Caffeine

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: Caffeine
Generic name: CAFFEINE
Manufacturer: LEADER/ Cardinal Health 110, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 7c4d61f7-9c6a-61ac-e053-2991aa0a9533
SPL ID: 497945c6-ed39-4111-e063-6394a90a3cf3
Version: 6
Effective date: 2026-01-28
Source export date: 2026-10-30
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-30/9dea423b9e87a781c152bc6e136923fb91acb0732a7a0ec0d2a51142148f160c/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 18:43:06

Harmonized routes table
Harmonized routes
ORAL

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 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M011	openfda.application_number
brand name		Caffeine	openfda.brand_name
generic name		CAFFEINE	openfda.generic_name
manufacturer name		LEADER/ Cardinal Health 110, Inc.	openfda.manufacturer_name
ndc	package	70000-0409-1	openfda.package_ndc
ndc	product	70000-0409	openfda.product_ndc
ndc11	package	70000040901	derived:openfda.package_ndc
rxcui		198520	openfda.rxcui
spl id		497945c6-ed39-4111-e063-6394a90a3cf3	id
spl set id		7c4d61f7-9c6a-61ac-e053-2991aa0a9533	set_id
unii		3G6A5W338E	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 Do not use ■as a substitute for sleep. This product is intended for occasional use only ■in children under 12 years of age When using this product limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee. Stop use and ask a doctor if fatigue or drowsiness persists or continues to recur. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Reported adverse events (FAERS/openFDA)#

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