NDC 10237-908

Baby Orajel Naturals

Calceria Carbonica, Calceria Phosphorica, Chamomilla, Coffea Cruda, Passiflora Incarnata, Terebinthina

Baby Orajel Naturals is a Sublingual Tablet, Orally Disintegrating in the Human Otc Drug category. It is labeled and distributed by Church & Dwight Co., Inc.. The primary component is Passiflora Incarnata Flowering Top; Turpentine Oil; Oyster Shell Calcium Carbonate, Crude; Matricaria Recutita; Arabica Coffee Bean; Tribasic Calcium Phosphate.

• Product ID: 10237-908_26545e80-8c0d-2424-e054-00144ff88e88
• NDC: 10237-908
• Product Type: Human Otc Drug
• Proprietary Name: Baby Orajel Naturals
• Generic Name: Calceria Carbonica, Calceria Phosphorica, Chamomilla, Coffea Cruda, Passiflora Incarnata, Terebinthina
• Dosage Form: Tablet, Orally Disintegrating
• Route of Administration: SUBLINGUAL
• Marketing Start Date: 2016-01-18
• Marketing Category: UNAPPROVED HOMEOPATHIC / UNAPPROVED HOMEOPATHIC
• Labeler Name: Church & Dwight Co., Inc.
• Substance Name: PASSIFLORA INCARNATA FLOWERING TOP; TURPENTINE OIL; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MATRICARIA RECUTITA; ARABICA COFFEE BEAN; TRIBASIC CALCIUM PHOSPHATE
• Active Ingredient Strength: 6 1/[hp_X]; 1/[hp_X]; 1/[hp_X]; 1/[hp_X]; 1/[hp_X]; 1/[hp_X]
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 10237-908-12

1 BOTTLE, PLASTIC in 1 CARTON (10237-908-12) > 135 [hp_X] in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2016-01-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 10237-908-12 [10237090812]

Baby Orajel Naturals TABLET, ORALLY DISINTEGRATING

• Marketing Category: unapproved homeopathic
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-01-18
• Marketing End Date: 2018-09-24

Drug Details

Active Ingredients

Ingredient	Strength
PASSIFLORA INCARNATA FLOWERING TOP	6 1/[hp_X]

OpenFDA Data

• SPL SET ID: 26545e80-8c0c-2424-e054-00144ff88e88
• Manufacturer:
  • Church & Dwight Co., Inc.
• UNII:
  • CLF5YFS11O
  • C5H0QJ6V7F
  • 91D9GV0Z28
  • 2E32821G6I
  • G0R4UBI2ZZ
  • 3SW678MX72

NDC Crossover Matching brand name "Baby Orajel Naturals" or generic name "Calceria Carbonica, Calceria Phosphorica, Chamomilla, Coffea Cruda, Passiflora Incarnata, Terebinthina"

NDC	Brand Name	Generic Name
10237-742	Baby Orajel Naturals	Calcarea phosphorica, Chamomilla, Coffea cruda
10237-903	Baby Orajel Naturals	Calcarea phosphorica, Coffea cruda, Chamomilla
10237-908	Baby Orajel Naturals	Calceria carbonica, Calceria phosphorica, Chamomilla, Coffea cruda, Passiflora incarnata, Terebinthina
62864-903	Baby Orajel Naturals	Calcarea phosphorica, Coffea cruda, Chamomilla