NDC codes

FDA NDC Directory
Product NDC (as listed)21130-981Labeler and product segments. Claims need a package NDC.
Product NDC at billing width21130-0981Add 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
21130-981-0221130098102211300981021 TUBE, WITH APPLICATOR in 1 CARTON (21130-981-02) / 57 g in 1 TUBE, WITH APPLICATORMarketed from Jan 4, 2021

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)
phenylephrine hydrochloride, pramoxine hydrochloride, glycerin, petrolatum
Active ingredients
Phenylephrine hydrochloride — 2.5 mg/gPramoxine hydrochloride — 10 mg/gGlycerin — 144 mg/gPetrolatum — 150 mg/g
Dosage form
Cream
Route
Topical
Labeler
BETTER LIVING BRANDS, LLCNDC labeler code 21130
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 015
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha1-Agonists (Mechanism)Allergens (Chemical structure)Cell-mediated Immunity (Physiologic effect)Glycerol (Chemical structure)Increased Histamine Release (Physiologic effect)Increased IgG Production (Physiologic effect)
Identifiers
Product ID 21130-981_41ecac83-195d-7b49-e063-6394a90a1b27SPL ID 41ecac83-195d-7b49-e063-6394a90a1b27SPL set ID b026a386-5e38-52ed-e053-2a95a90a6b0eRxCUI 1293649UNII 04JA59TNSJ, 88AYB867L5, PDC6A3C0OX, 4T6H12BN9UUPC 0321130789819
Pharmacologic class
Non-Standardized Chemical Allergen; alpha-1 Adrenergic Agonist

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

N421130098102 followed by a unit qualifier and the quantity

Package 21130-0981-02. 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)

Directions adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying cream. when first opening the tube, peel back foil seal apply externally or in the lower portion of the anal canal only apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement for application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube. Lubricate dispensing cap well, then gently insert dispensing cap partway into the anus thoroughly cleanse dispensing cap after each use and replace co…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 21130-981

What is NDC 21130-981?
21130-981 is the product NDC for Signature Care Hemorrhoidal Cream (with applicator), Phenylephrine hydrochloride 2.5 mg/g + 3 more ingredients cream, listed with the FDA by BETTER LIVING BRANDS, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Signature Care Hemorrhoidal Cream (with applicator) (Phenylephrine Hydrochloride, Pramoxine Hydrochloride, Glycerin, Petrolatum).
What is the active ingredient?
Phenylephrine hydrochloride, Pramoxine hydrochloride, Glycerin, Petrolatum.
Who is the labeler?
BETTER LIVING BRANDS, LLC, NDC labeler code 21130. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Signature Care Hemorrhoidal Cream (with applicator)?
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
Dr. NumblidocaineLidocaine 5 g/100mLCreamTopicalShinpharma Inc69903-006
Hemorrhoidalmineral oil, petrolatum, phenylephrine hclMineral oil 14 g/100g + 2 more ingredientsOintmentRectalBryant Ranch Prepack72162-2282
Numbskin Maximum Strength Pain RelieverlidocaineLidocaine 5 g/100mLCreamTopicalShinpharma Inc69903-008
equate hemorrhoidalglycerin, phenylephrine hcl, pramoxine hcl, white petrolatumGlycerin 14.4 g/100g + 3 more ingredientsCreamTopicalWal-Mart Stores Inc49035-944
Medpride Relieflidocaine 5%Lidocaine 50 mg/gCreamTopicalShield Line LLC52410-1090
RectaEase Hemorrhoid Relief CreamlidocaineLidocaine 50 mg/gCreamTopicalTrifecta Pharmaceuticals USA LLC69396-070
Drmitsui Medical Haemorrhoidphenylephrine hci witch hazelWitch hazel 50 g/100g; Phenylephrine hydrochloride .25 g/100gGelTopicalYIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED87267-011
ProCure Hemorrhoidalmineral oil, petrolatum, phenylephrine hclPetrolatum 74.9 g/100g + 2 more ingredientsOintmentRectal, TopicalTwin Med LLC55681-021
Lidocaine Numbing CreamlidocaineLidocaine .05 g/gCreamTopicalGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.83602-311
Hemorrhoidalmineral oil, petrolatum, phenylephrine hclMineral oil 14 g/100g + 2 more ingredientsOintmentRectalShield Line LLC52410-1820
Rectal Care CreamLidocaine 5 g/100gCreamRectal, TopicalAllegiant Health69168-484
HemorrhoidalOintmentmineral oil, petrolatum, phenylephrine hciMineral oil 14 g/100g + 2 more ingredientsOintmentTopicalTrifecta Pharmaceuticals USA LLC69396-082
HemorrhoidalOintmentmineral oil, petrolatum, phenylephrine hciPetrolatum 74.9 g/100g + 2 more ingredientsOintmentTopicalTrifecta Pharmaceuticals USA LLC69396-083
CAREALL Hemorrhoidalmineral oil, petrolatum, phenylephrine hclMineral oil 140 mg/g + 2 more ingredientsOintmentTopicalNew World Imports, Inc51824-079
Preparation H For Womenwitch hazelWitch hazel 2 g/1ClothTopicalHaleon US Holdings LLC0573-0559
Equaline Hemorrhoidalglycerin, phenylephrine hcl, pramoxine hcl, white petrolatumGlycerin 14.4 g/100g + 3 more ingredientsCreamTopicalUnited Natural Foods, Inc. dba UNFI41163-944
TheraCare Hemorrhoidalmineral oil, petrolatum, phenylephrine hclMineral oil 14 g/100g + 2 more ingredientsOintmentRectalVeridian Healthcare71101-935
Bunnies Bum Soothing Hemorrhoidalglycerin, lidocaine, petrolatum, phenylephrine hclGlycerin 14.4 g/100g + 3 more ingredientsCreamTopicalFloCal Distributors LLC84308-161
0.25 % PHENYLEPHRINE HCl HEMORRHOIDALmineral oil, petrolatum, phenylephrine hydrochlorideMineral oil 14 g/100g + 2 more ingredientsOintmentTopicalUniversal Distribution Center LLC52000-438
Lidocaine Patchlidocaine 4%Lidocaine 4 g/100gPatchTopicalSLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS73317-6866

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