NDC codes

FDA NDC Directory
Product NDC (as listed)53943-261Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53943-0261Add 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
53943-261-0153943026101539430261011 TUBE in 1 CARTON (53943-261-01) / 28 g in 1 TUBEMarketed from Mar 17, 2014

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

Generic name (nonproprietary)
diphenhydramine hydrochloride, zinc acetate
Active ingredients
Diphenhydramine hydrochloride — 10 mg/gZinc acetate — 1 mg/g
Dosage form
Cream
Route
Topical
Labeler
Discount Drug MartNDC labeler code 53943
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)Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 53943-261_8748d13d-8634-6ab1-e053-2995a90a2580SPL ID 8748d13d-8634-6ab1-e053-2995a90a2580SPL set ID 8748c31d-8258-0357-e053-2a95a90a9c22RxCUI 1292313UNII TC2D6JAD40, FM5526K07A
Pharmacologic class
Copper Absorption Inhibitor; Histamine-1 Receptor Antagonist

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

N453943026101 followed by a unit qualifier and the quantity

Package 53943-0261-01. 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 temporarliy relieves pain and itching due to: insect bites minor burns sunburn minor skin irritations minor cuts scrapes rashes due to poison ivy, poison oak, and poison sumac dries the oozing and weeping due to poison: ivy oak sumac

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 53943-261

What is NDC 53943-261?
53943-261 is the product NDC for Discount Drug Mart Regular Strength Itch Stopping, Diphenhydramine hydrochloride 10 mg/g; Zinc acetate 1 mg/g cream, listed with the FDA by Discount Drug Mart. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Discount Drug Mart Regular Strength Itch Stopping (Diphenhydramine hydrochloride, Zinc acetate).
What is the active ingredient?
Diphenhydramine hydrochloride, Zinc acetate.
Who is the labeler?
Discount Drug Mart, NDC labeler code 53943. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Discount Drug Mart Regular Strength Itch Stopping?
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.

FDA NDC Directory listings under part348
ProductStrengthForm · routeLabelerProduct NDC
Fire Outbenzocaine and mentholBenzocaine 200 mg/mL; Menthol, Unspecified form 10 mg/mLSolutionTopicalRandob Ltd.52412-300
MediNumblidocaineLidocaine 40 mg/gCreamTopicalValekista Limited71383-024
Deeveeant NumblidocaineLidocaine 40 mg/gCreamTopicalValekista Limited71383-014
Intensive Healing EczemahydrocortisoneHydrocortisone 1.02 g/100gLotionTopicalWalgreens0363-0670
CirlutonecamphorCamphor (Synthetic) .6 g/100gOintmentTopicalHerbal Health LLC71917-001
Terocinlidocaine, mentholLidocaine 600 mg/1; Menthol, Unspecified form 600 mg/1PatchTopicalPreferred Pharmaceuticals, Inc.68788-9555
CVS Pain Relieving First Aid Antisepticlidocaine hydrochloride, benzalkonium chlorideLidocaine hydrochloride .025 g/g; Benzalkonium chloride .0013 g/gSprayTopicalCVS Pharmacy69842-615
New Terocinmethyl salicylate, capsaicin, and mentholMethyl salicylate 25 g/100mL + 2 more ingredientsLotionTopicalPreferred Pharmaceuticals Inc.68788-7821
Studio 35 External Analgesic Medicated Bodymenthol and zinc oxideMenthol 1.5 mg/g; Zinc oxide 10 mg/gPowderTopicalWalgreen Co0363-0552
Rugby Muscle Rub Creammuscle rub creamMenthol, Unspecified form 100 mg/g; Methyl salicylate 150 mg/gCreamTopicalPreferred Pharmaceuticals Inc.68788-8729
Avedana Cool Hot IcementholMenthol 2 g/100gGelTopicalUnipack, Inc.43749-321
Walgreens Camphor Phenol Gelcamphor, phenolCamphor (Synthetic) 10.8 mg/g; Phenol 4.7 mg/gGelTopicalWalgreens0363-9425
Discount Drug Mart Anti-itchhydrocortisoneHydrocortisone 1 g/100gCreamTopicalDISCOUNT DRUG MART, INC.53943-269
CVS Sore Muscle Rub Vanishing ScentmentholMenthol .025 g/gCreamTopicalCVS Pharmacy69842-712
Fsk-5lidocaine hydrochloride—KitWater-Jel Technologies59898-170
Pure-Aidlidocaine, mentholLidocaine 240 mg/1; Menthol, Unspecified form 60 mg/1PatchTopicalKareway Product, Inc.67510-0284
Ebsl-5lidocaine hydrochloride—KitWater-Jel Technologies59898-140
Ebss-5lidocaine hydrochloride—KitWater-Jel Technologies59898-160
Soundbodylidocaine, mentholLidocaine 40 mg/1; Menthol 10 mg/1PatchTopicalKareway Product, Inc.67510-0636
Iwk-5lidocaine hydrochloride—KitWater-Jel Technologies59898-180

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