NDC codes

FDA NDC Directory
Product NDC (as listed)53329-165Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53329-0165Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
53329-165-0253329016502533290165023 TUBE in 1 BAG (53329-165-02) / 113 g in 1 TUBE (53329-165-44)Marketed from Jul 1, 2021
53329-165-445332901654453329016544113 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

N453329016502 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

FDA NDC Directory listings under M 015
ProductStrengthForm · routeLabelerProduct NDC
Hempvana Maximum Strength Pain Relief Topical Anesthetic Platinumlidocaine 5%Lidocaine 5 g/100gCreamTopicalTelebrands Corp73287-040
Nupharmisto NumbMD LIDOCAINE cream anorectal (hemorrhoidal)lidocaine cream anorectalLidocaine 4 g/80gCreamTopicalEveryMarket Inc85833-002
Lidonumblidocaine 5%Lidocaine .05 g/gCreamTopicalRising Pharma Holdings, Inc.57237-353
Exchange Select Hemorrhoidalcocoa butter, phenylephrine hclCocoa butter 2211 mg/1; Phenylephrine hydrochloride 6.5 mg/1SuppositoryRectalArmy & Air Force Exchange Service55301-279
Preparation H Medicated Wipeswitch hazelWitch hazel 5 g/1ClothTopicalHaleon US Holdings LLC0573-0557
Lidocaine anorectal creamlidocaine 5%Lidocaine 5 g/100gCreamTopicalEveryMarket Inc85833-001
hemorrhoidalcocoa butter, phenylephrine hclCocoa butter 2211 mg/1; Phenylephrine hydrochloride 6.5 mg/1SuppositoryRectalKroger Company30142-279
hemorrhoidalcocoa butter, phenylephrine hclCocoa butter 2211 mg/1; Phenylephrine hydrochloride 6.5 mg/1SuppositoryRectalMeijer Distribution Inc41250-279
hemorrhoidal maximum strength pain reliefglycerin, phenylephrine hcl, pramoxine hcl, white petrolatumGlycerin 14.4 g/100g + 3 more ingredientsCreamTopicalKroger Company30142-944
Oxifylidocaine 5%Lidocaine 50 mg/gCreamTopicalWeeks & Leo Compnay, INC.11383-331
hemorrhoidalglycerin, phenylephrine hcl, pramoxine hcl, white petrolatumGlycerin 14.4 g/100g + 3 more ingredientsCreamTopicalPublix Super Markets Inc56062-944
Black Label B Numblidocaine hydrochlorideLidocaine hydrochloride 5 g/100mLSprayTopicalSCALP TECH INC82617-103
hemorrhoidalmineral oil, petrolatum, phenylephrine hclMineral oil 14 g/100g + 2 more ingredientsOintmentRectalAmazon.com Services LLC72288-767
The Solutionlidocaine hydrochloride, epinephrine hydrochlorideLidocaine hydrochloride 5 g/100mL; Epinephrine hydrochloride .01 g/100mLSprayTopicalSCALP TECH INC82617-101
Good Sense Hemorrhoidal Maximum Strength Pain Reliefglycerin, phenylephrine hcl, pramoxine hcl, white petrolatumGlycerin 14.4 g/100g + 3 more ingredientsCreamTopicalL. Perrigo Company0113-0944
The Solution 2.0lidocaineLidocaine hydrochloride 5 g/100mLSprayTopicalSCALP TECH INC82617-102
Equaline Hemorrhoidalcocoa butter, phenylephrine hclCocoa butter 2211 mg/1; Phenylephrine hydrochloride 6.5 mg/1SuppositoryRectalUnited Natural Foods, Inc. dba UNFI41163-279
Walgreens Moisture Barriermenthol, and zinc oxideMenthol .44 g/100g; Zinc oxide 20.6 g/100gCreamTopicalWalgreen Company0363-3680
The Solu Tionlidocaine hydrochloride and epinephrine hydrochlorideLidocaine hydrochloride 5 g/100mL; Epinephrine hydrochloride .01 g/100mLAerosol, FoamTopicalSCALP TECH INC82617-110
Maximum Strength Hemorrhoidal Cream with Aloeglycerin, phenylephine hci, pramoxine hci, petrolatumWhite petrolatum 15 g/100g + 3 more ingredientsCreamTopicalChain Drug Marketing Association83324-330

Showing 20 of 40.

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in