Home NDC 57619-400-01 Manzanilla
Product NDC 57619-400
Requested package NDC 57619-400-01
11-digit product format 576190400
Labeler code 57619
Product ID 57619-400_d1162ce5-464d-76f8-e053-2a95a90abcf4
Type HUMAN OTC DRUG
Nonproprietary name Chamomile (Matricaria Chamomilla L.)
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler LABORATORIOS SOPHIA, S.A. DE C.V.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2010-04-12
Marketing end 0000-00-00
Substance MATRICARIA RECUTITA
Active strength 3 [hp_X]/mL
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 57619-400 57619-400-01 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MATRICARIA RECUTITA ACTIVE INGREDIENT G0R4UBI2ZZ MANZANILLA SOPHIA (CHAMOMILE (MATRICARIA CHAMOMILLA L.)) SOLUTION/ DROPS [LABORATORIOS SOPHIA, S.A. DE C.V.] 6 MATRICARIA RECUTITA ACTIVE MOIETY G0R4UBI2ZZ MANZANILLA SOPHIA (CHAMOMILE (MATRICARIA CHAMOMILLA L.)) SOLUTION/ DROPS [LABORATORIOS SOPHIA, S.A. DE C.V.] 6 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 MANZANILLA SOPHIA (CHAMOMILE (MATRICARIA CHAMOMILLA L.)) SOLUTION/ DROPS [LABORATORIOS SOPHIA, S.A. DE C.V.] 6 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X MANZANILLA SOPHIA (CHAMOMILE (MATRICARIA CHAMOMILLA L.)) SOLUTION/ DROPS [LABORATORIOS SOPHIA, S.A. DE C.V.] 6 SODIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT 22ADO53M6F MANZANILLA SOPHIA (CHAMOMILE (MATRICARIA CHAMOMILLA L.)) SOLUTION/ DROPS [LABORATORIOS SOPHIA, S.A. DE C.V.] 6 SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE INACTIVE INGREDIENT 593YOG76RN MANZANILLA SOPHIA (CHAMOMILE (MATRICARIA CHAMOMILLA L.)) SOLUTION/ DROPS [LABORATORIOS SOPHIA, S.A. DE C.V.] 6 WATER INACTIVE INGREDIENT 059QF0KO0R MANZANILLA SOPHIA (CHAMOMILE (MATRICARIA CHAMOMILLA L.)) SOLUTION/ DROPS [LABORATORIOS SOPHIA, S.A. DE C.V.] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57619-400 MANZANILLA SOPHIA (CHAMOMILE (MATRICARIA CHAMOMILLA L.)) SOLUTION/ DROPS [LABORATORIOS SOPHIA, S.A. DE C.V.] 9 Legacy NDC 20240112_9245ab82-e9fa-48c8-a412-a5cbc47e6033.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 57619-400-01 57619040001 1 BOTTLE, PLASTIC in 1 PACKAGE (57619-400-01) > 15 mL in 1 BOTTLE, PLASTIC 2010-04-12 0000-00-00 No No Current