bunnies bum soothing hemorrhoidal

Generic: glycerin, lidocaine, petrolatum, phenylephrine hcl

Labeler: flocal distributors llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name bunnies bum soothing hemorrhoidal
Generic Name glycerin, lidocaine, petrolatum, phenylephrine hcl
Labeler flocal distributors llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

glycerin 14.4 g/100g, lidocaine 5 g/100g, petrolatum 15 g/100g, phenylephrine hydrochloride .25 g/100g

Manufacturer
FloCal Distributors LLC

Identifiers & Regulatory

Product NDC 84308-161
Product ID 84308-161_1c81582c-7ecf-182f-e063-6294a90a8fbc
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M015
Listing Expiration 2026-12-31
Marketing Start 2024-07-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 84308161
Hyphenated Format 84308-161

Supplemental Identifiers

RxCUI
2642220
UNII
PDC6A3C0OX 98PI200987 4T6H12BN9U 04JA59TNSJ
NUI
N0000185370 N0000175629 N0000184306 N0000185001 M0000728 M0009417 N0000175682 M0000897 N0000175426 N0000175976

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 bunnies bum soothing hemorrhoidal (source: ndc)
Generic Name glycerin, lidocaine, petrolatum, phenylephrine hcl (source: ndc)
Application Number M015 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 14.4 g/100g
  • 5 g/100g
  • 15 g/100g
  • .25 g/100g
source: ndc
Packaging
  • 57 g in 1 TUBE (84308-161-02)
source: ndc

Packages (1)

84308-161-02 57 g in 1 TUBE (84308-161-02)

Ingredients (4)

glycerin (14.4 g/100g) lidocaine (5 g/100g) petrolatum (15 g/100g) phenylephrine hydrochloride (.25 g/100g)

Linked Drug Pages (1)

Bunnies Bum Soothing Hemorrhoidal ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "1c81582c-7ecf-182f-e063-6294a90a8fbc", "openfda": {"nui": ["N0000185370", "N0000175629", "N0000184306", "N0000185001", "M0000728", "M0009417", "N0000175682", "M0000897", "N0000175426", "N0000175976"], "unii": ["PDC6A3C0OX", "98PI200987", "4T6H12BN9U", "04JA59TNSJ"], "rxcui": ["2642220"], "spl_set_id": ["1c81582c-7ece-182f-e063-6294a90a8fbc"], "pharm_class_cs": ["Allergens [CS]", "Glycerol [CS]", "Amides [CS]"], "pharm_class_pe": ["Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]", "Increased IgG Production [PE]", "Local Anesthesia [PE]"], "pharm_class_epc": ["Non-Standardized Chemical Allergen [EPC]", "Amide Local Anesthetic [EPC]", "Antiarrhythmic [EPC]"], "manufacturer_name": ["FloCal Distributors LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "57 g in 1 TUBE (84308-161-02)", "package_ndc": "84308-161-02", "marketing_start_date": "20240708"}], "brand_name": "Bunnies Bum Soothing Hemorrhoidal", "product_id": "84308-161_1c81582c-7ecf-182f-e063-6294a90a8fbc", "dosage_form": "CREAM", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Allergens [CS]", "Amide Local Anesthetic [EPC]", "Amides [CS]", "Antiarrhythmic [EPC]", "Cell-mediated Immunity [PE]", "Glycerol [CS]", "Increased Histamine Release [PE]", "Increased IgG Production [PE]", "Local Anesthesia [PE]", "Non-Standardized Chemical Allergen [EPC]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "84308-161", "generic_name": "Glycerin, Lidocaine, Petrolatum, Phenylephrine HCl", "labeler_name": "FloCal Distributors LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Bunnies Bum Soothing Hemorrhoidal", "active_ingredients": [{"name": "GLYCERIN", "strength": "14.4 g/100g"}, {"name": "LIDOCAINE", "strength": "5 g/100g"}, {"name": "PETROLATUM", "strength": "15 g/100g"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": ".25 g/100g"}], "application_number": "M015", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240708", "listing_expiration_date": "20261231"}