Tecnu Calagel

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Tecnu Calagel
Generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Manufacturer: Tec Laboratories Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 8bc9cbfe-1dd4-18ed-e053-2a95a90a7966
SPL ID: 4fece5ab-b042-c2ec-e063-6294a90affff
Version: 8
Effective date: 2026-04-20
Source export date: 2026-09-28
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:48:51

Harmonized routes table
Harmonized routes
TOPICAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 18 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M017	openfda.application_number
brand name		Tecnu Calagel	openfda.brand_name
generic name		DIPHENHYDRAMINE HYDROCHLORIDE	openfda.generic_name
manufacturer name		Tec Laboratories Inc.	openfda.manufacturer_name
ndc	package	51879-802-06	openfda.package_ndc
ndc	package	51879-802-66	openfda.package_ndc
ndc	package	51879-802-44	openfda.package_ndc
ndc	package	51879-802-16	openfda.package_ndc
ndc	product	51879-802	openfda.product_ndc
ndc11	package	51879080266	derived:openfda.package_ndc
ndc11	package	51879080216	derived:openfda.package_ndc
ndc11	package	51879080244	derived:openfda.package_ndc
ndc11	package	51879080206	derived:openfda.package_ndc
rxcui		1049880	openfda.rxcui
rxcui		2174801	openfda.rxcui
spl id		4fece5ab-b042-c2ec-e063-6294a90affff	id
spl set id		8bc9cbfe-1dd4-18ed-e053-2a95a90a7966	set_id
unii		TC2D6JAD40	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For external use only Do not use 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 avoid contact with eyes Stop use and ask a doctor if 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 If swallowed, get medical help or contact a poison control ceneter right away.

Reported adverse events (FAERS/openFDA)#

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