FDA.reportPublic FDA data

Tecnu Calagel

Manufacturer
Tec Laboratories Inc.
Effective date
2026-04-20
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:54:27

Label at a glance#

ProductTecnu Calagel
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

for temporary relief of pain and itching associated with: •minor burns •sunburn •minor cuts •scrapes •insect bites •minor skin irritations rashes due to: •poison oak •poison ivy •poison sumac

Dosage and administration

Directions •do not use more often than directed •adults and children 2 years of age and older: apply to affected area not more than 3 times daily •children under 2 years of age do not use, consult a doctor

Storage and handling

Store at 59 to 86ºF (15 to 30ºC)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCL 2%

Purpose

OTC - PURPOSE SECTION

Purpose Topical analgesic / antihistamine

Uses

INDICATIONS & USAGE SECTION

for temporary relief of pain and itching associated with:

•minor burns •sunburn •minor cuts •scrapes •insect bites

•minor skin irritations

rashes due to: •poison oak •poison ivy •poison sumac

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

On chicken pox, poison ivy, sunburn, large areas of the body, broken, blistered, or oozing skin, more often than directed, or with any other product containing diphenhydramine, even one taken by mouth.

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
  • symptoms persist for 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 ceneter right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions •do not use more often than directed

•adults and children 2 years of age and older:

apply to affected area not more than 3 times daily

•children under 2 years of age do not use, consult a doctor

Other Information

STORAGE AND HANDLING SECTION

Store at 59 to 86ºF (15 to 30ºC)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

benzethonium chloride, disodium EDTA, fragrance, hypromellose,

menthol, polysorbate 20, purified water, sodium metabisulfite, zinc acetate

Questions?

OTC - QUESTIONS SECTION

Call 1-800-650-0113

Calagel 6oz Bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

Carton - 144 Single-Use Packets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CARTONCARTON

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2174801CALAGEL 2 % Topical GelPSN8
1049880diphenhydrAMINE HCl 2 % Topical GelPSN8
2174801diphenhydramine hydrochloride 0.02 MG/MG Topical Gel [Calagel Reformulated Jun 2019]SBD8
1049880diphenhydramine hydrochloride 0.02 MG/MG Topical GelSCD8
2174801Calagel Reformulated Jun 2019 0.02 MG/MG Topical GelSY8
2174801Calagel Reformulated Jun 2019 2 % Topical GelSY8
1049880diphenhydramine hydrochloride 2 % Topical GelSY8

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51879-802-06Tecnu Calagel1 in 1 CARTONGEL18
51879-802-16Tecnu Calagel1.86 g in 1 PACKETGEL1.868
51879-802-44Tecnu Calagel144 in 1 CARTONGEL1448
51879-802-66Tecnu Calagel178.9 g in 1 BOTTLEGEL178.98

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51879-80251879-802-66, 51879-802-06, 51879-802-16, 51879-802-44

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYSORBATE 207T1F30V5YHIACT
ZINC ACETATEFM5526K07AIACT
HYPROMELLOSE 2208 (100 MPA.S)B1QE5P712KIACT
WATER059QF0KO0RIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
BENZETHONIUM CHLORIDEPH41D05744IACT
SODIUM METABISULFITE4VON5FNS3CIACT
EDETATE DISODIUM7FLD91C86KIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72025-10-17monthly-update2026-06-03 17:39:16
62024-11-05full-release2026-06-01 00:34:30

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
Tecnu CalagelDIPHENHYDRAMINE HYDROCHLORIDETec Laboratories Inc.8bc9cbfe-1dd4-18ed-e053-2a95a90a79662026-04-20WarningsExact identifier
ndc (package): 51879-802-06
ndc (package): 51879-802-66
ndc (package): 51879-802-44
ndc (package): 51879-802-16
ndc (product): 51879-802
ndc11 (package): 51879080266
ndc11 (package): 51879080216
ndc11 (package): 51879080244
ndc11 (package): 51879080206
spl id: 4fece5ab-b042-c2ec-e063-6294a90affff
spl set id: 8bc9cbfe-1dd4-18ed-e053-2a95a90a7966

Reported adverse events (FAERS/openFDA)#

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