What is NDC 65197-827?

65197-827 is the product NDC for Bactine Max Antibiotic and Lidocaine Max Pain Relief, Lidocaine hydrochloride .04 g/g + 2 more ingredients ointment, listed with the FDA by WellSpring Pharmaceutical Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Bactine Max Antibiotic and Lidocaine Max Pain Relief (Lidocaine).

What is the active ingredient?

Lidocaine hydrochloride, Bacitracin zinc, Polymyxin b sulfate.

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 Antibiotic and Lidocaine Max 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.

NDC 65197-827

NDC codes

FDA NDC Directory

Product NDC (as listed)65197-827Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65197-0827Add 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
65197-827-05	6519708270565197082705	1 TUBE in 1 BOX (65197-827-05) / 14.2 g in 1 TUBEMarketed from Jan 15, 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): Bactine Max Antibiotic and Lidocaine Max Pain Relief
Generic name (nonproprietary): lidocaine
Active ingredients: Lidocaine hydrochloride — .04 g/gBacitracin zinc — 500 U/gPolymyxin b sulfate — 10000 U/g
Dosage form: Ointment
Route: Topical
Labeler: WellSpring Pharmaceutical CorporationNDC labeler code 65197
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 017
Marketing start: Jan 15, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Amides (Chemical structure)Decreased Cell Wall Synthesis & Repair (Physiologic effect)Local Anesthesia (Physiologic effect)Polymyxins (Chemical structure)
Identifiers: Product ID 65197-827_4b43197b-b1f7-44b3-a750-7b10c685fa9aSPL ID 4b43197b-b1f7-44b3-a750-7b10c685fa9aSPL set ID 71300df9-6113-4f25-93ca-28ad7e7f79deUNII V13007Z41A, 89Y4M234ES, 19371312D4
Pharmacologic class: Amide Local Anesthetic; Antiarrhythmic; Polymyxin-class Antibacterial

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

N465197082705 followed by a unit qualifier and the quantity

Package 65197-0827-05. 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 Jun 8, 2023.

Indications (excerpt from the label)

Uses First aid to help prevent infection in and temporarily relieves pain due to minor cuts scrapes burns

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65197-827

What is NDC 65197-827?: 65197-827 is the product NDC for Bactine Max Antibiotic and Lidocaine Max Pain Relief, Lidocaine hydrochloride .04 g/g + 2 more ingredients ointment, listed with the FDA by WellSpring Pharmaceutical Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Bactine Max Antibiotic and Lidocaine Max Pain Relief (Lidocaine).
What is the active ingredient?: Lidocaine hydrochloride, Bacitracin zinc, Polymyxin b sulfate.
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 Antibiotic and Lidocaine Max 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 017

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

FDA NDC Directory listings under M 017
Product	Strength	Form · route	Labeler	Product NDC
Extra Strength Itch Reliefdiphenhydramine hcl and zinc acetate	Diphenhydramine hydrochloride 20 mg/g; Zinc acetate 1 mg/g	SprayTopical	Meijer Distribution Inc	79481-0598
3X Medicated Toothache and Gum Gelbenzocaine	Benzocaine 20 g/100g + 2 more ingredients	GelOral	Rite Aid	11822-0613
Meijer Pain Relieving Balm Analgesictrolamine salicylate	Trolamine salicylate 10 mg/g	CreamTopical	Meijer Distribution, Inc	41250-356
Ralli Rapid Pain Relief Roll onmenthol	Menthol 100 mg/mL	GelTopical	Troy Manufacturing, Inc.	63936-9527
CVS Health Pain Relievingcamphor (synthetic), menthol (unspecified form), methyl salicylate	Camphor (Synthetic) 28 mg/1 + 2 more ingredients	PatchTransdermal	Natural Essentials, Inc.	66902-280
Pbz Otctripelennamine hcl 1%	Tripelennamine 1 g/100g	CreamTopical	Kingsway Pharmaceuticals dba NFI, LLC	69993-151
Hydrocortisone	Hydrocortisone 1 g/100g	CreamTopical	Henry Schein	0404-0166
American Safety and First Aidhydrocortisone acetate	Hydrocortisone acetate 10 mg/g	CreamTopical	Orazen Inc	71927-015
MyDerm Bite Reliefbenzocaine	Benzocaine 5 g/100g	OintmentTopical	Inspec Solutions LLC.	72667-019
Thera Plus Maximum Strength Hydrocortisonehydrocortisone	Hydrocortisone 10 mg/g	CreamTopical	Fourstar Group USA, Inc	80684-197
Lidocaine 4%	Lidocaine 400 mg/10g	PatchTransdermal	Marcella Health	85096-201
Tough Love Pain Relievinglidocaine hcl	Lidocaine 4 g/100g	CreamTopical	Allure Labs	62742-4222
Stopain Extra Strength Gelmenthol	Menthol 80 mg/mL	GelTopical	Troy Manufacturing, Inc.	63936-9506
Fast Freeze Lidocaine Roll-Onlidocaine hydrochloride, benzyl alcohol	Lidocaine hydrochloride 40 mg/mL; Benzyl alcohol 10 mg/mL	LiquidTopical	Natural Essentials, Inc.	66902-235
Walgreens pain relievinglidocaine 4%	Lidocaine 4 g/100g	Aerosol, SprayTopical	Walgreens	0363-3038
Bikini Zone Medicated Cremelidocaine	Lidocaine 2 g/100g	CreamTopical	Kingsway Pharmaceuticals dba NFI, LLC	69993-043
American Safety First Aidlidocaine hcl	Lidocaine hydrochloride 20 mg/mL	SprayTopical	Orazen Inc	71927-012
ACOLYE Lidocaine Cream Topical Analgesia Creamlidocaine,menthol	Lidocaine 4 g/100g; Menthol 1 g/100g	CreamTopical	Guangdong Aimu Biological Technology Co., Ltd	83566-617
Healmusz Eczemahydrocortisone 1% eczema	Hydrocortisone 1 g/100g	CreamTopical	Jiangxi Yudexi Pharmaceutical Co., LTD	85248-203
ELAIMEI Numbing Creamlidocaine 4%	Lidocaine 4 g/100mL	CreamTopical	Shenzhen Shandian Jingling Technology Co., Ltd.	83804-005

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Bactine Max Antibiotic and Lidocaine Max Pain Relief (Lidocaine) NDC 65197-827