signature care hemorrhoidal cream (with applicator)

Generic: phenylephrine hydrochloride, pramoxine hydrochloride, glycerin, petrolatum

Labeler: better living brands, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name signature care hemorrhoidal cream (with applicator)
Generic Name phenylephrine hydrochloride, pramoxine hydrochloride, glycerin, petrolatum
Labeler better living brands, llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

glycerin 144 mg/g, petrolatum 150 mg/g, phenylephrine hydrochloride 2.5 mg/g, pramoxine hydrochloride 10 mg/g

Manufacturer
BETTER LIVING BRANDS, LLC

Identifiers & Regulatory

Product NDC 21130-981
Product ID 21130-981_41ecac83-195d-7b49-e063-6394a90a1b27
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M015
Listing Expiration 2026-12-31
Marketing Start 2021-01-04

Pharmacologic Class

Established (EPC)
non-standardized chemical allergen [epc]
Chemical Structure
allergens [cs] glycerol [cs]
Physiologic Effect
increased histamine release [pe] cell-mediated immunity [pe] increased igg production [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 21130981
Hyphenated Format 21130-981

Supplemental Identifiers

RxCUI
1293649
UPC
0321130789819
UNII
PDC6A3C0OX 4T6H12BN9U 04JA59TNSJ 88AYB867L5
NUI
N0000185370 N0000175629 N0000184306 N0000185001 M0000728 M0009417

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name signature care hemorrhoidal cream (with applicator) (source: ndc)
Generic Name phenylephrine hydrochloride, pramoxine hydrochloride, glycerin, petrolatum (source: ndc)
Application Number M015 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 144 mg/g
  • 150 mg/g
  • 2.5 mg/g
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE, WITH APPLICATOR in 1 CARTON (21130-981-02) / 57 g in 1 TUBE, WITH APPLICATOR
source: ndc

Packages (1)

21130-981-02 1 TUBE, WITH APPLICATOR in 1 CARTON (21130-981-02) / 57 g in 1 TUBE, WITH APPLICATOR

Ingredients (4)

glycerin (144 mg/g) petrolatum (150 mg/g) phenylephrine hydrochloride (2.5 mg/g) pramoxine hydrochloride (10 mg/g)

Linked Drug Pages (1)

Signature Care Hemorrhoidal Cream (with applicator) ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "41ecac83-195d-7b49-e063-6394a90a1b27", "openfda": {"nui": ["N0000185370", "N0000175629", "N0000184306", "N0000185001", "M0000728", "M0009417"], "upc": ["0321130789819"], "unii": ["PDC6A3C0OX", "4T6H12BN9U", "04JA59TNSJ", "88AYB867L5"], "rxcui": ["1293649"], "spl_set_id": ["b026a386-5e38-52ed-e053-2a95a90a6b0e"], "pharm_class_cs": ["Allergens [CS]", "Glycerol [CS]"], "pharm_class_pe": ["Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]", "Increased IgG Production [PE]"], "pharm_class_epc": ["Non-Standardized Chemical Allergen [EPC]"], "manufacturer_name": ["BETTER LIVING BRANDS, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE, WITH APPLICATOR in 1 CARTON (21130-981-02)  / 57 g in 1 TUBE, WITH APPLICATOR", "package_ndc": "21130-981-02", "marketing_start_date": "20210104"}], "brand_name": "Signature Care Hemorrhoidal Cream (with applicator)", "product_id": "21130-981_41ecac83-195d-7b49-e063-6394a90a1b27", "dosage_form": "CREAM", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Allergens [CS]", "Cell-mediated Immunity [PE]", "Glycerol [CS]", "Increased Histamine Release [PE]", "Increased IgG Production [PE]", "Non-Standardized Chemical Allergen [EPC]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "21130-981", "generic_name": "Phenylephrine Hydrochloride, Pramoxine Hydrochloride, Glycerin, Petrolatum", "labeler_name": "BETTER LIVING BRANDS, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Signature Care Hemorrhoidal Cream (with applicator)", "active_ingredients": [{"name": "GLYCERIN", "strength": "144 mg/g"}, {"name": "PETROLATUM", "strength": "150 mg/g"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "2.5 mg/g"}, {"name": "PRAMOXINE HYDROCHLORIDE", "strength": "10 mg/g"}], "application_number": "M015", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20210104", "listing_expiration_date": "20261231"}