NDC codes

FDA NDC Directory
Product NDC (as listed)10223-0221Labeler and product segments. Claims need a package NDC.
Product NDC at billing width10223-0221Add 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
10223-0221-110223022101102230221011 JAR in 1 BOX (10223-0221-1) / 32 g in 1 JARMarketed from Jan 1, 1960

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Cetacaine Topical Anesthetic
Generic name (nonproprietary)
benzocaine, butamben, and tetracaine hydrochloride
Active ingredients
Benzocaine — .028 g/.2gButamben — .004 g/.2gTetracaine hydrochloride — .004 g/.2g
Dosage form
Gel
Route
Topical
Labeler
Cetylite Industries, Inc.NDC labeler code 10223
Product type
Prescription drug
Marketing category
Unapproved drug (other)
Marketing start
Listing expires
Other FDA classes
Allergens (Chemical structure)Cell-mediated Immunity (Physiologic effect)Esters (Chemical structure)Increased Histamine Release (Physiologic effect)Local Anesthesia (Physiologic effect)
Identifiers
Product ID 10223-0221_5e116134-85fa-4b04-9795-d55a361b07deSPL ID 5e116134-85fa-4b04-9795-d55a361b07deSPL set ID 9777acbb-8166-4734-9932-dc66b05bfcb5RxCUI 209970, 308645UNII U3RSY48JW5, 5NF5D4OPCI, EFW857872Q
Pharmacologic class
Ester Local Anesthetic; Standardized Chemical Allergen

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

N410223022101 followed by a unit qualifier and the quantity

Package 10223-0221-01. 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)

Indications Cetacaine Topical Anesthetic Gel is a topical anesthetic indicated for the production of anesthesia of all accessible mucous membrane except the eyes. Cetacaine Topical Anesthetic Gel is indicated for use to control pain and for use for surgical or endoscopic procedures, or other procedures in the ear, nose, mouth, pharynx, larynx, trachea, bronchi, and esophagus. It may also be used for vaginal or rectal procedures where feasible.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 10223-0221

What is NDC 10223-0221?
10223-0221 is the product NDC for Cetacaine Topical Anesthetic, Benzocaine .028 g/.2g + 2 more ingredients gel, listed with the FDA by Cetylite Industries, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Cetacaine Topical Anesthetic (Benzocaine, Butamben, and Tetracaine Hydrochloride).
What is the active ingredient?
Benzocaine, Butamben, Tetracaine hydrochloride.
Who is the labeler?
Cetylite Industries, Inc., NDC labeler code 10223. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cetacaine Topical Anesthetic?
1 other product NDC are listed under this name. See all Cetacaine Topical Anesthetic 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 Cetacaine Topical Anesthetic NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Cetacaine Topical Anestheticbenzocaine, butamben, and tetracaine hydrochlorideBenzocaine .028 g/.2g + 2 more ingredientsGelTopicalCetylite Industries, Inc.10223-021710223-0217-03

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