NDC codes

FDA NDC Directory
Product NDC (as listed)76420-253Labeler and product segments. Claims need a package NDC.
Product NDC at billing width76420-0253Add 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
76420-253-0476420025304764200253041 TUBE in 1 BOX (76420-253-04) / 99.2 g in 1 TUBEMarketed from Jul 19, 2022

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)
Lidothol
Generic name (nonproprietary)
lidocaine hcl, menthol
Active ingredients
Menthol — 5 g/100gLidocaine hydrochloride — 4.5 g/100g
Dosage form
Gel
Route
Topical
Labeler
Asclemed USA, Inc.NDC labeler code 76420
Product type
Prescription drug
Marketing category
Unapproved drug (other)
Marketing start
Listing expires
Other FDA classes
Amides (Chemical structure)Local Anesthesia (Physiologic effect)
Identifiers
Product ID 76420-253_e837dbef-8ea9-e5cb-e053-2995a90a8ec8SPL ID e837dbef-8ea9-e5cb-e053-2995a90a8ec8SPL set ID 6d7adaca-67dd-4a4b-a85c-d1c2a568dee2UNII L7T10EIP3A, V13007Z41A
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

N476420025304 followed by a unit qualifier and the quantity

Package 76420-0253-04. 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

Current FDA label (SPL), effective .

Indications (excerpt from the label)

INDICATION AND USAGE Lidothol Gel is indicated for relief of pain associated with arthritis, backache, cramps, discomfort, neckache, soreness, sprains, strains. It should be applied only to intact skin.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76420-253

What is NDC 76420-253?
76420-253 is the product NDC for Lidothol, Menthol 5 g/100g; Lidocaine hydrochloride 4.5 g/100g gel, listed with the FDA by Asclemed USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Lidothol (LIDOCAINE HCl, MENTHOL).
What is the active ingredient?
Menthol, Lidocaine hydrochloride.
Who is the labeler?
Asclemed USA, Inc., NDC labeler code 76420. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Lidothol?
4 other product NDCs are listed under this name. See all Lidothol 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 Lidothol NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Lidothollidocaine hcl, mentholMenthol 5 g/100g; Lidocaine hydrochloride 4.5 g/100gGelCutaneousAdvanced Rx of Tennessee, LLC80425-051680425-0516-01
Lidothollidocaine hcl, mentholMenthol 5 g/100g; Lidocaine hydrochloride 4.5 g/100gGelCutaneousClinic Pharma83881-45583881-0455-35
Lidothollidocaine hcl, mentholMenthol 5 g/100g; Lidocaine hydrochloride 4.5 g/100gGelCutaneousASCLEMED USA INC.87063-21887063-0218-99
Lidothollidocaine and mentholMenthol 1 mg/100mg; Lidocaine 4 mg/100mgPatchTopicalAdvanced Rx Pharmacy of Tennessee, LLC80425-038580425-0385-01

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