NDC codes

FDA NDC Directory
Product NDC (as listed)58503-011Labeler and product segments. Claims need a package NDC.
Product NDC at billing width58503-0011Add 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
58503-011-015850300110158503001101500 mg in 1 BOTTLE (58503-011-01)Marketed from May 24, 2013

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)
triclosan
Active ingredients
Triclosan — 7.5 mg/500mg
Dosage form
Gel
Route
Topical
Product type
Over-the-counter drug
Marketing category
OTC monograph (not final)Application part333E
Marketing start
Listing expires
Identifiers
Product ID 58503-011_93f48a33-47da-88bd-e053-2a95a90ae37aSPL ID 93f48a33-47da-88bd-e053-2a95a90ae37aSPL set ID 42ba673c-cf0d-4a96-8eb4-0ad4f33bc018UNII 4NM5039Y5XUPC 0639277315816

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

N458503001101 followed by a unit qualifier and the quantity

Package 58503-0011-01. 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)

Other information store at 20oC to 25oC (68o to 77oF)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 58503-011

What is NDC 58503-011?
58503-011 is the product NDC for Hand Cleanse - Strawberry Pomegranate, Triclosan 7.5 mg/500mg gel, listed with the FDA by China Ningbo Shangge Cosmetic Technology Corp.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Hand Cleanse - Strawberry Pomegranate (Triclosan).
What is the active ingredient?
Triclosan.
Who is the labeler?
China Ningbo Shangge Cosmetic Technology Corp., NDC labeler code 58503. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Hand Cleanse - Strawberry Pomegranate?
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 part333E

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

FDA NDC Directory listings under part333E
ProductStrengthForm · routeLabelerProduct NDC
Afassco Hand SanitizeralcoholAlcohol 62 mL/100mLLiquidTopicalJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.71734-206
Alcohol WipesalcoholAlcohol .31 mL/mLClothTopicalJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.71734-202
Antimicrobial Face Body Washbenzethonium chloride liquidBenzethonium chloride .2 g/100gLiquidTopicalBio-Medical & Pharmaceutical Manufacturing Corporation37945-902
DEFENSE Hand Sanitizerisopropyl alcoholIsopropyl alcohol .75 mL/mLLiquidTopicalWalla Walla Environmental, Inc.80579-000
DEFENSE Hand Sanitizerisopropyl alcoholIsopropyl alcohol .75 mL/mLLiquidTopicalWalla Walla Environmental, Inc.80579-001
Discount Drug Mart Vitamin E Hand Sanitizerethyl alcoholAlcohol 650 mg/mLLiquidTopicalDiscount Drug Mart53943-022
Freeman Packaging Hand SanitizeralcoholAlcohol 62 mL/100mLLiquidTopicalJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.71734-201
Hand SanitizerAlcohol .62 mL/mLGelTopicalLS Promotions Inc.72449-100
Harris Teeter Spring Fresh Body Washbenzalkonium chlorideBenzalkonium chloride 1.3 mg/mLLiquidTopicalHarris Teeter72036-801
Instant Hand SanitizeralcoholAlcohol 665 mg/LGelTopicalSafetec of America, Inc.61010-5111
Isopropyl AlcoholalcoholAlcohol 70 mL/100mLSprayTopicalZee Medical35418-402
KidzStuff Hand SanitizeralcoholAlcohol 62 g/100gLiquidTopicalJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.71734-204
ONID WipeethanolAlcohol 75 mL/100mLSwabTopicalONID Technology Corp71441-180

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