NDC codes

FDA NDC Directory
Product NDC (as listed)36800-512Labeler and product segments. Claims need a package NDC.
Product NDC at billing width36800-0512Add 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
36800-512-29368000512291 TUBE in 1 CARTON (36800-512-29) / 14 g in 1 TUBEMarketed from Mar 5, 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)
TopCare Oral Pain Relief Maximum StrengthSuffix: Maximum Strength
Generic name (nonproprietary)
benzocaine
Active ingredients
Benzocaine — 20 g/100g
Dosage form
Gel
Route
Topical
Labeler
Topco Associates LLCNDC labeler code 36800
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)Increased Histamine Release (Physiologic effect)
Identifiers
Product ID 36800-512_437fcc59-02bc-7d8c-e063-6394a90af1c0SPL ID 437fcc59-02bc-7d8c-e063-6394a90af1c0SPL set ID 835fb6ac-dbb7-5566-e053-2991aa0af5e2RxCUI 238910UNII U3RSY48JW5
Pharmacologic class
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

N436800051229 followed by a unit qualifier and the quantity

Package 36800-0512-29. 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 due to toothaches

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 36800-512

What is NDC 36800-512?
36800-512 is the product NDC for TopCare Oral Pain Relief Maximum Strength, Benzocaine 20 g/100g gel, listed with the FDA by Topco Associates LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
TopCare Oral Pain Relief Maximum Strength (Benzocaine).
What is the active ingredient?
Benzocaine.
Who is the labeler?
Topco Associates LLC, NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for TopCare Oral Pain Relief Maximum Strength?
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 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
365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash AnticavityfluorideFluoride ion .1 mg/mLMouthwashOralWHOLE FOODS42681-0048
3ECARE Dual formula WhiteningToothpaste Refillsodium fluorideSodium fluoride .155 g/100gOintmentSubgingivalHangzhou Namei Zhikang Technology Co., Ltd.87514-002
3x Medicated Mouth Sore GelbenzocaineZinc chloride .15 g/100g + 2 more ingredientsGelOralWalgreens0363-1605
3X Medicated Mouth Sore GelbenzocaineBenzocaine 20 g/100g + 2 more ingredientsGelOralRite Aid11822-6170
3x Medicated Mouth Sore GelbenzocaineMenthol, Unspecified form .1 g/100g + 2 more ingredientsGelOralHEB37808-691
3x Medicated Mouth Sore GelbenzocaineBenzocaine 20 g/100g + 2 more ingredientsGelOralCVS69842-660
3x Medicated Toothache and Gum GelbenzocaineBenzocaine 20 g/100g + 2 more ingredientsGelOralCVS69842-693
4-in-1 Teeth Care PensSodium fluoride .25 g/100gGel, DentifriceTopicalJiangxi Dentalbright Technology Co., Ltd83778-011
4X Medicated Severe Toothache and Gum CreambenzocaineBenzocaine 20 g/100g + 3 more ingredientsCreamOralRite Aid11822-0614
4X Medicated Severe Toothache and Gum GelbenzocaineBenzalkonium chloride .13 g/100g + 3 more ingredientsGelOralRite Aid11822-0615
4x Medicated Toothache and Gum CreambenzocaineBenzocaine 20 g/100g + 3 more ingredientsCreamOralHEB37808-116
4x Medicated Toothache and Gum CreambenzocaineBenzalkonium chloride .13 g/100g + 3 more ingredientsCreamOralCVS69842-631
4x Medicated Toothache and Gum GelbenzocaineMenthol, Unspecified form .5 g/100g + 3 more ingredientsGelOralWalgreens0363-6008
4X Medicated Toothache and Gum GelbenzocaineBenzocaine 20 g/100g + 3 more ingredientsGelOralWalmart49035-569
4x Medicated Toothache and Gum GelbenzocaineBenzocaine 20 g/100g + 3 more ingredientsGel, DentifriceOralPublix Super Markets INC56062-312
4x Medicated Toothache and Gum GelbenzocaineBenzalkonium chloride .13 g/100g + 3 more ingredientsGelOralCVS69842-642
7 Select Oral Pain Maximum Strength ReliefbenzocaineBenzocaine 200 mg/gGelTopical7-ELEVEN, INC.10202-853
ABC Sore Throat Menthol FlavorphenolPhenol 1.4 g/100mLSprayOralAMERISOURCE BERGEN46122-749
AcetaminophenAcetaminophen 160 mg/5mLSuspensionOralNuCare Pharmaceuticals,Inc.68071-4860
Advance Topical Anesthetic GelbenzocaineBenzocaine 200 mg/gGelDentalThe Atlanta Dental Supply Company DBA Advanced Dental Products71347-100

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