baby oral pain relief

Generic: oyster shell calcium carbonate, crude, tribasic calcium phosphate, arabica coffee bean, arnica montana, ferrum phosphoricum and matricaria chamomilla

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

Drug Facts

Product Profile

Brand Name baby oral pain relief
Generic Name oyster shell calcium carbonate, crude, tribasic calcium phosphate, arabica coffee bean, arnica montana, ferrum phosphoricum and matricaria chamomilla
Labeler hyland' inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

arabica coffee bean 6 [hp_X]/g, arnica montana 30 [hp_X]/g, ferrum phosphoricum 12 [hp_X]/g, matricaria chamomilla 12 [hp_X]/g, oyster shell calcium carbonate, crude 12 [hp_X]/g, tribasic calcium phosphate 12 [hp_X]/g

Manufacturer
Hyland' Inc.

Identifiers & Regulatory

Product NDC 54973-3315
Product ID 54973-3315_2d83ba02-987c-b74b-e063-6294a90a6dc0
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 549733315
Hyphenated Format 54973-3315

Supplemental Identifiers

UNII
3SW678MX72 O80TY208ZW 91GQH8I5F7 G0R4UBI2ZZ 2E32821G6I 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 oral pain relief (source: ndc)
Generic Name oyster shell calcium carbonate, crude, tribasic calcium phosphate, arabica coffee bean, arnica montana, ferrum phosphoricum and matricaria chamomilla (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 (54973-3315-1) / 125 g in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (54973-3315-7) / 80 g in 1 BOTTLE, PLASTIC
source: ndc

Packages (2)

54973-3315-1 1 BOTTLE, PLASTIC in 1 CARTON (54973-3315-1) / 125 g in 1 BOTTLE, PLASTIC 54973-3315-7 1 BOTTLE, PLASTIC in 1 CARTON (54973-3315-7) / 80 g in 1 BOTTLE, PLASTIC

Ingredients (6)

arabica coffee bean (6 [hp_X]/g) arnica montana (30 [hp_X]/g) ferrum phosphoricum (12 [hp_X]/g) matricaria chamomilla (12 [hp_X]/g) oyster shell calcium carbonate, crude (12 [hp_X]/g) tribasic calcium phosphate (12 [hp_X]/g)

Linked Drug Pages (1)

Baby Oral Pain Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2d83ba02-987c-b74b-e063-6294a90a6dc0", "openfda": {"nui": ["N0000185371", "N0000185375", "N0000175629", "N0000184306", "M0000728", "M0006342", "M0016962", "M0516536"], "unii": ["3SW678MX72", "O80TY208ZW", "91GQH8I5F7", "G0R4UBI2ZZ", "2E32821G6I", "91D9GV0Z28"], "spl_set_id": ["5904f126-e8f0-a892-e053-2991aa0aef0f"], "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 (54973-3315-1)  / 125 g in 1 BOTTLE, PLASTIC", "package_ndc": "54973-3315-1", "marketing_start_date": "20170817"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (54973-3315-7)  / 80 g in 1 BOTTLE, PLASTIC", "package_ndc": "54973-3315-7", "marketing_start_date": "20170817"}], "brand_name": "Baby Oral Pain Relief", "product_id": "54973-3315_2d83ba02-987c-b74b-e063-6294a90a6dc0", "dosage_form": "TABLET", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Dietary Proteins [CS]", "Increased Histamine Release [PE]", "Non-Standardized Food Allergenic Extract [EPC]", "Non-Standardized Plant Allergenic Extract [EPC]", "Plant Proteins [CS]", "Seed Storage Proteins [CS]"], "product_ndc": "54973-3315", "generic_name": "oyster shell calcium carbonate, crude, tribasic calcium phosphate, arabica coffee bean, arnica montana, ferrum phosphoricum and matricaria chamomilla", "labeler_name": "Hyland' Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Baby Oral Pain Relief", "active_ingredients": [{"name": "ARABICA COFFEE BEAN", "strength": "6 [hp_X]/g"}, {"name": "ARNICA MONTANA", "strength": "30 [hp_X]/g"}, {"name": "FERRUM PHOSPHORICUM", "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": "TRIBASIC CALCIUM PHOSPHATE", "strength": "12 [hp_X]/g"}], "marketing_category": "UNAPPROVED HOMEOPATHIC", "marketing_start_date": "20170817", "listing_expiration_date": "20261231"}