Over-the-counter drug · OTC MONOGRAPH DRUG
Signature Care Hemorrhoidal Cream (with applicator) NDC 21130-981
phenylephrine hydrochloride, pramoxine hydrochloride, glycerin, petrolatum · Phenylephrine hydrochloride 2.5 mg/g + 3 more ingredients · Cream · Topical · BETTER LIVING BRANDS, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 21130-981-02 | 2113009810221130098102 | 1 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
- Brand name (proprietary)
- Signature Care Hemorrhoidal Cream (with applicator)
- 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
N421130098102followed by a unit qualifier and the quantityPackage 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.
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.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Dr. Numblidocaine | Lidocaine 5 g/100mL | CreamTopical | Shinpharma Inc | 69903-006 |
| Hemorrhoidalmineral oil, petrolatum, phenylephrine hcl | Mineral oil 14 g/100g + 2 more ingredients | OintmentRectal | Bryant Ranch Prepack | 72162-2282 |
| Numbskin Maximum Strength Pain Relieverlidocaine | Lidocaine 5 g/100mL | CreamTopical | Shinpharma Inc | 69903-008 |
| equate hemorrhoidalglycerin, phenylephrine hcl, pramoxine hcl, white petrolatum | Glycerin 14.4 g/100g + 3 more ingredients | CreamTopical | Wal-Mart Stores Inc | 49035-944 |
| Medpride Relieflidocaine 5% | Lidocaine 50 mg/g | CreamTopical | Shield Line LLC | 52410-1090 |
| RectaEase Hemorrhoid Relief Creamlidocaine | Lidocaine 50 mg/g | CreamTopical | Trifecta Pharmaceuticals USA LLC | 69396-070 |
| Drmitsui Medical Haemorrhoidphenylephrine hci witch hazel | Witch hazel 50 g/100g; Phenylephrine hydrochloride .25 g/100g | GelTopical | YIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED | 87267-011 |
| ProCure Hemorrhoidalmineral oil, petrolatum, phenylephrine hcl | Petrolatum 74.9 g/100g + 2 more ingredients | OintmentRectal, Topical | Twin Med LLC | 55681-021 |
| Lidocaine Numbing Creamlidocaine | Lidocaine .05 g/g | CreamTopical | Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. | 83602-311 |
| Hemorrhoidalmineral oil, petrolatum, phenylephrine hcl | Mineral oil 14 g/100g + 2 more ingredients | OintmentRectal | Shield Line LLC | 52410-1820 |
| Rectal Care Cream | Lidocaine 5 g/100g | CreamRectal, Topical | Allegiant Health | 69168-484 |
| HemorrhoidalOintmentmineral oil, petrolatum, phenylephrine hci | Mineral oil 14 g/100g + 2 more ingredients | OintmentTopical | Trifecta Pharmaceuticals USA LLC | 69396-082 |
| HemorrhoidalOintmentmineral oil, petrolatum, phenylephrine hci | Petrolatum 74.9 g/100g + 2 more ingredients | OintmentTopical | Trifecta Pharmaceuticals USA LLC | 69396-083 |
| CAREALL Hemorrhoidalmineral oil, petrolatum, phenylephrine hcl | Mineral oil 140 mg/g + 2 more ingredients | OintmentTopical | New World Imports, Inc | 51824-079 |
| Preparation H For Womenwitch hazel | Witch hazel 2 g/1 | ClothTopical | Haleon US Holdings LLC | 0573-0559 |
| Equaline Hemorrhoidalglycerin, phenylephrine hcl, pramoxine hcl, white petrolatum | Glycerin 14.4 g/100g + 3 more ingredients | CreamTopical | United Natural Foods, Inc. dba UNFI | 41163-944 |
| TheraCare Hemorrhoidalmineral oil, petrolatum, phenylephrine hcl | Mineral oil 14 g/100g + 2 more ingredients | OintmentRectal | Veridian Healthcare | 71101-935 |
| Bunnies Bum Soothing Hemorrhoidalglycerin, lidocaine, petrolatum, phenylephrine hcl | Glycerin 14.4 g/100g + 3 more ingredients | CreamTopical | FloCal Distributors LLC | 84308-161 |
| 0.25 % PHENYLEPHRINE HCl HEMORRHOIDALmineral oil, petrolatum, phenylephrine hydrochloride | Mineral oil 14 g/100g + 2 more ingredients | OintmentTopical | Universal Distribution Center LLC | 52000-438 |
| Lidocaine Patchlidocaine 4% | Lidocaine 4 g/100g | PatchTopical | SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS | 73317-6866 |
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