Calmco Sleep Aid

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: Calmco Sleep Aid
Generic name: DIPHENHYDRAMINE HCL
Manufacturer: CalmCo LLC
Product type: HUMAN OTC DRUG
SPL set ID: 471d4c70-813a-19de-e063-6394a90aeb25
SPL ID: 4e58cc8b-5c0c-8da6-e063-6394a90a13a0
Version: 2
Effective date: 2026-03-31
Source export date: 2026-09-28
Source partition: 10
Source file: https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:06:54

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 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M010	openfda.application_number
brand name		Calmco Sleep Aid	openfda.brand_name
generic name		DIPHENHYDRAMINE HCL	openfda.generic_name
manufacturer name		CalmCo LLC	openfda.manufacturer_name
ndc	package	73282-2525-2	openfda.package_ndc
ndc	package	73282-2525-1	openfda.package_ndc
ndc	product	73282-2525	openfda.product_ndc
ndc11	package	73282252501	derived:openfda.package_ndc
ndc11	package	73282252502	derived:openfda.package_ndc
spl id		4e58cc8b-5c0c-8da6-e063-6394a90a13a0	id
spl set id		471d4c70-813a-19de-e063-6394a90aeb25	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 . Do not use with any other product containing diphenhydramine, even one used on skin on children under 12 years of age Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma have trouble urinating due to an enlarged prostate gland are taking sedatives or tranquilizers When using this product avoid consuming alcohol beverages Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks.Insomnia may be a symptom of a serious underlying medical illness. If pregnant or breastfeeding, ask a healthcare professional before use KEEP OUT OF REACH OF CHILDREN. In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Reported adverse events (FAERS/openFDA)#

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