FDA.reportPublic FDA data

After Bite Outdoor

Manufacturer
Tender Corporation d/b/a Adventure Ready Brands
Effective date
2025-11-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:16:36

Label at a glance#

ProductAfter Bite Outdoor
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

For temporary relief of pain and itching associated with, minor burns, minor cuts, scrapes, insect bites, minor skin irritations, rashes due to poison ivy, poison oak, and poison sumac.

Dosage and administration

Do not use more often than directed, Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 year of age consult a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 2%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of pain and itching associated with, minor burns, minor cuts, scrapes, insect bites, minor skin irritations, rashes due to poison ivy, poison oak, and poison sumac.

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on large areas of the body, with any other product containing diphenhydramine, even one taken by mouth.

Ask a doctor before use

OTC - ASK DOCTOR SECTION

On chicken pox, on measles

when using this product

OTC - WHEN USING SECTION

Avoid contact with eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

Condition worsens, if symptoms persist 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 Posion Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Do not use more often than directed, Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.

Children under 2 year of age consult a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Vera, Citric Acide, Ethyl Alcohol, Glycerin, Methocel, methylparaben, oat beta glucan, propylparaben, purified water, sodium hydroxide, tea tree oil, vitamine e

After Bute Outdoor Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Primary PackagingPrimary Packaging

After Bite Outdoor Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Secondary PackagingSecondary Packaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049880diphenhydrAMINE HCl 2 % Topical GelPSN2
1049880diphenhydramine hydrochloride 0.02 MG/MG Topical GelSCD2
1049880diphenhydramine hydrochloride 2 % Topical GelSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130044224615602GTIN-13: 0044224615602
EAN-13: 0044224615602
GTIN-12: 044224615602
UPC-A: 044224615602
GTIN storage (14 digits): 00044224615602		After Bite Outdoor USA Box.jpg
Data codeITF00000000After Bite Outdoor USA Box.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44224-1565-0After Bite Outdoor1 g in 1 TUBEGEL12
44224-1565-1After Bite Outdoor1 in 1 BOXGEL12

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44224-156544224-1565-0, 44224-1565-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
TEA TREE OILVIF565UC2GIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
WATER059QF0KO0RIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
ALOE VERA LEAFZY81Z83H0XIACT
METHYLPARABENA2I8C7HI9TIACT
SODIUM HYDROXIDE55X04QC32IIACT
ALCOHOL3K9958V90MIACT
PROPYLPARABENZ8IX2SC1OHIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
GLYCERINPDC6A3C0OXIACT
OATZ6J799EAJKIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

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
After Bite OutdoorDIPHENHYDRAMINE HCLTender Corporation d/b/a Adventure Ready Brands22b891a9-6386-dee1-e063-6394a90a5c2f2025-11-14WarningsExact identifier
ndc (package): 44224-1565-0
ndc (package): 44224-1565-1
ndc (product): 44224-1565
ndc11 (package): 44224156501
ndc11 (package): 44224156500
spl id: 4395c743-e625-1ba6-e063-6294a90a33db
spl set id: 22b891a9-6386-dee1-e063-6394a90a5c2f

Reported adverse events (FAERS/openFDA)#

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