preparation h rapid relief

Generic: glycerin, lidocaine, phenylephrine hydrochloride

Labeler: haleon us holdings llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name preparation h rapid relief
Generic Name glycerin, lidocaine, phenylephrine hydrochloride
Labeler haleon us holdings llc
Dosage Form CLOTH
Routes
TOPICAL
Active Ingredients

glycerin 200 mg/1, lidocaine 50 mg/1, phenylephrine hydrochloride 2.5 mg/1

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0573-0554
Product ID 0573-0554_47e795a4-2ed4-9966-e063-6394a90a4955
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M015
Listing Expiration 2027-12-31
Marketing Start 2019-03-01

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 05730554
Hyphenated Format 0573-0554

Supplemental Identifiers

RxCUI
1745438
UNII
PDC6A3C0OX 98PI200987 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 preparation h rapid relief (source: ndc)
Generic Name glycerin, lidocaine, phenylephrine hydrochloride (source: ndc)
Application Number M015 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
  • 50 mg/1
  • 2.5 mg/1
source: ndc
Packaging
  • 20 POUCH in 1 CARTON (0573-0554-20) / 1 CLOTH in 1 POUCH
source: ndc

Packages (1)

0573-0554-20 20 POUCH in 1 CARTON (0573-0554-20) / 1 CLOTH in 1 POUCH

Ingredients (3)

glycerin (200 mg/1) lidocaine (50 mg/1) phenylephrine hydrochloride (2.5 mg/1)

Linked Drug Pages (1)

Preparation H Rapid Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "47e795a4-2ed4-9966-e063-6394a90a4955", "openfda": {"nui": ["N0000185370", "N0000175629", "N0000184306", "N0000185001", "M0000728", "M0009417", "N0000175682", "M0000897", "N0000175426", "N0000175976"], "unii": ["PDC6A3C0OX", "98PI200987", "04JA59TNSJ"], "rxcui": ["1745438"], "spl_set_id": ["49a93cfc-4ccd-4ef3-928f-901b9926f794"], "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": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 POUCH in 1 CARTON (0573-0554-20)  / 1 CLOTH in 1 POUCH", "package_ndc": "0573-0554-20", "marketing_start_date": "20190301"}], "brand_name": "Preparation H Rapid Relief", "product_id": "0573-0554_47e795a4-2ed4-9966-e063-6394a90a4955", "dosage_form": "CLOTH", "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": "0573-0554", "generic_name": "Glycerin, Lidocaine, Phenylephrine Hydrochloride", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Preparation H Rapid Relief", "active_ingredients": [{"name": "GLYCERIN", "strength": "200 mg/1"}, {"name": "LIDOCAINE", "strength": "50 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "2.5 mg/1"}], "application_number": "M015", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20190301", "listing_expiration_date": "20271231"}