Over-the-counter drug · OTC MONOGRAPH DRUG
Prax (Pramoxine hydrochloride) NDC 0496-0748
Pramoxine hydrochloride 10 mg/mL · Lotion · Topical · Ferndale Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0496-0748-03 | 0049607480300496074803 | 237 mL in 1 BOTTLE (0496-0748-03)Marketed from Apr 1, 2012 | |
| 0496-0748-04 | 0049607480400496074804 | 118 mL in 1 BOTTLE (0496-0748-04)Marketed from Apr 1, 2012 | |
| 0496-0748-15 | 0049607481500496074815 | 15 mL in 1 BOTTLE (0496-0748-15)Marketed from Apr 1, 2012 |
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)
- Prax
- Generic name (nonproprietary)
- pramoxine hydrochloride
- Active ingredients
- Pramoxine hydrochloride — 10 mg/mL
- Dosage form
- Lotion
- Route
- Topical
- Labeler
- Ferndale Laboratories, Inc.NDC labeler code 0496
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 015
- Marketing start
- Listing expires
- Identifiers
- Product ID 0496-0748_297a2f2f-8355-6e34-e063-6394a90add60SPL ID 297a2f2f-8355-6e34-e063-6394a90add60SPL set ID 674f0d8b-3d50-42b1-8401-d2967bcdf5cfRxCUI 1246075, 1246076UNII 88AYB867L5UPC 0304960748034
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
N400496074803followed by a unit qualifier and the quantityPackage 00496-0748-03. 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 discomfort and itch in the perianal area
Excerpt only. Read the full label for complete information.
About NDC 0496-0748
- What is NDC 0496-0748?
- 0496-0748 is the product NDC for Prax (pramoxine hydrochloride), Pramoxine hydrochloride 10 mg/mL lotion, listed with the FDA by Ferndale Laboratories, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Prax (Pramoxine hydrochloride).
- What is the active ingredient?
- Pramoxine hydrochloride.
- Who is the labeler?
- Ferndale Laboratories, Inc., NDC labeler code 0496. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Prax?
- 1 other product NDC are listed under this name. See all Prax NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Prax products
Other finished products listed under the same name: strengths, forms and labelers.
Other NDCs under M 015
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
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|---|---|---|---|---|
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| 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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