NDC codes

FDA NDC Directory
Product NDC (as listed)11527-069Labeler and product segments. Claims need a package NDC.
Product NDC at billing width11527-0069Add 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
11527-069-0411527006904115270069041 TUBE in 1 CARTON (11527-069-04) / 35 g in 1 TUBEMarketed from Nov 11, 2008

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)
Dr. Sheffield Anti Itch Cream
Generic name (nonproprietary)
anti itch cream
Active ingredients
Diphenhydramine hydrochloride — 20 mg/gZinc acetate — 1 mg/g
Dosage form
Cream
Route
Topical
Labeler
Sheffield Pharmaceuticals LLCNDC labeler code 11527
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 016
Marketing start
Listing expires
Other FDA classes
Decreased Copper Ion Absorption (Physiologic effect)Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 11527-069_36f56c5a-15fe-4243-83a4-e9a54eca9a13SPL ID 36f56c5a-15fe-4243-83a4-e9a54eca9a13SPL set ID 77f0593e-f694-4c02-9fd9-ad56ff2a920cRxCUI 1087026UNII 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

N411527006904 followed by a unit qualifier and the quantity

Package 11527-0069-04. 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 temporary relief from pain and itching associated with : insect bites minor burns sunburn minor skin irritations rashes due to poison ivy, poison oak, and poison sumac Dries the oozing and weeping of poison ivy oak sumac

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 11527-069

What is NDC 11527-069?
11527-069 is the product NDC for Dr. Sheffield Anti Itch Cream (anti itch cream), Diphenhydramine hydrochloride 20 mg/g; Zinc acetate 1 mg/g cream, listed with the FDA by Sheffield Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Dr. Sheffield Anti Itch Cream (Anti Itch Cream).
What is the active ingredient?
Diphenhydramine hydrochloride, Zinc acetate.
Who is the labeler?
Sheffield Pharmaceuticals LLC, NDC labeler code 11527. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dr. Sheffield Anti Itch Cream?
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 016

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under M 016
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Welmedix HomeCare PRO Fragile Skin ProtectantpetrolatumPetrolatum 42 g/100gOintmentTopicalWelmedix LLC24330-413
Petroleumwhite petrolatumPetrolatum 1 g/gJellyTopicalH E B37808-015
Pure Petrolatum JellypetrolatumPetrolatum 100 g/100gJellyTopicalMY IMPORTS USA LLC51628-4600
A and DpetrolatumPetrolatum 76 g/100gOintmentTopicalSafetec of America, Inc.61010-4405
Dermatitis Face Balmcolloidal oatmealOatmeal 5 g/100gOintmentTopicalSkinfix, Inc.61328-121
McKesson Skin Protectantzinc oxideZinc oxide 50 mg/mLCreamTopicalMcKesson Medical-Surgical Inc.68599-5312
All Over Lavender Rosemarycolloidal oat ointmentOatmeal 1 g/100gOintmentTopicalTubby Todd73088-303
XIMONTH GLP-1 PatchesglycerinAcetyl hexapeptide-8 amide .006 mg/30mg; Rose oil .006 mg/30mgPatchTopicalShantou Ximonth Biotechnology Co., Ltd.84989-009
Deep Renewal Broad Spectrumdimethicone, avobenzone, homosalate, and octisalateDimethicone 2 g/100g + 3 more ingredientsStickTopicalBlistex Inc10157-1170
Skin Soothing Cream - Nut Freecolloidal oatmealOatmeal 1 mg/gCreamTopicalAllure Labs62742-4194
Lavender Scent Petroleumwhite petroleumPetrolatum 99.9 g/100gJellyTopicalJell Pharmaceuticals Pvt Ltd30400-514
Witch HazelWitch hazel 842 mg/mLLiquidTopicalEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)49035-039
Eczema Dermatitis Relief Balmcolloidal oatmealOatmeal 5 g/100gCreamTopicalSkinfix, Inc.61328-112
Dovenourishing hand sanitizer sensitive skin 8hr moisturizationAlcohol 610 mg/mLGelTopicalConopco Inc. d/b/a/ Unilever64942-1996
Petroleum Skin Protectantwhite petrolatumPetrolatum 1 g/gJellyTopicalPharmacy Value Alliance, LLC68016-069
Sweet Cheeks Diaper Sprayerzinc oxide diaper paste sprayZinc oxide 14.9 g/100gSprayTopicalTubby Todd73088-304
Estrogen Estriol Cream5% estriolEstriol 5 g/100gCreamTopicalYITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD83364-026
Earthmed FS massage oilallantoinAllantoin 1 g/108.48gOilTopicalEarthmed LLC82876-986

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