abreva rapid pain relief

Generic: glycerin, lidocaine

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

Drug Facts

Product Profile

Brand Name abreva rapid pain relief
Generic Name glycerin, lidocaine
Labeler haleon us holdings llc
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

glycerin 200 mg/g, lidocaine hydrochloride 40 mg/g

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0135-0400
Product ID 0135-0400_1b52dd69-d74d-3137-e063-6394a90ab541
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2023-06-01

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 01350400
Hyphenated Format 0135-0400

Supplemental Identifiers

RxCUI
2637870 2637875
UNII
PDC6A3C0OX V13007Z41A
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 abreva rapid pain relief (source: ndc)
Generic Name glycerin, lidocaine (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/g
  • 40 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 PACKAGE (0135-0400-01) / 3 g in 1 TUBE
source: ndc

Packages (1)

0135-0400-01 1 TUBE in 1 PACKAGE (0135-0400-01) / 3 g in 1 TUBE

Ingredients (2)

glycerin (200 mg/g) lidocaine hydrochloride (40 mg/g)

Linked Drug Pages (1)

ABREVA Rapid Pain Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "1b52dd69-d74d-3137-e063-6394a90ab541", "openfda": {"nui": ["N0000185370", "N0000175629", "N0000184306", "N0000185001", "M0000728", "M0009417"], "unii": ["PDC6A3C0OX", "V13007Z41A"], "rxcui": ["2637870", "2637875"], "spl_set_id": ["65bd242f-4c6a-436c-8ec0-7b2e0d73ed9d"], "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": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 PACKAGE (0135-0400-01)  / 3 g in 1 TUBE", "package_ndc": "0135-0400-01", "marketing_start_date": "20230601"}], "brand_name": "ABREVA Rapid Pain Relief", "product_id": "0135-0400_1b52dd69-d74d-3137-e063-6394a90ab541", "dosage_form": "GEL", "pharm_class": ["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]"], "product_ndc": "0135-0400", "generic_name": "glycerin, lidocaine", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ABREVA", "brand_name_suffix": "Rapid Pain Relief", "active_ingredients": [{"name": "GLYCERIN", "strength": "200 mg/g"}, {"name": "LIDOCAINE HYDROCHLORIDE", "strength": "40 mg/g"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230601", "listing_expiration_date": "20261231"}