Over-the-counter drug · OTC MONOGRAPH DRUG
REMEDY Calazime Skin Protectant NDC 53329-165
calamine, menthol, white petrolatum, zinc oxide · Ferric oxide red .5 g/100g + 3 more ingredients · Paste · Topical · Medline Industries, LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53329-165-02 | 5332901650253329016502 | 3 TUBE in 1 BAG (53329-165-02) / 113 g in 1 TUBE (53329-165-44)Marketed from Jul 1, 2021 | |
| 53329-165-44 | 5332901654453329016544 | 113 g in 1 TUBE (53329-165-44)Marketed from Mar 14, 2018 |
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)
- REMEDY Calazime Skin Protectant
- Generic name (nonproprietary)
- calamine, menthol, white petrolatum, zinc oxide
- Active ingredients
- Ferric oxide red — .5 g/100gMenthol — .2 g/100gZinc oxide — 19.5 g/100gPetrolatum — 69 g/100g
- Dosage form
- Paste
- Route
- Topical
- Labeler
- Medline Industries, LPNDC labeler code 53329
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 015
- Marketing start
- Marketing end
- Identifiers
- Product ID 53329-165_42658b90-1277-f5db-e063-6294a90a2460SPL ID 42658b90-1277-f5db-e063-6294a90a2460SPL set ID 1295cfcc-5b61-481b-964b-f53ffd0cb58eRxCUI 1921772UNII 1K09F3G675, L7T10EIP3A, SOI2LOH54Z, 4T6H12BN9U
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
N453329016502followed by a unit qualifier and the quantityPackage 53329-0165-02. 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 Provides temporary relief from skin irritations, itching and discomfort in the perianal area For the temporary relief of pain May provide a cooling sensation
Excerpt only. Read the full label for complete information.
About NDC 53329-165
- What is NDC 53329-165?
- 53329-165 is the product NDC for REMEDY Calazime Skin Protectant, Ferric oxide red .5 g/100g + 3 more ingredients paste, listed with the FDA by Medline Industries, LP. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- REMEDY Calazime Skin Protectant (Calamine, menthol, white petrolatum, zinc oxide).
- What is the active ingredient?
- Ferric oxide red, Menthol, Zinc oxide, Petrolatum.
- Who is the labeler?
- Medline Industries, LP, NDC labeler code 53329. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for REMEDY Calazime Skin Protectant?
- 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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