NDC 57619-400

Manzanilla Sophia

Chamomile (matricaria Chamomilla L.)

Manzanilla Sophia is a Ophthalmic Solution/ Drops in the Human Otc Drug category. It is labeled and distributed by Laboratorios Sophia, S.a. De C.v.. The primary component is Matricaria Recutita.

• Product ID: 57619-400_1daa86fa-4ead-1e90-e054-00144ff88e88
• NDC: 57619-400
• Product Type: Human Otc Drug
• Proprietary Name: Manzanilla Sophia
• Generic Name: Chamomile (matricaria Chamomilla L.)
• Dosage Form: Solution/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2010-04-12
• Marketing Category: UNAPPROVED HOMEOPATHIC / UNAPPROVED HOMEOPATHIC
• Labeler Name: LABORATORIOS SOPHIA, S.A. DE C.V.
• Substance Name: MATRICARIA RECUTITA
• Active Ingredient Strength: 3 [hp_X]/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 57619-400-01

1 BOTTLE, PLASTIC in 1 PACKAGE (57619-400-01) > 15 mL in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2010-04-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 57619-400-01 [57619040001]

Manzanilla Sophia SOLUTION/ DROPS

• Marketing Category: unapproved homeopathic
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2010-04-12

Drug Details

Active Ingredients

Ingredient	Strength
MATRICARIA RECUTITA	3 [hp_X]/mL

OpenFDA Data

• SPL SET ID: 9245ab82-e9fa-48c8-a412-a5cbc47e6033
• Manufacturer:
  • LABORATORIOS SOPHIA, S.A. DE C.V.
• UNII:
  • G0R4UBI2ZZ
• UPC Code:
  • 0736085408485

NDC Crossover Matching brand name "Manzanilla Sophia" or generic name "Chamomile (matricaria Chamomilla L.)"

NDC	Brand Name	Generic Name
69772-500	Manzanilla Sophia	Matricaria recutita
57619-400	Manzanilla	Chamomile (Matricaria Chamomilla L.)