Over-the-counter drug · OTC MONOGRAPH NOT FINAL
Studio 35 External Analgesic Medicated Body (Menthol and zinc oxide) NDC 0363-0552
Menthol 1.5 mg/g; Zinc oxide 10 mg/g · Powder · Topical · Walgreen Co
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-0552-38 | 0036305523800363055238 | 283 g in 1 BOTTLE (0363-0552-38)Marketed from Feb 7, 2017 |
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)
- Studio 35 External Analgesic Medicated Body
- Generic name (nonproprietary)
- menthol and zinc oxide
- Active ingredients
- Menthol — 1.5 mg/gZinc oxide — 10 mg/g
- Dosage form
- Powder
- Route
- Topical
- Labeler
- Walgreen CoNDC labeler code 0363
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph (not final)Application part348
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Copper Ion Absorption (Physiologic effect)
- Identifiers
- Product ID 0363-0552_4807fb60-8d08-6e61-e054-00144ff8d46cSPL ID 4807fb60-8d08-6e61-e054-00144ff8d46cSPL set ID 2dd63063-45c1-4029-99ac-0962a27a5ddcRxCUI 577232UNII L7T10EIP3A, SOI2LOH54ZUPC 0049022964327
- 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
N400363055238followed by a unit qualifier and the quantityPackage 00363-0552-38. 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)
Uses for the temporary relief of pain and itching associated with: minor cuts sunburn insect bites scrapes minor burns minor skin irritations dries the oozing and weeping of poison ivy, poison oak, poison sumac
Excerpt only. Read the full label for complete information.
About NDC 0363-0552
- What is NDC 0363-0552?
- 0363-0552 is the product NDC for Studio 35 External Analgesic Medicated Body, Menthol 1.5 mg/g; Zinc oxide 10 mg/g powder, listed with the FDA by Walgreen Co. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Studio 35 External Analgesic Medicated Body (Menthol and Zinc Oxide).
- What is the active ingredient?
- Menthol, Zinc oxide.
- Who is the labeler?
- Walgreen Co, NDC labeler code 0363. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Studio 35 External Analgesic Medicated Body?
- 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 part348
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 |
|---|---|---|---|---|
| Fire Outbenzocaine and menthol | Benzocaine 200 mg/mL; Menthol, Unspecified form 10 mg/mL | SolutionTopical | Randob Ltd. | 52412-300 |
| MediNumblidocaine | Lidocaine 40 mg/g | CreamTopical | Valekista Limited | 71383-024 |
| Deeveeant Numblidocaine | Lidocaine 40 mg/g | CreamTopical | Valekista Limited | 71383-014 |
| Intensive Healing Eczemahydrocortisone | Hydrocortisone 1.02 g/100g | LotionTopical | Walgreens | 0363-0670 |
| Cirlutonecamphor | Camphor (Synthetic) .6 g/100g | OintmentTopical | Herbal Health LLC | 71917-001 |
| Terocinlidocaine, menthol | Lidocaine 600 mg/1; Menthol, Unspecified form 600 mg/1 | PatchTopical | Preferred Pharmaceuticals, Inc. | 68788-9555 |
| CVS Pain Relieving First Aid Antisepticlidocaine hydrochloride, benzalkonium chloride | Lidocaine hydrochloride .025 g/g; Benzalkonium chloride .0013 g/g | SprayTopical | CVS Pharmacy | 69842-615 |
| New Terocinmethyl salicylate, capsaicin, and menthol | Methyl salicylate 25 g/100mL + 2 more ingredients | LotionTopical | Preferred Pharmaceuticals Inc. | 68788-7821 |
| Rugby Muscle Rub Creammuscle rub cream | Menthol, Unspecified form 100 mg/g; Methyl salicylate 150 mg/g | CreamTopical | Preferred Pharmaceuticals Inc. | 68788-8729 |
| Discount Drug Mart Regular Strength Itch Stoppingdiphenhydramine hydrochloride, zinc acetate | Diphenhydramine hydrochloride 10 mg/g; Zinc acetate 1 mg/g | CreamTopical | Discount Drug Mart | 53943-261 |
| Avedana Cool Hot Icementhol | Menthol 2 g/100g | GelTopical | Unipack, Inc. | 43749-321 |
| Walgreens Camphor Phenol Gelcamphor, phenol | Camphor (Synthetic) 10.8 mg/g; Phenol 4.7 mg/g | GelTopical | Walgreens | 0363-9425 |
| Discount Drug Mart Anti-itchhydrocortisone | Hydrocortisone 1 g/100g | CreamTopical | DISCOUNT DRUG MART, INC. | 53943-269 |
| CVS Sore Muscle Rub Vanishing Scentmenthol | Menthol .025 g/g | CreamTopical | CVS Pharmacy | 69842-712 |
| Fsk-5lidocaine hydrochloride | — | Kit | Water-Jel Technologies | 59898-170 |
| Pure-Aidlidocaine, menthol | Lidocaine 240 mg/1; Menthol, Unspecified form 60 mg/1 | PatchTopical | Kareway Product, Inc. | 67510-0284 |
| Ebsl-5lidocaine hydrochloride | — | Kit | Water-Jel Technologies | 59898-140 |
| Ebss-5lidocaine hydrochloride | — | Kit | Water-Jel Technologies | 59898-160 |
| Soundbodylidocaine, menthol | Lidocaine 40 mg/1; Menthol 10 mg/1 | PatchTopical | Kareway Product, Inc. | 67510-0636 |
| Iwk-5lidocaine hydrochloride | — | Kit | Water-Jel Technologies | 59898-180 |
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