NDC codes

FDA NDC Directory
Product NDC (as listed)0536-1267Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00536-1267Add 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 NDC11-digit (billing)PackageCopy
0536-1267-200053612672015 g in 1 BOX (0536-1267-20)Marketed from Apr 30, 2020

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
4 Lidocaine Topical Anesthetic
Generic name (nonproprietary)
lidocaine
Active ingredients
Lidocaine — 40 mg/g
Dosage form
Cream
Route
Topical
Labeler
RUGBY LABORATORIESNDC labeler code 0536
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 017
Marketing start
Listing expires
Other FDA classes
Amides (Chemical structure)Local Anesthesia (Physiologic effect)
Identifiers
Product ID 0536-1267_389094cf-5a17-0699-e063-6294a90a6791SPL ID 389094cf-5a17-0699-e063-6294a90a6791SPL set ID 63327e57-f4c8-4ae6-9d28-cef8697bbdccRxCUI 1421893UNII 98PI200987UPC 0305361267209
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

N400536126720 followed by a unit qualifier and the quantity

Package 00536-1267-20. 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 .

Indications (excerpt from the label)

Uses temporarily relieves pain and itching due to: minor cuts minor scrapes sunburn minor skin irritations minor burns insect bites

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0536-1267

What is NDC 0536-1267?
0536-1267 is the product NDC for 4 Lidocaine Topical Anesthetic (lidocaine), Lidocaine 40 mg/g cream, listed with the FDA by RUGBY LABORATORIES. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
4 Lidocaine Topical Anesthetic (Lidocaine).
What is the active ingredient?
Lidocaine.
Who is the labeler?
RUGBY LABORATORIES, NDC labeler code 0536. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for 4 Lidocaine Topical Anesthetic?
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
ProductStrengthForm · routeLabelerProduct NDC
Dr.Harry COMFORT ZONE Creamlidocaine 4% phenylephrine hcl 0.25% comfort zone creamPhenylephrine hydrochloride .25 g/100g; Lidocaine 4 g/100gCreamTopicalJiangxi Yudexi Pharmaceutical Co., LTD85248-162
Itch Relief GelDiphenhydramine hydrochloride 2 mg/100mLGelTopicalPharma Nobis, LLC82645-901
CintheralidocaineLidocaine .04 g/gOintmentCutaneousStrand Health Group83295-8000
Trojan Extended PleasurebenzocaineBenzocaine 4.5 g/60mLSprayTopicalChurch & Dwight Co., Inc.10237-200
Lightning Products BURN RELIEFlidocaine hydrochlorideLidocaine hydrochloride 2 g/100mLSprayTopicalNantong Health & Beyond Hygienic Products Inc.43473-070
Methyl SalicylateMethyl salicylate 250 mg/gCreamTopicalAlexso, Inc50488-1015
Pramoxine Itch reliefpramoxine hcl 1%Pramoxine hydrochloride 1 g/100gCreamTopicalCVS51316-141
Hydrocortisone with Aloehydrocortisone cream 1/2%Hydrocortisone .5 g/100gCreamTopicalSun Pharmaceutical Industries, Inc.51672-5335
Biofreeze Mentholmenthol, unspecified formMenthol, Unspecified form .05 g/gPatchTopicalReckitt Benckiser LLC59316-992
Lidocaine HydrochlorideLidocaine hydrochloride 20 mg/gGelTopicalSafetec of America, Inc.61010-5000
Family Care Anti-ItchhydrocortisoneHydrocortisone 1 g/100gCreamTopicalUnited Exchange Corp.65923-494
Hydrocortisonehydrocortisone 1%Hydrocortisone 1 g/100gCreamTopicalPharmacy Value Alliance LLC68016-149
GeriGentle FrostyHeat Pain Relief Patch BackmentholMenthol 50 mg/mLPatchTopicalGeri-Gentle Corporation69771-012
Lidocare Arm, Neck, Leg4% lidocaineLidocaine 11 mg/1PatchTopicalKingsway Pharmaceuticals dba NFI, LLC69993-450
HealthWise Lidocaine Plus Menthol Patchlidocaine and mentholLidocaine 4 g/100g; Menthol 1 g/100gPatchTopicalVeridian Healthcare71101-062
Careland Plantar Fasciitis Hydrogel Pain Patcheslidocaine, mentholLidocaine 40 mg/g; Menthol 10 mg/gPatchTopicalPlanet (Anhui) Pharmaceutical Co., Ltd.75568-017
Reinreude Back Pain Therapycamphor 80mg menthol 24mg capsicum extract 16mg back pain therapyCapsicum 16 mg/1001 + 2 more ingredientsPatchTopicalJiangxi Yudexi Pharmaceutical Co., LTD85248-159
Toast Screamin HotcapsaicinCapsaicin .1 g/100gCreamTopicalIDEAZ, LLC78983-102
PUREGEN LABS Pain Relief 4 LidocainelidocaineLidocaine 40 mg/gPatchTopicalAdvanced Rx LLC80513-814
Good Neighbor Pharmacy Hydrocortisone With Aloe for Sensitive SkinhydrocortisoneHydrocortisone .5 g/100gCreamTopicalAmerisourceBergen24385-190

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