FDA.reportPublic FDA data

ABREVA

Manufacturer
Haleon US Holdings LLC
Effective date
2024-06-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:13:54

Label at a glance#

ProductABREVA Rapid Pain Relief
Active ingredientGLYCERIN, LIDOCAINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

for the temporary relief of pain and itching associated with cold sores and fever blisters Relieves dryness and softens cold sores and fever blisters Softens crust (scabs) associated with cold sores and fever blisters

Dosage and administration

push and turn cap to open, close tightly after use wash hands before and after applying adults and children 12 years of age and older : apply to affected area not more than 3 to 4 times daily children under 12 years : consult a doctor

Storage and handling

store at 20-25 o C (68 o -77 o F)

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Glycerin 20%

Lidocaine HCl 4%

Purposes

OTC - PURPOSE SECTION

Lip Protectant

External Analgesic

Uses

INDICATIONS & USAGE SECTION

  • for the temporary relief of pain and itching associated with cold sores and fever blisters
  • Relieves dryness and softens cold sores and fever blisters
  • Softens crust (scabs) associated with cold sores and fever blisters

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • in large quantities, particularly over raw surfaces, or blistered areas

When using this product

OTC - WHEN USING SECTION

  1. do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • push and turn cap to open, close tightly after use
  • wash hands before and after applying
  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years: consult a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25 oC (68 o-77 oF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

edetate disodium, hydroxyethyl cellulose, menthol, methylparaben, polysorbate 80, propylene glycol,

propylparaben, trisodium citrate dihydrate, water

Questions or comments?

OTC - QUESTIONS SECTION

1-877-709-3539

Additional Information

SPL UNCLASSIFIED SECTION

Retain outer carton for full product uses, directions and warnings.

Do not use if carton is broken or damaged.

CARTON Recycle

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

abreva

RAPID

PAIN RELIEF

Cold Sore

MAX

STRENGTH

LIDOCAINE

For rapid numbing effect

Lidocaine HCl 4% / Glycerin 20%

External Analgesic / Lip Protectant

NET WT 3 g (0.10 oz)

PA 202119 – Front Panel

PA 202119 Abreva Rapid Pain Relief 3g
PA 202119 Abreva Rapid Pain Relief 3g

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2637875Abreva Rapid Pain Relief 20 % / 4 % Topical GelPSN3
2637870glycerin 20 % / lidocaine hydrochloride 4 % Topical GelPSN3
2637875glycerin 0.2 MG/MG / lidocaine hydrochloride 0.04 MG/MG Topical Gel [Abreva Rapid Pain Relief]SBD3
2637870glycerin 0.2 MG/MG / lidocaine hydrochloride 0.04 MG/MG Topical GelSCD3
2637875Abreva Rapid Pain Relief (glycerin 20 % / lidocaine hydrochloride 4 % ) Topical GelSY3
2637870glycerin 20 % / lidocaine hydrochloride 4 % Topical GelSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0400-01ABREVARapid Pain Relief3 g in 1 TUBEGEL33
0135-0400-01ABREVARapid Pain Relief1 in 1 PACKAGEGEL13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0400ABREVA RAPID PAIN RELIEF (GLYCERIN, LIDOCAINE) GEL [HALEON US HOLDINGS LLC]3Current NDC, 2 package rows20240621_65bd242f-4c6a-436c-8ec0-7b2e0d73ed9d.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0135-04000135-0400-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
METHYLPARABENA2I8C7HI9TIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXACTIB
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ABREVA Rapid Pain ReliefGLYCERIN, LIDOCAINEHaleon US Holdings LLC65bd242f-4c6a-436c-8ec0-7b2e0d73ed9d2024-06-20WarningsExact identifier
ndc (package): 0135-0400-01
ndc (product): 0135-0400
ndc11 (package): 00135040001
spl id: 1b52dd69-d74d-3137-e063-6394a90ab541
spl set id: 65bd242f-4c6a-436c-8ec0-7b2e0d73ed9d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.