baby nighttime oral pain relief

Generic: arnica montana, tribasic calcium phosphate, matricaria chamomilla, silicon dioxide, magnesium phosphate, dibasic trihydrate, ferrosoferric phosphate, arabica coffee bean and oyster shell calcium carbonate, crude

Labeler: hyland' inc.
NDC Directory HUMAN OTC DRUG UNAPPROVED HOMEOPATHIC Inactive Finished

Drug Facts

Product Profile

Brand Name baby nighttime oral pain relief
Generic 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
Labeler hyland' inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

arabica coffee bean 6 [hp_X]/g, arnica montana 30 [hp_X]/g, ferrosoferric phosphate 12 [hp_X]/g, magnesium phosphate, dibasic trihydrate 12 [hp_X]/g, matricaria chamomilla 12 [hp_X]/g, oyster shell calcium carbonate, crude 12 [hp_X]/g, silicon dioxide 12 [hp_X]/g, tribasic calcium phosphate 12 [hp_X]/g

Manufacturer
Hyland' Inc.

Identifiers & Regulatory

Product NDC 54973-3324
Product ID 54973-3324_308ccf50-c319-2cd0-e063-6394a90aa99e
Product Type HUMAN OTC DRUG
Marketing Category UNAPPROVED HOMEOPATHIC
Listing Expiration 2026-12-31
Marketing Start 2017-08-17

Pharmacologic Class

Established (EPC)
non-standardized food allergenic extract [epc] non-standardized plant allergenic extract [epc]
Chemical Structure
allergens [cs] dietary proteins [cs] plant proteins [cs] seed storage proteins [cs]
Physiologic Effect
increased histamine release [pe] cell-mediated immunity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 549733324
Hyphenated Format 54973-3324

Supplemental Identifiers

UNII
3SW678MX72 O80TY208ZW 91GQH8I5F7 HF539G9L3Q G0R4UBI2ZZ 2E32821G6I ETJ7Z6XBU4 91D9GV0Z28
NUI
N0000185371 N0000185375 N0000175629 N0000184306 M0000728 M0006342 M0016962 M0516536

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name baby nighttime oral pain relief (source: ndc)
Generic 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 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 6 [hp_X]/g
  • 30 [hp_X]/g
  • 12 [hp_X]/g
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (54973-3324-1) / 1 g in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

54973-3324-1 1 BOTTLE, PLASTIC in 1 CARTON (54973-3324-1) / 1 g in 1 BOTTLE, PLASTIC

Ingredients (8)

arabica coffee bean (6 [hp_X]/g) arnica montana (30 [hp_X]/g) ferrosoferric phosphate (12 [hp_X]/g) magnesium phosphate, dibasic trihydrate (12 [hp_X]/g) matricaria chamomilla (12 [hp_X]/g) oyster shell calcium carbonate, crude (12 [hp_X]/g) silicon dioxide (12 [hp_X]/g) tribasic calcium phosphate (12 [hp_X]/g)

Linked Drug Pages (1)

Baby Nighttime Oral Pain Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "308ccf50-c319-2cd0-e063-6394a90aa99e", "openfda": {"nui": ["N0000185371", "N0000185375", "N0000175629", "N0000184306", "M0000728", "M0006342", "M0016962", "M0516536"], "unii": ["3SW678MX72", "O80TY208ZW", "91GQH8I5F7", "HF539G9L3Q", "G0R4UBI2ZZ", "2E32821G6I", "ETJ7Z6XBU4", "91D9GV0Z28"], "spl_set_id": ["58ef86b7-5b38-1591-e053-2991aa0aa53e"], "pharm_class_cs": ["Allergens [CS]", "Dietary Proteins [CS]", "Plant Proteins [CS]", "Seed Storage Proteins [CS]"], "pharm_class_pe": ["Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]"], "pharm_class_epc": ["Non-Standardized Food Allergenic Extract [EPC]", "Non-Standardized Plant Allergenic Extract [EPC]"], "manufacturer_name": ["Hyland' Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (54973-3324-1)  / 1 g in 1 BOTTLE, PLASTIC", "package_ndc": "54973-3324-1", "marketing_start_date": "20170817"}], "brand_name": "Baby Nighttime Oral Pain Relief", "product_id": "54973-3324_308ccf50-c319-2cd0-e063-6394a90aa99e", "dosage_form": "TABLET", "pharm_class": ["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]"], "product_ndc": "54973-3324", "generic_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", "labeler_name": "Hyland' Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Baby Nighttime Oral Pain Relief", "active_ingredients": [{"name": "ARABICA COFFEE BEAN", "strength": "6 [hp_X]/g"}, {"name": "ARNICA MONTANA", "strength": "30 [hp_X]/g"}, {"name": "FERROSOFERRIC PHOSPHATE", "strength": "12 [hp_X]/g"}, {"name": "MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE", "strength": "12 [hp_X]/g"}, {"name": "MATRICARIA CHAMOMILLA", "strength": "12 [hp_X]/g"}, {"name": "OYSTER SHELL CALCIUM CARBONATE, CRUDE", "strength": "12 [hp_X]/g"}, {"name": "SILICON DIOXIDE", "strength": "12 [hp_X]/g"}, {"name": "TRIBASIC CALCIUM PHOSPHATE", "strength": "12 [hp_X]/g"}], "marketing_category": "UNAPPROVED HOMEOPATHIC", "marketing_start_date": "20170817", "listing_expiration_date": "20261231"}