Labeler · US market

Cardinal Health

Cardinal Health is a US drug labeler with US FDA registrations covering 79 drug concepts (70 currently active) across 118 packages. It is currently the only active US supplier of 8 drugs. The company files with FDA under 2 name variants, merged into this profile.

Also files as: CARDINAL HEALTH, INC.

ACTIVE — US

openFDA · updated weekly

Labeler codes63517 · 70000

Active drugs70

Registrations85 active / 96

Packages118

Sole supplier of8 drugs

Portfolio79 drugs · US

Every drug concept this labeler has US registrations for, by package count.

Drug	Type	NDCs	Packages	Status
Nicotine Transdermal System patch, extended release	otc	3	6	SUPPLYING
Isopropyl Alcohol swab	otc	4	4	SUPPLYING
Omeprazole tablet, delayed release	otc	1	4	SUPPLYING
Barrier Cream ointment	otc	1	3	SUPPLYING
Calcium Carbonate tablet, chewable	otc	3	3	SUPPLYING
Phenazopyridine Hydrochloride tablet	rx	3	3	SUPPLYING
Skin Protectant ointment	otc	1	3	SUPPLYING
Polyethylene Glycol 400, Propylene Glycol solution/ drops	otc	3	3	SUPPLYING
Ketotifen Fumarate solution	otc	1	2	SUPPLYING
Aluminum Hydroxide, Magnesium Hydroxide, Dimethicone suspension	otc	2	2	SUPPLYING
Avobenzone, Homosalate, Octisalate, Octocrylene spray	otc	2	2	SUPPLYING
Sennosides tablet	otc	2	2	SUPPLYING
Esomeprazole Magnesium tablet, delayed release	otc	1	2	SUPPLYING
Loratadine And Pseudoephedrine Sulfate tablet, film coated, extended release	otc	1	2	SUPPLYING
Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride tablet, film coated, extended release	otc	1	2	SUPPLYING
Loratadine tablet	rx	1	2	SUPPLYING
Ibuprofen tablet	rx	1	2	SUPPLYING
Avobenzone, Homosalate, Octisalate, Octocrylene lotion	otc	2	2	SUPPLYING
Bisacodyl suppository	otc	1	2	SUPPLYING
Carboxymethylcellulose Sodium solution/ drops	otc	1	2	SUPPLYING
Glycerin, Naphazoline Hydrochloride solution/ drops	otc	1	2	SUPPLYING
Adapalene gel	rx	1	2	SUPPLYING
Diphenhydramine Hydrochloride liquid	otc	1	2	SUPPLYING
Magnesium Hydroxide suspension	otc	2	2	SUPPLYING
Glycerin suppository	otc	2	2	SUPPLYING
Aluminum Chlorohydrate solution	otc	1	1	SUPPLYING
Phenylephrine Hydrochloride spray	otc	1	1	SUPPLYING
Anti-Fungal Powder Miconazole Nitrate Talc Free powder	otc	1	1	SUPPLYING
Olopatadine Hydrochloride solution	otc	1	1	SUPPLYING
Lidocaine cream	otc	1	1	SUPPLYING
Acetaminophen tablet	otc	1	1	SUPPLYING
Aspirin tablet, coated	otc	1	1	SUPPLYING
Benzalkonium Chloride cloth	otc	1	1	SUPPLYING
Alcohol cloth	otc	1	1	SUPPLYING
Isopropyl Alcohol cloth	otc	1	1	SUPPLYING
Witch Hazel cloth	otc	1	1	SUPPLYING
Lidocaine Hcl liquid	otc	1	1	SUPPLYING
Aluminum Hydroxide And Magnesium Carbonate tablet, chewable	otc	1	1	SUPPLYING
Pseudoephedrine Hydrochloride tablet, film coated	otc	1	1	SUPPLYING
Guaifenesin tablet	otc	1	1	SUPPLYING

Showing 40 of 79 drugs by package count.

Sole US supplier

Drugs where this labeler is currently the only active US supplier — a single point of failure if it exits.

At a glance

TypeLabeler
Labeler codes63517, 70000
Filing names2
Drugs (active)70
Drugs (all time)79
US registrations96
Packages118

Recent events

Shortages, recalls, and registration changes across all filing names.

Aug 5, 2025
RECALLRecall (Class II): Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled syringes further packaged in bags of 5 pre…
Jul 30, 2025
RECALLRecall (Class II): Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55
Jul 30, 2025
RECALLRecall (Class II): Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: …
Jul 30, 2025
RECALLRecall (Class II): RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 0214…
Apr 9, 2025
RECALLRecall (Class II): Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subcutaneous Use Only, Rx …
Oct 31, 2023
RECALLRecall (Class I): LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 0.5 FL OZ (15 mL) dropper bottles, Sterile, Dis…
Oct 31, 2023
RECALLRecall (Class I): LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 2 bottles, 0.5 FL OZ (15 mL) dropper bottles, S…
Oct 31, 2023
RECALLRecall (Class I): LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, 0.3%); 0.33 FL OZ (10 mL) dropper bottle, …

Watch this company

Alerts for recalls, exits, and new registrations.

Facility locations, FDA inspections, and parent-company mapping are on the roadmap. Name variants reported to FDA under different spellings are merged into this profile (see “Also files as” above); figures cover the entity across all its filing names.