NDC codes

FDA NDC Directory
Product NDC (as listed)0536-1211Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00536-1211Add 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
0536-1211-9500536121195005361211951 TUBE in 1 BOX (0536-1211-95) / 28 g in 1 TUBEMarketed from Aug 19, 2019

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

Generic name (nonproprietary)
dibucaine
Active ingredients
Dibucaine — 10 mg/g
Dosage form
Ointment
Route
Topical
Labeler
Rugby Laboratories Inc.NDC labeler code 0536
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 015
Marketing start
Listing expires
Other FDA classes
Allergens (Chemical structure)Cell-mediated Immunity (Physiologic effect)Increased Histamine Release (Physiologic effect)
Identifiers
Product ID 0536-1211_364c388d-adc9-9763-e063-6294a90a77cdSPL ID 364c388d-adc9-9763-e063-6294a90a77cdSPL set ID f23c8cd1-98f9-41cd-84d4-cf01c2ede29aRxCUI 198601UNII L6JW2TJG99UPC 0305361211950
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

N400536121195 followed by a unit qualifier and the quantity

Package 00536-1211-95. 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 temporarily relieves pain and itching due to hemorrhoids and other anorectal disorders

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0536-1211

What is NDC 0536-1211?
0536-1211 is the product NDC for Dibucaine Topical Anesthetic 1% Hemorrhoidal, Dibucaine 10 mg/g ointment, listed with the FDA by Rugby Laboratories Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Dibucaine Topical Anesthetic 1% Hemorrhoidal (Dibucaine).
What is the active ingredient?
Dibucaine.
Who is the labeler?
Rugby Laboratories Inc., 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 Dibucaine Topical Anesthetic 1% Hemorrhoidal?
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 015

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

FDA NDC Directory listings under M 015
ProductStrengthForm · routeLabelerProduct NDC
Pramoxine Hydrochloride Anorectalpramoxine hydrochloridePramoxine hydrochloride 1 mg/mLLotionTopicalStratus Pharmaceuticals58980-522
Ma Ying Long Musk Hemorrhoidspetrolatum, zinc oxidePetrolatum 779.9 mg/g; Zinc oxide 76 mg/gOintmentTopicalMayinglong Pharmaceutical Group Co., Ltd.68511-997
Mayinglong Hemorrhoidalpetrolatum, zinc oxidePetrolatum 779.9 mg/g; Zinc oxide 76 mg/gOintmentTopicalMayinglong Pharmaceutical Group Co., Ltd.68511-998
hemorrhoidal maximum strength pain reliefglycerin, phenylephrine hcl, pramoxine hcl, white petrolatumGlycerin 14.4 g/100g + 3 more ingredientsCreamTopicalKroger Company30142-944
Preparation Hcocoa butter, phenylephrine hydrochloride, and witch hazel—KitHaleon US Holdings LLC0573-2884
Hemorrhoidalmineral oil, petrolatum, phenylephrine hclMineral oil 14 g/100g + 2 more ingredientsOintmentRectalKroger Company30142-188
rexall hemorrhoidalcocoa butter, phenylephrine hclCocoa butter 2211 mg/1; Phenylephrine hydrochloride 6.5 mg/1SuppositoryRectalDolgencorp Inc55910-279
Witch HazelWitch hazel 860 mg/mLLiquidTopicalCVS Pharmacy, Inc.59779-045
Dermatool Hemorrhoidalglycerin, lidocaine, petrolatum, phenylephrine hclLidocaine 5 g/100g + 3 more ingredientsCreamTopicalPapalo Group LLC84728-413
Acolye Numbing Cream Anorectal(Hemorrhoidal) CreamlidocaineLidocaine 5 g/100gCreamTopicalGuangzhou Haishi Biological Technology Co., Ltd.60771-0028
Hemorrhoid Anestheticmineral oil, petrolatum, phenylephrine hclPetrolatum .749 g/g + 2 more ingredientsOintmentTopicalSavvy Care and Cosmetics83650-110
hemorrhoidalcocoa butter, phenylephrine hclCocoa butter 2211 mg/1; Phenylephrine hydrochloride 6.5 mg/1SuppositoryRectalMeijer Distribution Inc41250-279
Lidocaine Numbing CreamlidocaineLidocaine .05 g/gCreamTopicalShanghai Chuangshi Medical Technology (Group) Co., Ltd.73557-311
RWWXII Deep Numbing Cream(Anorectal Hemorrhoidal Cream)lidocaineLidocaine 5 g/100gCreamTopicalGuangzhou Haishi Biological Technology Co., Ltd.60771-0027
Barrier Protectant Creambarrier creamMenthol 1 mg/g; Zinc oxide 200 mg/gOintmentTopicalCardinal Health63517-003
ER Hemorrhoidphenylephrine hclMineral oil .14 g/g + 2 more ingredientsCreamRectalEVER READY FIRST AID72976-018
ANIXIKE Numbinglidocaine4% numbingLidocaine 4 g/100gCreamTopicalJiangxi Yudexi Pharmaceutical Co., LTD85248-166
Meijer Maximum strength pain relieving cleansingbenzalkonium chloride and lidocaine hydrochlorideBenzalkonium chloride .13 g/100mL; Lidocaine hydrochloride 4 g/100mLLiquidTopicalMEIJER DISTRIBUTION, INC.41250-287
hemorrhoidalglycerin, phenylephrine hcl, pramoxine hcl, white petrolatumGlycerin 14.4 g/100g + 3 more ingredientsCreamTopicalMeijer Distribution Inc41250-944
Equaline Hemorrhoidalcocoa butter, phenylephrine hclCocoa butter 2211 mg/1; Phenylephrine hydrochloride 6.5 mg/1SuppositoryRectalUnited Natural Foods, Inc. dba UNFI41163-279

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