Home NDC 67510-0063-5 Tears Lubricant
Product NDC 67510-0063
Requested package NDC 67510-0063-5
11-digit product format 675100063
Labeler code 67510
Product ID 67510-0063_96033323-9233-6160-e053-2995a90aa97d
Type HUMAN OTC DRUG
Nonproprietary name glycerin, hypromelloses, polyethylene glycol 400
Dosage form LIQUID
Route OPHTHALMIC
Labeler Kareway Product, Inc.
Application part349
Marketing category OTC MONOGRAPH FINAL
Marketing start 2018-05-30
Marketing end 0000-00-00
Substance GLYCERIN; HYPROMELLOSES; POLYETHYLENE GLYCOL 400
Active strength 2 mg/mL; mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2020-12-31
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 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 bd6a592717d7…303034d00443…
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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67510-0063-5 Tears Lubricant 15 mL in 1 BOTTLE LIQUID 15 3 67510-0063-5 Tears Lubricant 1 in 1 BOX LIQUID 1 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded GLYCERIN ACTIVE INGREDIENT PDC6A3C0OX TEARS LUBRICANT (GLYCERIN, HYPROMELLOSES, POLYETHYLENE GLYCOL 400) LIQUID [KAREWAY PRODUCT, INC.] 1 HYPROMELLOSES ACTIVE INGREDIENT 3NXW29V3WO TEARS LUBRICANT (GLYCERIN, HYPROMELLOSES, POLYETHYLENE GLYCOL 400) LIQUID [KAREWAY PRODUCT, INC.] 1 POLYETHYLENE GLYCOL 400 ACTIVE INGREDIENT B697894SGQ TEARS LUBRICANT (GLYCERIN, HYPROMELLOSES, POLYETHYLENE GLYCOL 400) LIQUID [KAREWAY PRODUCT, INC.] 1 GLYCERIN ACTIVE MOIETY PDC6A3C0OX TEARS LUBRICANT (GLYCERIN, HYPROMELLOSES, POLYETHYLENE GLYCOL 400) LIQUID [KAREWAY PRODUCT, INC.] 1 HYPROMELLOSES ACTIVE MOIETY 3NXW29V3WO TEARS LUBRICANT (GLYCERIN, HYPROMELLOSES, POLYETHYLENE GLYCOL 400) LIQUID [KAREWAY PRODUCT, INC.] 1 POLYETHYLENE GLYCOL 400 ACTIVE MOIETY B697894SGQ TEARS LUBRICANT (GLYCERIN, HYPROMELLOSES, POLYETHYLENE GLYCOL 400) LIQUID [KAREWAY PRODUCT, INC.] 1 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R TEARS LUBRICANT (GLYCERIN, HYPROMELLOSES, POLYETHYLENE GLYCOL 400) LIQUID [KAREWAY PRODUCT, INC.] 1 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 TEARS LUBRICANT (GLYCERIN, HYPROMELLOSES, POLYETHYLENE GLYCOL 400) LIQUID [KAREWAY PRODUCT, INC.] 1 BORIC ACID INACTIVE INGREDIENT R57ZHV85D4 TEARS LUBRICANT (GLYCERIN, HYPROMELLOSES, POLYETHYLENE GLYCOL 400) LIQUID [KAREWAY PRODUCT, INC.] 1 DEXTROSE INACTIVE INGREDIENT IY9XDZ35W2 TEARS LUBRICANT (GLYCERIN, HYPROMELLOSES, POLYETHYLENE GLYCOL 400) LIQUID [KAREWAY PRODUCT, INC.] 1 MAGNESIUM CHLORIDE INACTIVE INGREDIENT 02F3473H9O TEARS LUBRICANT (GLYCERIN, HYPROMELLOSES, POLYETHYLENE GLYCOL 400) LIQUID [KAREWAY PRODUCT, INC.] 1 POTASSIUM CHLORIDE INACTIVE INGREDIENT 660YQ98I10 TEARS LUBRICANT (GLYCERIN, HYPROMELLOSES, POLYETHYLENE GLYCOL 400) LIQUID [KAREWAY PRODUCT, INC.] 1 SODIUM BORATE INACTIVE INGREDIENT 91MBZ8H3QO TEARS LUBRICANT (GLYCERIN, HYPROMELLOSES, POLYETHYLENE GLYCOL 400) LIQUID [KAREWAY PRODUCT, INC.] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR TEARS LUBRICANT (GLYCERIN, HYPROMELLOSES, POLYETHYLENE GLYCOL 400) LIQUID [KAREWAY PRODUCT, INC.] 1 SODIUM LACTATE INACTIVE INGREDIENT TU7HW0W0QT TEARS LUBRICANT (GLYCERIN, HYPROMELLOSES, POLYETHYLENE GLYCOL 400) LIQUID [KAREWAY PRODUCT, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R TEARS LUBRICANT (GLYCERIN, HYPROMELLOSES, POLYETHYLENE GLYCOL 400) LIQUID [KAREWAY PRODUCT, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67510-0063 TEARS LUBRICANT (GLYCERIN, HYPROMELLOSES, POLYETHYLENE GLYCOL 400) LIQUID [KAREWAY PRODUCT, INC.] 3 Legacy NDC, 2 package rows 20191029_d98abe91-1967-4a07-9730-e98766912d68.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 67510-0063-5 67510006305 1 BOTTLE in 1 BOX (67510-0063-5) > 15 mL in 1 BOTTLE 1 bottle 2018-05-30 0000-00-00 No No Current