingbenzalkonium chloride and lidocaine hydrochloride	Benzalkonium chloride .13 g/100mL; Lidocaine hydrochloride 4 g/100mL	LiquidTopical	RITE AID	11822-7220
Obstetrical Towelettebenzalkonium chloride	Benzalkonium chloride 1.3 mg/g	ClothTopical	Jianerkang Medical Co., Ltd	34645-0015
Hand Sanitizer	Alcohol 70 mL/100mL	GelExtracorporeal	Zhejiang Meimi Technology Co., Ltd.	41366-053
50 percent Isopropyl alcoholisopropyl alcohol	Isopropyl alcohol 50 mL/100mL	LiquidTopical	Whole Foods Market	42681-6573
Antibacterial Hand wipesbenzalkonium chloride	Benzalkonium chloride .13 g/100g	ClothTopical	MY IMPORTS USA LLC	51628-9999
E-2 Hand Item 1095chloroxylenol	Chloroxylenol .3 g/100mL	SoapTopical	AMERICAN CHEMICAL AND SANITARY SUPPLY INC	50536-195
Smart Care Kids Hand Sanitizer Peppa pigalcohol	Alcohol 70 mL/100mL	SprayTopical	Shenzhen Lantern Scicence Co.,Ltd.	54860-513
Be Smart Get Prepared Alcohol Prep Padisopropyl alcohol	Isopropyl alcohol .7 mL/mL	ClothTopical	Total Resources International, Inc	55550-242
McKesson Alcohol Prep Padisopropyl alcohol	Isopropyl alcohol .7 mL/mL	SwabTopical	McKesson Medical-Surgical	68599-5804
AshleyBelle Moisturizing Hand Sanitizer Citrus Groveethyl alcohol 70%	Alcohol 70 mL/100mL	SprayTopical	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	75742-041
Mistify Pumpkin Hand Sanitizeralcohol antiseptic	Alcohol 62 mL/100mL	LiquidTopical	Kingkey MBC Life Technology Group Co.,Ltd	73928-313
Hydrogen Peroxide	Hydrogen peroxide 30 mg/mL	SolutionTopical	Grocery Outlet, Inc.	85828-871
Antiseptic Towelette TOALLITAS ANTISEPTICASbenzalkonium chloride	Benzalkonium chloride 1.3 mg/g	ClothTopical	M-star (Hubei) Health&Care Products Co., Ltd.	84219-004
Isopropyl alcohol	Isopropyl alcohol 70 mL/100mL	LiquidTopical	Nice-Pak Products, LLC	11344-845

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