NDC codes

FDA NDC Directory
Product NDC (as listed)43347-158Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43347-0158Add 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
43347-158-01433470158011 TUBE, WITH APPLICATOR in 1 BOX (43347-158-01) / 28 g in 1 TUBE, WITH APPLICATORMarketed from Aug 15, 2016

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)
Thera Wise Natural Hemorrhoidal
Generic name (nonproprietary)
witch hazel
Active ingredients
Witch hazel — 3.36 g/28g
Dosage form
Ointment
Route
Rectal, Topical
Labeler
Derma Wise Skin Care Ltd.NDC labeler code 43347
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 016
Marketing start
Listing expires
Identifiers
Product ID 43347-158_b0575217-f40b-44cc-a38d-9bb99fa49d00SPL ID b0575217-f40b-44cc-a38d-9bb99fa49d00SPL set ID a29fb680-cfc8-4a7b-9970-563fa0e2bed6RxCUI 1804849UNII 101I4J0U34

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N443347015801 followed by a unit qualifier and the quantity

Package 43347-0158-01. 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 For the temporary relief of anorectal discomfort associated with hemorrhoids For the temporary relief of local itching associated with hemorrhoids

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43347-158

What is NDC 43347-158?
43347-158 is the product NDC for Thera Wise Natural Hemorrhoidal (witch hazel), Witch hazel 3.36 g/28g ointment, listed with the FDA by Derma Wise Skin Care Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Thera Wise Natural Hemorrhoidal (Witch Hazel).
What is the active ingredient?
Witch hazel.
Who is the labeler?
Derma Wise Skin Care Ltd., NDC labeler code 43347. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Thera Wise Natural Hemorrhoidal?
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
ProductStrengthForm · routeLabelerProduct NDC
Colloidal oatmealOatmeal 10 mg/gCreamTopicalMeijer, Inc.79481-6601
Gold Bond Eczema Relief Medicated Hand Creamcolloidal oatmealOatmeal 2 g/100gCreamTopicalChattem, Inc.41167-0668
Venrockrosemary oilRosmarinus officinalis (Rosemary) leaf oil 55 g/100g; Biotin .001 g/100gOilTopicalGuangzhou Oupeng Cosmetics Co., Ltd85772-0007
First Aid Beauty FAB Ultra Repair Body Skin Protectantcolloidal oatmealOatmeal .5 g/100gLotionTopicalThe Procter & Gamble Manufacturing Company69423-726
AHHH Bite Reliefsodium bicarbonateSodium bicarbonate 5 g/25gGelTopical7827178271-041
Vitacilina Bebe Diaper Rashzinc oxideZinc oxide 400 mg/gOintmentTopicalTaisho Pharmaceutical California Inc.81929-002
Witch HazelWitch hazel 842 mg/mLLiquidTopicalTOP CARE (Topco Associates LLC)36800-039
First Aid Beauty Face and Body Bestsellers Kitcolloidal oatmeal—KitTopicalThe Procter & Gamble Manufacturing Company84126-911
Skin Protectant with 33% Petrolatum Advance Moisturizing CreampetrolatumPetrolatum 33 g/100gCreamTopicalAldermed Inc.87236-011
Theriac Advanced HealinglanolinLanolin 350.8 mg/gOintmentTopicalSheffield Pharmaceuticals LLC11527-325
XtraCare Creamy Petroleum JellypetrolatumPetrolatum 38 g/127gJellyTopicalRejoice International57337-060
Sarnacolloidal oatmealOatmeal 20 mg/mLLotionTopicalCrown Laboratories, Inc.0316-0256
Zinc Oxide 20%zinc oxideZinc oxide .2 g/gOintmentTopicalTrifecta Pharmaceuticals USA69396-021
FIRST AID BEAUTY FAB ULTRA REPAIR SKIN PROTECTANT Kitcolloidal oatmeal—KitTopicalThe Procter & Gamble Manufacturing Company84126-912
ProCure Zinc Oxidezinc oxideZinc oxide 20 g/100gOintmentTopicalTwin Med LLC55681-017
XtraCare Creamy Petroleum JellypetrolatumPetrolatum 38 g/127gJellyTopicalRejoice International57337-061
Zinc Oxide 20%zinc oxideZinc oxide .2 g/gOintmentTopicalTrifecta Pharmaceuticals USA69396-021
Desitin Maximum Strength Zinc Oxide Diaper Rashzinc oxideZinc oxide 400 mg/gPasteTopicalKenvue Brands LLC69968-0396
HydrophorPetrolatum 42 g/100gOintmentTopicalAkron Pharma Inc.71399-5101
Attitude Diaper Cream Zinc Unscentedzinc oxideZinc oxide 15 g/100gStickTopical9055-7588 Quebec Inc. (Attitude)61649-260

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