Over-the-counter drug · OTC MONOGRAPH DRUG
Dibucaine Topical Anesthetic 1% Hemorrhoidal (Dibucaine) NDC 0536-1211
Dibucaine 10 mg/g · Ointment · Topical · Rugby Laboratories Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0536-1211-95 | 0053612119500536121195 | 1 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
- Brand name (proprietary)
- Dibucaine Topical Anesthetic 1% Hemorrhoidal
- 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
N400536121195followed by a unit qualifier and the quantityPackage 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.
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.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Hempvana Maximum Strength Pain Relief Topical Anesthetic Platinumlidocaine 5% | Lidocaine 5 g/100g | CreamTopical | Telebrands Corp | 73287-040 |
| Nupharmisto NumbMD LIDOCAINE cream anorectal (hemorrhoidal)lidocaine cream anorectal | Lidocaine 4 g/80g | CreamTopical | EveryMarket Inc | 85833-002 |
| Lidonumblidocaine 5% | Lidocaine .05 g/g | CreamTopical | Rising Pharma Holdings, Inc. | 57237-353 |
| Exchange Select Hemorrhoidalcocoa butter, phenylephrine hcl | Cocoa butter 2211 mg/1; Phenylephrine hydrochloride 6.5 mg/1 | SuppositoryRectal | Army & Air Force Exchange Service | 55301-279 |
| Preparation H Medicated Wipeswitch hazel | Witch hazel 5 g/1 | ClothTopical | Haleon US Holdings LLC | 0573-0557 |
| Lidocaine anorectal creamlidocaine 5% | Lidocaine 5 g/100g | CreamTopical | EveryMarket Inc | 85833-001 |
| hemorrhoidalcocoa butter, phenylephrine hcl | Cocoa butter 2211 mg/1; Phenylephrine hydrochloride 6.5 mg/1 | SuppositoryRectal | Kroger Company | 30142-279 |
| hemorrhoidalcocoa butter, phenylephrine hcl | Cocoa butter 2211 mg/1; Phenylephrine hydrochloride 6.5 mg/1 | SuppositoryRectal | Meijer Distribution Inc | 41250-279 |
| hemorrhoidal maximum strength pain reliefglycerin, phenylephrine hcl, pramoxine hcl, white petrolatum | Glycerin 14.4 g/100g + 3 more ingredients | CreamTopical | Kroger Company | 30142-944 |
| Oxifylidocaine 5% | Lidocaine 50 mg/g | CreamTopical | Weeks & Leo Compnay, INC. | 11383-331 |
| hemorrhoidalglycerin, phenylephrine hcl, pramoxine hcl, white petrolatum | Glycerin 14.4 g/100g + 3 more ingredients | CreamTopical | Publix Super Markets Inc | 56062-944 |
| Black Label B Numblidocaine hydrochloride | Lidocaine hydrochloride 5 g/100mL | SprayTopical | SCALP TECH INC | 82617-103 |
| hemorrhoidalmineral oil, petrolatum, phenylephrine hcl | Mineral oil 14 g/100g + 2 more ingredients | OintmentRectal | Amazon.com Services LLC | 72288-767 |
| The Solutionlidocaine hydrochloride, epinephrine hydrochloride | Lidocaine hydrochloride 5 g/100mL; Epinephrine hydrochloride .01 g/100mL | SprayTopical | SCALP TECH INC | 82617-101 |
| Good Sense Hemorrhoidal Maximum Strength Pain Reliefglycerin, phenylephrine hcl, pramoxine hcl, white petrolatum | Glycerin 14.4 g/100g + 3 more ingredients | CreamTopical | L. Perrigo Company | 0113-0944 |
| The Solution 2.0lidocaine | Lidocaine hydrochloride 5 g/100mL | SprayTopical | SCALP TECH INC | 82617-102 |
| Equaline Hemorrhoidalcocoa butter, phenylephrine hcl | Cocoa butter 2211 mg/1; Phenylephrine hydrochloride 6.5 mg/1 | SuppositoryRectal | United Natural Foods, Inc. dba UNFI | 41163-279 |
| Walgreens Moisture Barriermenthol, and zinc oxide | Menthol .44 g/100g; Zinc oxide 20.6 g/100g | CreamTopical | Walgreen Company | 0363-3680 |
| The Solu Tionlidocaine hydrochloride and epinephrine hydrochloride | Lidocaine hydrochloride 5 g/100mL; Epinephrine hydrochloride .01 g/100mL | Aerosol, FoamTopical | SCALP TECH INC | 82617-110 |
| Maximum Strength Hemorrhoidal Cream with Aloeglycerin, phenylephine hci, pramoxine hci, petrolatum | White petrolatum 15 g/100g + 3 more ingredients | CreamTopical | Chain Drug Marketing Association | 83324-330 |
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