Labeler · US market

Schwabe North America, inc.

Schwabe North America, inc. is a US drug labeler with US FDA registrations covering 40 drug concepts (35 currently active) across 70 packages. It is currently the only active US supplier of 17 drugs. The company files with FDA under 3 name variants, merged into this profile.

Also files as: Schwabe North America · Schwabe North American, Inc.

ACTIVE — US

openFDA · updated weekly

Labeler codes53499 · 59800

Active drugs35

Registrations49 active / 60

Packages70

Sole supplier of17 drugs

Portfolio40 drugs · US

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

Drug	Type	NDCs	Packages	Status
Pelargonium Sidoides liquid	otc	7	10	SUPPLYING
Pelargonium Sidoides syrup	otc	5	8	SUPPLYING
Pelargonium Sidoides tablet, chewable	otc	3	3	SUPPLYING
Aconitum Napellus, Bryonia Alba Root, Eucalyptus Globulus Leaf, Eupatorium Perfoliatum Flowering Top, Gelsemium Sempervirens Root, Ipecac, Phosphorus, tablet	otc	3	3	SUPPLYING
Matricaria Recutita, Humulus Lupulus Whole, Passiflora Incarnata Top powder	other	2	2	SUPPLYING
Pelargonium Sidoides, Aconitum Napellus, Bryonia, Eucalyptus Globulus, Eupatorium Perfoliatum, Gelsemium Sempervirens, Ipecacuanha, Phosphorus tablet, chewable	otc	2	2	SUPPLYING
Guaifenesin tablet	otc	2	2	SUPPLYING
Aconitum Napellus, Bryonia Alba Root, Calcium Cation, Spongia Officinalis Skeleton, Roasted, Tin syrup	otc	1	2	SUPPLYING
Aconitum Napellus, Bryonia Root, Calcium Cation, Spongia Officinalis Skeleton, Roasted, Tin, Medicago Sativa Leaf, Oat, Arabica Coffee Bean syrup	otc	1	2	SUPPLYING
Pelargonium Sidoides powder	otc	2	2	SUPPLYING
Aconitum Napellus, Bryonia Alba Root, Calcium Sulfide, Spongia Officinalis Skeleton, Roasted, Tin syrup	otc	1	2	SUPPLYING
Pelargonium Sidoides Root, Aconitum Napellus, Eucalyptus Globulus Leaf, Sambucus Nigra Flowering Top, Bryonia Alba Root, Eupatorium Perfoliatum Flowering Top, Gelsemium Sempervirens Root, Phosphorus, Ipecac tablet, chewable	otc	2	2	SUPPLYING
Sambucus Nigra Flowering Top powder	other	2	2	SUPPLYING
Pelargonium Sidoides powder	other	1	1	SUPPLYING
Cold Flu Relief Berry powder	otc	1	1	SUPPLYING
Cold Relief Day Plus Night kit	otc	1	1	SUPPLYING
Toxicodendron Pubescens Leaf liquid	otc	1	1	SUPPLYING
Hydrastis Canadensis, Kali Muriaticum, Pulsatilia Pratensis, Sanguinaria Canadensis, Silicea powder	other	1	1	SUPPLYING
Coffea Cruda powder	other	1	1	SUPPLYING
Alfalfa powder	other	1	1	SUPPLYING
Avena Sativa powder	other	1	1	SUPPLYING
Cold Flu Relief Berry syrup	otc	1	1	SUPPLYING
Mahonia Aquifolium Root Bark cream	otc	1	1	SUPPLYING
Echinacea Angustifolia, Ledum Palustre Twig, Urtica Dioica, gel	otc	1	1	SUPPLYING
Arnica Montana gel	otc	1	1	SUPPLYING
Cough Relief syrup	otc	1	1	SUPPLYING
Bellis Perennis, Hypericum Perfomatum,toxicodendron Pubscens Leaf, Ruta Graveolens Flowering Top gel	otc	1	1	SUPPLYING
Aconitum Napellus, Bryonia Alba Root, Calcium Sulfide, Spongia Officinalis Skeleton, Roasted, Stannous Cation powder	other	1	1	SUPPLYING
Cold Flu Relief Orange tablet, chewable	otc	1	1	SUPPLYING
Pelargonium Sidoides Root, Hydrastis Canadensis Whole, Potassium Chloride, Sanguinaria Canadensis Root, Pulsatilla Vulgaris, Silicon Dioxide tablet, chewable	otc	1	1	SUPPLYING
Cardiospermum Halicacabum Flowering Top cream	otc	1	1	SUPPLYING
Sambucus Cold Flu Relief Elderberry syrup	otc	1	1	SUPPLYING
Cold Flu Relief Elderberry syrup	otc	1	1	SUPPLYING
Urtica Doicia, Rhus Toxicodendron, Ledum Palustre gel	otc	1	1	SUPPLYING
Cardiospermum Halicacabum Flowering Top, Galphimia Glauca Flowering Top, Luffa Operculata Fruit tablet	otc	1	1	SUPPLYING
Arnica Montana tablet	otc	1	2	DISCONTINUED
Arsenic Trioxide, Chamomile, Citrullus Colocynthis Fruit Pulp, Sulfur tablet	otc	1	1	DISCONTINUED
Aconitum Napellus, Calcium Sulfide, Spongia Officinalis Skeleton, Roasted, Tin tablet	otc	1	1	DISCONTINUED
Cyclamen Purpurascens Tuber, Black Cohosh, Iris Versicolor Whole, Gelsemium Sempervirens Whole, Sanguinaria Canadensis Root tablet	otc	1	1	DISCONTINUED
Sanguinaria Canadensis Root, Goldenseal, Silicon Dioxide, Potassium Chloride, Pulsatilla Vulgaris tablet	otc	1	1	DISCONTINUED

Sole US supplier

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

+7 more

At a glance

TypeLabeler
Labeler codes53499, 59800
Filing names3
Drugs (active)35
Drugs (all time)40
US registrations60
Packages70

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.