Over-the-counter drug · OTC MONOGRAPH DRUG
Calamine Plus Pramoxine HCl (Calamine plus spray) NDC 36800-398
Ferric oxide red .345 mg/116g + 2 more ingredients · Aerosol, Spray · Topical · Topco Associates LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)36800-398Labeler and product segments. Claims need a package NDC.
Product NDC at billing width36800-0398Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36800-398-41 | 3680003984136800039841 | 116 g in 1 CANISTER (36800-398-41)Marketed from Jan 1, 2017 |
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)
- Calamine Plus Pramoxine HCl
- Generic name (nonproprietary)
- calamine plus spray
- Active ingredients
- Ferric oxide red — .345 mg/116gZinc oxide — 24.16 mg/116gPramoxine hydrochloride — 2.72 mg/116g
- Dosage form
- Aerosol, Spray
- Route
- Topical
- Labeler
- Topco Associates LLCNDC labeler code 36800
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 017
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Copper Ion Absorption (Physiologic effect)
- Identifiers
- Product ID 36800-398_5c529fcd-903f-5e7d-e063-6394a90a3155SPL ID 5c529fcd-903f-5e7d-e063-6394a90a3155
- Pharmacologic class
- Copper Absorption Inhibitor
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
N436800039841followed by a unit qualifier and the quantityPackage 36800-0398-41. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 36800-398
- What is NDC 36800-398?
- 36800-398 is the product NDC for Calamine Plus Pramoxine HCl (calamine plus spray), Ferric oxide red .345 mg/116g + 2 more ingredients aerosol, spray, 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?
- Calamine Plus Pramoxine HCl (Calamine Plus Spray).
- What is the active ingredient?
- Ferric oxide red, Zinc oxide, Pramoxine hydrochloride.
- 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 Calamine Plus Pramoxine HCl?
- 8 other product NDCs are listed under this name. See all Calamine Plus Pramoxine HCl NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Calamine Plus Pramoxine HCl products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Calamine Plus Pramoxine HClcalamine plus spray | Ferric oxide red 5 mg/g + 2 more ingredients | Aerosol, SprayTopical | HY-VEE, INC | 42507-956 | 42507-0956-01 |
| Calamine Plus Pramoxine HClcalamine plus spray | Ferric oxide red 5 mg/g + 2 more ingredients | Aerosol, SprayTopical | FSA Store Inc. | 81522-959 | 81522-0959-01 |
| Calamine Plus Pramoxine HClcalamine plus spray | Ferric oxide red 5 mg/g + 2 more ingredients | Aerosol, SprayTopical | Target Corporation | 82442-401 | 82442-0401-01 |
| Calamine Plus Pramoxine HClcalamine plus no touch spray | Ferric oxide red 5 mg/g + 2 more ingredients | Aerosol, SprayTopical | Premier Brands of America Inc. | 56104-100 | 56104-0100-10 |
| Calamine Plus Pramoxine HClcalamine plus spray | Ferric oxide red .345 mg/116g + 2 more ingredients | Aerosol, SprayTopical | Premier Brands of America, Inc. | 56104-251 | 56104-0251-00 |
| Calamine Plus Pramoxine HClcalamine plus spray | Ferric oxide red .345 mg/116g + 2 more ingredients | Aerosol, SprayTopical | Kroger Co. | 30142-156 | 30142-0156-06 |
| Calamine Plus Pramoxine HClcalamine plus spray | Ferric oxide red .345 mg/116g + 2 more ingredients | Aerosol, SprayTopical | CVS Pharmacy | 59779-174 | 59779-0174-4159779-0174-65 |
| Calamine Plus Pramoxine HClcalamine plus no-touch | Ferric oxide red .345 mg/177mL + 2 more ingredients | Aerosol, SprayTopical | Walgreens Company | 0363-8588 | 00363-8588-41 |
Other NDCs under M 017
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 |
|---|---|---|---|---|
| Stopain Extra Strength Continuousmenthol | Menthol 80 mg/mL | SprayTopical | Troy Manufacturing, Inc. | 63936-4850 |
| Fast Freeze Pain Relievingmenthol, unspecified form | Menthol, Unspecified form 33 mg/mL | GelTopical | NATURAL ESSENTIALS, INC. | 66902-116 |
| Walgreens Pain Reliefbenzocaine | Benzocaine 200 mg/g | GelOral | Walgreens Company | 0363-5061 |
| Blt 2lidocaine hcl | Lidocaine hydrochloride 4 g/100g | OintmentTopical | CENTURA PHARMACEUTICALS INC | 70372-728 |
| Lidocaine 4% Patchlidocaine 4% | Lidocaine 40 mg/g | PatchTopical | V2 Pharma, LLC | 72835-400 |
| Just Cbd Roll-On Coolingmenthol | Menthol 4 g/100mL | GelTopical | Just Brands LLC | 73647-400 |
| Magsoothium Body Cooling Formulamenthol | Menthol 5 g/100mL | CreamTopical | Ubu/Elements, Inc. | 83262-002 |
| Rapid Reliefpain relief patch camphor 110mg menthol 33mg capsicum extract 22mg | Levomenthol .3 g/100g + 2 more ingredients | PatchTopical | RAPID AID VIET NAM COMPANY LIMITED | 83569-015 |
| Terramed Just Think Comfort Hydrocortisone 1% Creamhydrocortisone | Hydrocortisone 10 mg/g | CreamTopical | Rida LLC | 83004-051 |
| Tktalker Numbingnumbing | Lidocaine 4 g/100g | CreamTopical | Shenzhen Shandian Jingling Technology Co., Ltd. | 83804-113 |
| Herb Street Backache and Sore Muscle Reliefmenthol | Menthol .1 g/g | StickTopical | Balassa Laboratories Inc. | 10107-432 |
| CBD Pain Relief Creamtrolamine salicylate | Trolamine salicylate 100 mg/g | CreamTopical | Allure Labs | 62742-4198 |
| 3X Medicated Toothache and Gum Gelbenzocaine | Benzocaine 20 g/100g + 2 more ingredients | GelOral | Rite Aid | 11822-0613 |
| Hush Anestheticlidocaine | Lidocaine 40 mg/g | GelTopical | HUSH Anesthetic | 49947-002 |
| Jointivatrolamine salicylate 10% | Trolamine salicylate 10 g/100g | CreamTopical | Rising Pharma Holdings, Inc. | 57237-355 |
| Stopain Clinicalmenthol, unspecified form | Menthol, Unspecified form 100 mg/g | GelTopical | Troy Manufacturing, Inc. | 63936-0975 |
| Coralite Lidocaine 4% Flexible Pain Relief Patch 1ctlidocaine pain patch | Lidocaine 40 mg/g | PatchTopical | United Exchange Corp | 65923-579 |
| Desert Harvest RELEVEUMlidocaine | Lidocaine 40 mg/mL | CreamTopical | Desert Harvest Inc. | 69145-201 |
| A Health Itch Relief Gelitch relief gel | Diphenhydramine hydrochloride 2 mg/100mL | GelTopical | Bionpharma, Inc. | 69452-496 |
| Hempvana Maximum Strength Pain Relief Cream 10% Trolamine Salicylatetrolamine salicylate | Trolamine salicylate 10 g/100g | CreamTopical | TELEBRANDS CORP | 73287-032 |
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