Baby Nighttime Oral Pain Relief

Product NDC

54973-3324

11-digit product format

549733324

Labeler code

54973

Product ID

54973-3324_308ccf50-c319-2cd0-e063-6394a90aa99e

Type

HUMAN OTC DRUG

Nonproprietary name

Arnica Montana, Tribasic Calcium Phosphate, Matricaria Chamomilla, Silicon Dioxide, Magnesium Phosphate, Dibasic Trihydrate, Ferrosoferric Phosphate, Arabica Coffee Bean and Oyster Shell Calcium Carbonate, Crude

Dosage form

TABLET

Route

ORAL

Labeler

Hyland' Inc.

Marketing category

UNAPPROVED HOMEOPATHIC

Marketing start

2017-08-17

Substance

ARABICA COFFEE BEAN; ARNICA MONTANA; FERROSOFERRIC PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA CHAMOMILLA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SILICON DIOXIDE; TRIBASIC CALCIUM PHOSPHATE

Active strength

6; 30; 12; 12; 12; 12; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g

Pharmacologic classes

Allergens [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]

NDC exclude flag

No

Listing certified through

2026-12-31

Current FDA listing

Yes