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: Walgreen Company
Product type: HUMAN OTC DRUG
SPL set ID: c2c7768a-6f9d-d8fe-e053-2995a90a491c
SPL ID: 289e6ff9-4f6f-ed2a-e063-6394a90a8cd1
Version: 4
Effective date: 2024-12-06
Source export date: 2026-10-27
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/b7a5e61d87a3b8f87f4c3ff7b526bfbf6baf84c840f565574c7d83d4083e2b38/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 20:47:28

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		Walgreen Company	openfda.manufacturer_name
ndc	package	0363-5009-01	openfda.package_ndc
ndc	product	0363-5009	openfda.product_ndc
ndc11	package	00363500901	derived:openfda.package_ndc
rxcui		198520	openfda.rxcui
spl id		289e6ff9-4f6f-ed2a-e063-6394a90a8cd1	id
spl set id		c2c7768a-6f9d-d8fe-e053-2995a90a491c	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

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.