Home NDC 67510-0663-5 Eye Lubricant
Product NDC 67510-0663
Requested package NDC 67510-0663-5
11-digit product format 675100663
Labeler code 67510
Product ID 67510-0663_d450c339-baf6-0434-e053-2995a90a2717
Type HUMAN OTC DRUG
Nonproprietary name polyethylene gloycol, propylene glycol
Dosage form LIQUID
Route OPHTHALMIC
Labeler Kareway Product, Inc.
Application part349
Marketing category OTC MONOGRAPH FINAL
Marketing start 2012-10-01
Marketing end 0000-00-00
Substance POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL
Active strength 4 mg/mL; mg/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 2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 67510-0663 67510-0663-5 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded POLYETHYLENE GLYCOL 400 ACTIVE INGREDIENT B697894SGQ EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.] 2 POLYETHYLENE GLYCOL 400 ACTIVE INGREDIENT B697894SGQ EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.] 2 PROPYLENE GLYCOL ACTIVE INGREDIENT 6DC9Q167V3 EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.] 2 PROPYLENE GLYCOL ACTIVE INGREDIENT 6DC9Q167V3 EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.] 2 POLYETHYLENE GLYCOL 400 ACTIVE MOIETY B697894SGQ EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.] 2 POLYETHYLENE GLYCOLS ACTIVE MOIETY 3WJQ0SDW1A EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.] 2 PROPYLENE GLYCOL ACTIVE MOIETY 6DC9Q167V3 EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.] 2 PROPYLENE GLYCOL ACTIVE MOIETY 6DC9Q167V3 EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.] 2 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.] 2 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.] 2 BORIC ACID INACTIVE INGREDIENT R57ZHV85D4 EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.] 2 BORIC ACID INACTIVE INGREDIENT R57ZHV85D4 EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.] 2 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.] 2 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.] 2 POTASSIUM CHLORIDE INACTIVE INGREDIENT 660YQ98I10 EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.] 2 POTASSIUM CHLORIDE INACTIVE INGREDIENT 660YQ98I10 EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.] 2 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.] 2 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 67510-0663-5 67510066305 1 BOTTLE in 1 BOX (67510-0663-5) > 15 mL in 1 BOTTLE 1 bottle 2012-10-02 0000-00-00 No No Current