Is CalmCo LLC FDA approved?

CalmCo LLC holds no registered establishment of its own; 16 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does CalmCo LLC make?

16 products are listed under CalmCo LLC in the openFDA NDC Directory, most often as chewable gel; solution; bar, chewable. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

CalmCo LLC

Data as of 24 Sept 2026 · How to read this entry

Request a quote Claim this profile

Registered sites: 0
Active NDC listings: 16
Labeller names: 2
Live patents: 0
Countries: 0

Catalogue

Drug listings by form and route

16 active NDC listings: 16 human otc drug. By marketing category: OTC MONOGRAPH DRUG 16.

Dosage form	NDCs
chewable gel	8
solution	5
bar, chewable	3

Route	NDCs
oral	16

Labeller name on the listing	NDCs
calmco llc	15
calmco	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Adult Allergy Relief	CalmCo Allergy Relief	bar, chewable, oral	73282-2520OTC MONOGRAPH DRUG
CalmCo Sleep Aid	Diphenhydramine HCl	chewable gel, oral	73282-2527OTC MONOGRAPH DRUG
CalmCo Sleep Aid	Diphenhydramine HCl	chewable gel, oral	73282-2528OTC MONOGRAPH DRUG
CalmCo Sleep Aid Gummy Bite	Diphenhydramine HCl	bar, chewable, oral	73282-2518OTC MONOGRAPH DRUG
Calmco Allergy Relief	Diphenhydramine HCl	solution, oral	73282-2524OTC MONOGRAPH DRUG
Calmco Allergy Relief	Diphenhydramine HCl	chewable gel, oral	73282-2526OTC MONOGRAPH DRUG
Calmco Allergy Relief	Diphenhydramine HCl	chewable gel, oral	73282-2529OTC MONOGRAPH DRUG
Calmco Sleep Aid	Diphenhydramine HCl	solution, oral	73282-2525OTC MONOGRAPH DRUG
Dr Kids Allergy Relief	Diphenhydramine HCl	solution, oral	73282-2521OTC MONOGRAPH DRUG
Dr Kids Allergy Relief	Diphenhydramine HCl	chewable gel, oral	73282-2530OTC MONOGRAPH DRUG
Dr Kids Allergy Relief	Diphenhydramine HCl	chewable gel, oral	73282-2531OTC MONOGRAPH DRUG
Dr Kids Cough and Chest Congestion	Dextromethorphan HBr, Guaifenesin	solution, oral	73282-2523OTC MONOGRAPH DRUG
Dr Kids Pain and Fever	Acetaminophen	solution, oral	73282-2522OTC MONOGRAPH DRUG
Dr Kids Pain and Fever	Acetaminophen	chewable gel, oral	73282-2532OTC MONOGRAPH DRUG
Dr Kids Pain and Fever	Acetaminophen	chewable gel, oral	73282-2533OTC MONOGRAPH DRUG
DrKids Childrens Pain and Fever	Acetaminophen 80mg/piece	bar, chewable, oral	73282-2480OTC MONOGRAPH DRUG

Compare

Other companies listing diphenhydramine hcl

Cardinal Health 418, Inc.34 sites · 833 NDC
Catalent Pharma Solutions Inc.22 sites · 261 NDC
The Procter & Gamble Manufacturing Company11 sites · 849 NDC
P & L Development, LLC5 sites · 119 NDC
International Medication Systems, Ltd.3 sites · 2,801 NDC
L. Perrigo Company3 sites · 243 NDC
Proficient Rx LP1 site · 1,729 NDC
NuCare Pharmaceuticals,Inc.1 site · 1,393 NDC
Preferred Pharmaceuticals Inc.1 site · 1,046 NDC
PD-Rx Pharmaceuticals Inc.1 site · 828 NDC

Enquiry

Common questions

Is CalmCo LLC FDA approved?: CalmCo LLC holds no registered establishment of its own; 16 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does CalmCo LLC make?: 16 products are listed under CalmCo LLC in the openFDA NDC Directory, most often as chewable gel; solution; bar, chewable. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.