family wellness (69571-004)

Drug Facts

Product Profile

Brand Name family wellness

Generic Name glycerin, phenylephrine hcl, pramoxine hcl, petrolatum

Labeler front pharmaceutical plc

Dosage Form CREAM

Routes

TOPICAL

Active Ingredients

glycerin 14.4 g/100g, petrolatum 15 g/100g, phenylephrine hydrochloride .25 g/100g, pramoxine hydrochloride 1 g/100g

Manufacturer

FRONT PHARMACEUTICAL PLC

Identifiers & Regulatory

Product NDC 69571-004

Product ID 69571-004_08a17869-d45f-18ce-e063-6394a90adbbb

Product Type HUMAN OTC DRUG

Marketing Category OTC MONOGRAPH DRUG

Application Number M015

Listing Expiration 2026-12-31

Marketing Start 2017-03-14

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 69571004

Hyphenated Format 69571-004

Supplemental Identifiers

RxCUI

1293649

UPC

0032251238215

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 family wellness (source: ndc)

Generic Name glycerin, phenylephrine hcl, pramoxine hcl, petrolatum (source: ndc)

Application Number M015 (source: ndc)

Routes

TOPICAL

source: ndc

Resolved Composition

Strengths

14.4 g/100g
15 g/100g
.25 g/100g
1 g/100g

source: ndc

Packaging

1 TUBE in 1 BOX (69571-004-02) / 26 g in 1 TUBE (69571-004-01)

source: ndc

Packages (1)

69571-004-02 1 TUBE in 1 BOX (69571-004-02) / 26 g in 1 TUBE (69571-004-01)

Ingredients (4)

glycerin (14.4 g/100g) petrolatum (15 g/100g) phenylephrine hydrochloride (.25 g/100g) pramoxine hydrochloride (1 g/100g)

Linked Drug Pages (1)

Family Wellness ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["TOPICAL"], "spl_id": "08a17869-d45f-18ce-e063-6394a90adbbb", "openfda": {"nui": ["N0000185370", "N0000175629", "N0000184306", "N0000185001", "M0000728", "M0009417"], "upc": ["0032251238215"], "unii": ["PDC6A3C0OX", "4T6H12BN9U", "04JA59TNSJ", "88AYB867L5"], "rxcui": ["1293649"], "spl_set_id": ["eb1785f4-5876-443b-b175-9b59d65d1a48"], "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": ["FRONT PHARMACEUTICAL PLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 BOX (69571-004-02)  / 26 g in 1 TUBE (69571-004-01)", "package_ndc": "69571-004-02", "marketing_start_date": "20170314"}], "brand_name": "Family Wellness", "product_id": "69571-004_08a17869-d45f-18ce-e063-6394a90adbbb", "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": "69571-004", "generic_name": "GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, PETROLATUM", "labeler_name": "FRONT PHARMACEUTICAL PLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Family Wellness", "active_ingredients": [{"name": "GLYCERIN", "strength": "14.4 g/100g"}, {"name": "PETROLATUM", "strength": "15 g/100g"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": ".25 g/100g"}, {"name": "PRAMOXINE HYDROCHLORIDE", "strength": "1 g/100g"}], "application_number": "M015", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20170314", "listing_expiration_date": "20261231"}