NDC codes

FDA NDC Directory
Product NDC (as listed)10237-783Labeler and product segments. Claims need a package NDC.
Product NDC at billing width10237-0783Add 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
10237-783-12102370783121 TUBE in 1 CARTON (10237-783-12) / 3.5 g in 1 TUBEMarketed from Nov 1, 2019
10237-783-18102370783181 TUBE in 1 CARTON (10237-783-18) / 5.1 g in 1 TUBEMarketed from Nov 1, 2019
10237-783-42102370783421 TUBE in 1 CARTON (10237-783-42) / 11.9 g in 1 TUBEMarketed from Nov 1, 2019

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)
Orajel 3X Medicated For All Mouth Sores
Generic name (nonproprietary)
benzocaine, menthol, zinc chloride
Active ingredients
Benzocaine200 mg/gMenthol1 mg/gZinc chloride1.5 mg/g
Dosage form
Gel
Route
Topical
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 022
Marketing start
Listing expires
Other FDA classes
Allergens (Chemical structure)Cell-mediated Immunity (Physiologic effect)Decreased Copper Ion Absorption (Physiologic effect)Increased Histamine Release (Physiologic effect)
Identifiers
Product ID 10237-783_45c2f5a1-7e8a-1fbd-e063-6394a90ab88fSPL ID 45c2f5a1-7e8a-1fbd-e063-6394a90ab88fSPL set ID 99b589ac-9833-fb60-e053-2995a90a0935RxCUI 2266762UNII U3RSY48JW5, L7T10EIP3A, 86Q357L16B
Pharmacologic class
Copper Absorption Inhibitor; 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

N410237078312 followed by a unit qualifier and the quantity

Package 10237-0783-12. 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)

Use for the temporary relief of pain associated with canker sores, cold sores, fever blisters, minor irritation or injury of the mouth and gums

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under M 022

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

FDA NDC Directory listings under M 022
ProductStrengthForm · routeLabelerProduct NDC
Finafta MultiOralbenzocaineBenzocaine 7.5 mg/100mLSprayOralEfficient Laboratories Inc.58593-782
DenTek Instant Pain Relief Maximum StrengthbenzocaineBenzocaine 200 mg/mLLiquidDental, TopicalDenTek Oral Care, Inc.60630-078
Astra-dent Topical Anesthetic GelbenzocaineBenzocaine 200 mg/gGelDentalZag Usa Inc71363-102
Pearson Topical AnestheticbenzocaineBenzocaine 200 mg/gGelDentalPearson Dental Supplies INC.43305-0008
Natural Cherry Honey Herb Throat DropsmentholMenthol 2.1 mg/1LozengeOralRicola USA Inc.63667-517
Pearson Topical AnestheticbenzocaineBenzocaine 200 mg/gGelDentalPearson Dental Supplies INC.43305-0009
HurriCaine Topical AnestheticbenzocaineBenzocaine 200 mg/gGelDental, Oral, PeriodontalBeutlich Pharmaceuticals, LLC0283-0622
Astra-dent Topical Anesthetic GelbenzocaineBenzocaine 200 mg/gGelDentalZag Usa Inc71363-100
Toothachepolyhexamethylene biguanide hydrochloridePolihexanide hydrochloride .25 g/100mLSprayTopicalGuchutang Biotechnology (Longyan) Co., Ltd87083-012
Sore Mouth Cleanserhydrogen peroxideHydrogen peroxide 15 mg/mLMouthwashTopicalMeijer, Inc.41250-750
Pearson Topical AnestheticbenzocaineBenzocaine 200 mg/gGelDentalPearson Dental Supplies INC.43305-0010
Cherry Throat DropsmentholMenthol 1.3 mg/1LozengeOralRicola USA Inc.63667-518
Astra-dent Topical Anesthetic GelbenzocaineBenzocaine 200 mg/gGelDentalZag Usa Inc71363-101
EcoDent Ultimate Essential Mouthcare Sparkling Clean Mintsodium bicarbonateSodium bicarbonate 25 mg/mLLiquidOralLotus Brands, Inc.76328-223
Parodontax Active Gum Health Daily Mouthwash Breath Freshenercetylpyridinium chlorideCetylpyridinium chloride 70 mg/mLLiquidOralHaleon US Holdings LLC0135-0652
Patterson Dental Topical AnestheticbenzocaineBenzocaine 200 mg/gGelDentalPatterson Dental50227-1014
Natural Lemon Mint Herb Throat DropsmentholMenthol 1.5 mg/1LozengeOralRicola Ag54305-489
Quality Choice Maximum Strength Oral Pain RelievingbenzocaineBenzocaine 20 g/100gGelTopicalChain Drug Marketing Association Inc63868-953
Kaylaanzero waste refill for toothpasteSodium fluoride .37 mg/440mgTablet, ChewableDentalKaylaan LLC82091-116
Patterson Dental Topical AnestheticbenzocaineBenzocaine 200 mg/gGelDentalPatterson Dental50227-1011

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