Home NDC 49869-002 Avitears
Product NDC 49869-002
11-digit product format 498690002
Labeler code 49869
Product ID 49869-002_a238b922-010a-40fb-8ee8-da3a82c376c4
Type HUMAN OTC DRUG
Nonproprietary name polysorbate 80
Dosage form SOLUTION/ DROPS
Route TOPICAL
Labeler Pinnacle Science, LLc
Application part349
Marketing category OTC MONOGRAPH FINAL
Marketing start 2009-07-17
Marketing end 0000-00-00
Substance POLYSORBATE 80
Active strength 10 mg/mL
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record NDC auxiliary status# Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date excluded product product 49869-002 I Inactivated by FDA 2026-07-31 excluded package package 49869-002 49869-002-01 I Inactivated by FDA 2026-07-31 excluded package package 49869-002 49869-002-02 I Inactivated by FDA 2026-07-31
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children, if swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49869-002-01 Avitears 15 mL in 1 BOTTLE, PLASTIC SOLUTION/ DROPS 15 1 49869-002-02 Avitears 10 mL in 1 BOTTLE, PLASTIC SOLUTION/ DROPS 10 1
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49869-002 AVITEARS (POLYSORBATE 80) SOLUTION/ DROPS [PINNACLE SCIENCE, LLC] 1 Legacy NDC, 2 package rows 20091117_dbb0d312-c79a-4c89-acb1-b895b52c05d5.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 49869-002-01 49869000201 15 mL in 1 BOTTLE, PLASTIC 15 ml Historical 49869-002-02 49869000202 10 mL in 1 BOTTLE, PLASTIC 10 ml Historical