NDC 54973-3324

Baby Nighttime Oral Pain Relief

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

Baby Nighttime Oral Pain Relief is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Hyland's. The primary component is Oyster Shell Calcium Carbonate, Crude; Tribasic Calcium Phosphate; Matricaria Chamomilla; Silicon Dioxide; Arnica Montana; Ferrosoferric Phosphate; Arabica Coffee Bean; Magnesium Phosphate, Dibasic Trihydrate.

• Product ID: 54973-3324_71b03f49-4741-2967-e053-2995a90ae089
• NDC: 54973-3324
• Product Type: Human Otc Drug
• Proprietary 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
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2017-08-17
• Marketing Category: UNAPPROVED HOMEOPATHIC / UNAPPROVED HOMEOPATHIC
• Labeler Name: HYLAND'S
• Substance Name: OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; MATRICARIA CHAMOMILLA; SILICON DIOXIDE; ARNICA MONTANA; FERROSOFERRIC PHOSPHATE; ARABICA COFFEE BEAN; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE
• Active Ingredient Strength: 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
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 54973-3324-1

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

• Marketing Start Date: 2017-08-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 54973-3324-1 [54973332401]

Baby Nighttime Oral Pain Relief TABLET

• Marketing Category: unapproved homeopathic
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-08-17

NDC 54973-3324-4 [54973332404]

Baby Nighttime Oral Pain Relief TABLET

• Marketing Category: unapproved homeopathic
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-08-17

Drug Details

Active Ingredients

Ingredient	Strength
OYSTER SHELL CALCIUM CARBONATE, CRUDE	12 [hp_X]/g

OpenFDA Data

• SPL SET ID: 58ef86b7-5b38-1591-e053-2991aa0aa53e
• Manufacturer:
  • HYLAND'S
• UNII:
  • ETJ7Z6XBU4
  • O80TY208ZW
  • 91GQH8I5F7
  • 91D9GV0Z28
  • 2E32821G6I
  • G0R4UBI2ZZ
  • 3SW678MX72
  • HF539G9L3Q
• UPC Code:
  • 0354973332416