What is NDC 63135-581?

63135-581 is the product NDC for Topicaine 5 (lidocaine 5%), Lidocaine 5 g/100g gel, listed with the FDA by ESBA LABORATORIES INC.. It has 3 package NDCs, shown above in 10- and 11-digit form.

ESBA LABORATORIES INC., NDC labeler code 63135. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Topicaine 5?

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.

Topicaine 5 NDC 63135-581 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63135-581Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63135-0581Add 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
63135-581-04	63135058104	113 g in 1 TUBE (63135-581-04)Marketed from Mar 1, 2008
63135-581-10	63135058110	1 TUBE in 1 BOX (63135-581-10) / 10 g in 1 TUBEMarketed from Apr 20, 2003
63135-581-30	63135058130	1 TUBE in 1 BOX (63135-581-30) / 30 g in 1 TUBEMarketed from Apr 20, 2003

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): Topicaine 5
Generic name (nonproprietary): lidocaine 5%
Active ingredients: Lidocaine — 5 g/100g
Dosage form: Gel
Route: Topical
Labeler: ESBA LABORATORIES INC.NDC labeler code 63135
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 015
Marketing start: Apr 20, 2003
Listing expires: Dec 31, 2027
Other FDA classes: Amides (Chemical structure)Local Anesthesia (Physiologic effect)
Identifiers: Product ID 63135-581_47e9cb0c-dbdb-3ee0-e063-6394a90a9052SPL ID 47e9cb0c-dbdb-3ee0-e063-6394a90a9052SPL set ID 15d33ff7-34ed-253d-e054-00144ff88e88RxCUI 1652104, 1652108UNII 98PI200987UPC 0363135581302
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

N463135058104 followed by a unit qualifier and the quantity

Package 63135-0581-04. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

About NDC 63135-581

What is NDC 63135-581?: 63135-581 is the product NDC for Topicaine 5 (lidocaine 5%), Lidocaine 5 g/100g gel, listed with the FDA by ESBA LABORATORIES INC.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Topicaine 5 (Lidocaine 5%).
What is the active ingredient?: Lidocaine.
Who is the labeler?: ESBA LABORATORIES INC., NDC labeler code 63135. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Topicaine 5?: 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 015

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

FDA NDC Directory listings under M 015
Product	Strength	Form · route	Labeler	Product NDC
0.25 % PHENYLEPHRINE HCl HEMORRHOIDALmineral oil, petrolatum, phenylephrine hydrochloride	Mineral oil 14 g/100g + 2 more ingredients	OintmentTopical	Nantong Health & Beyond Hygienic Products Inc.	43473-094
0.25 % PHENYLEPHRINE HCl HEMORRHOIDALmineral oil, petrolatum, phenylephrine hydrochloride	Mineral oil 14 g/100g + 2 more ingredients	OintmentTopical	Universal Distribution Center LLC	52000-438
5% Lidocaine 10g5% lidocaine	Lidocaine 5 g/100g	CreamTopical	Chongqing Mandongzi Technology Co., Ltd	88002-001
Acolye Numbing Cream Anorectal(Hemorrhoidal) Creamlidocaine	Lidocaine 5 g/100g	CreamTopical	Guangzhou Haishi Biological Technology Co., Ltd.	60771-0028
Acolye Numbing Cream Anorectal(Hemorrhoidal) Creamlidocaine	Lidocaine 5 g/100g	CreamTopical	Guangzhou Haishi Biological Technology Co., Ltd.	60771-0029
Acolye Numbing Cream Anorectal(Hemorrhoidal) Creamlidocaine	Lidocaine 5 g/100g	CreamTopical	Guangdong Aimu Biological Technology Co., Ltd	83566-615
Adellina Lidocaine Numbing Cream Anorectal(Hemorrhoidal) Creamlidocaine	Lidocaine 5 g/100g	CreamTopical	Guangzhou Haishi Biological Technology Co., Ltd.	60771-0041
Adellina Lidocaine Numbing Cream Topical Anorectal Creamlidocaine	Lidocaine 5 g/100g	CreamTopical	Guangdong Aimu Biological Technology Co., Ltd	83566-612
Adellina Lidocaine Numbing Cream Topical Anorectal Creamlidocaine	Lidocaine 5 g/100g	CreamTopical	Guangdong Aimu Biological Technology Co., Ltd	83566-614
ADVANCED NUMB Topical Anestheticlidocaine hydrochloride	Lidocaine hydrochloride 50 mg/g	CreamTopical	Uber Scientific, LLC	71131-052
AER Pre-moistened Witch Hazel Padwitch hazel	Witch hazel 500 mg/mL	SolutionRectal, Topical	Birchwood Laboratories LLC	50289-3250
AER Traveler Toweletteaer traveler	Witch hazel .5 g/1	SolutionRectal, Topical	Birchwood Laboratories LLC	50289-4200
Americainebenzocaine	Benzocaine 5.6 g/28g	OintmentTopical	Insight Pharmaceuticals LLC	63736-375
AnievaLClidocaine	Lidocaine .05 g/g	CreamTopical	Blackstone Products, LLC	87798-001
ANIXIKE Numbinglidocaine4% numbing	Lidocaine 4 g/100g	CreamTopical	Jiangxi Yudexi Pharmaceutical Co., LTD	85248-166
Arlun LIDOCAINE Creamlidocaine cream	Lidocaine 5 g/100g	CreamTopical	Guangzhou Jingliang Cosmetics Co., Ltd.	87408-021
Assured Bikini Smooth Creamlidocaine	Lidocaine 2 g/100g	CreamTopical	Zhejiang Jingwei Pharmaceutical Co., Ltd.	55621-011
Asteroidmenthol, petrolatum, zinc oxide	Menthol .098 g/28g + 2 more ingredients	OintmentTopical	HEALTHTEX LIMITED	84107-552
B-SURE Traveler Toweletteb-sure traveler	Witch hazel .5 g/g	SolutionRectal, Topical	Birchwood Laboratories LLC	50289-9250
Barrier Protectant Creambarrier cream	Menthol 1 mg/g; Zinc oxide 200 mg/g	OintmentTopical	Cardinal Health	63517-003

Showing 20 of 40.

Topicaine 5 (Lidocaine 5%) NDC 63135-581