onedrop

Generic: propylene glycol

Labeler: laboratorios sophia, s.a. de c.v.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name onedrop
Generic Name propylene glycol
Labeler laboratorios sophia, s.a. de c.v.
Dosage Form LIQUID
Routes
OPHTHALMIC
Active Ingredients

propylene glycol .6 g/100mL

Manufacturer
LABORATORIOS SOPHIA, S.A. DE C.V.

Identifiers & Regulatory

Product NDC 57619-306
Product ID 57619-306_3cb9857f-529c-ad6c-e063-6294a90aa418
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M018
Listing Expiration 2026-12-31
Marketing Start 2025-08-18

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57619306
Hyphenated Format 57619-306

Supplemental Identifiers

RxCUI
1041798
UPC
0860007365874
UNII
6DC9Q167V3

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 onedrop (source: ndc)
Generic Name propylene glycol (source: ndc)
Application Number M018 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .6 g/100mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 BOX (57619-306-01) / 10 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 BOX (57619-306-02) / 10 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (2)

57619-306-01 1 BOTTLE, DROPPER in 1 BOX (57619-306-01) / 10 mL in 1 BOTTLE, DROPPER 57619-306-02 1 BOTTLE, DROPPER in 1 BOX (57619-306-02) / 10 mL in 1 BOTTLE, DROPPER

Ingredients (1)

propylene glycol (.6 g/100mL)

Linked Drug Pages (1)

OneDrop ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "3cb9857f-529c-ad6c-e063-6294a90aa418", "openfda": {"upc": ["0860007365874"], "unii": ["6DC9Q167V3"], "rxcui": ["1041798"], "spl_set_id": ["3cb9857f-529b-ad6c-e063-6294a90aa418"], "manufacturer_name": ["LABORATORIOS SOPHIA, S.A. DE C.V."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 BOX (57619-306-01)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "57619-306-01", "marketing_start_date": "20250818"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 BOX (57619-306-02)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "57619-306-02", "marketing_start_date": "20250818"}], "brand_name": "OneDrop", "product_id": "57619-306_3cb9857f-529c-ad6c-e063-6294a90aa418", "dosage_form": "LIQUID", "product_ndc": "57619-306", "generic_name": "Propylene Glycol", "labeler_name": "LABORATORIOS SOPHIA, S.A. DE C.V.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "OneDrop", "active_ingredients": [{"name": "PROPYLENE GLYCOL", "strength": ".6 g/100mL"}], "application_number": "M018", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250818", "listing_expiration_date": "20261231"}