Home NDC 68071-5173-4 Codeine-Guaifenesin
Product NDC 68071-5173
Requested package NDC 68071-5173-4
11-digit product format 680715173
Labeler code 68071
Product ID 68071-5173_1b56a7bc-e859-d8c7-e063-6294a90a5ee1
Type HUMAN OTC DRUG
Nonproprietary name Codeine Phosphate and Guaifenesin
Dosage form SOLUTION
Route ORAL
Labeler NuCare Pharmaceuticals,Inc.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-04-01
Substance CODEINE PHOSPHATE; GUAIFENESIN
Active strength 10; 100 mg/5mL; mg/5mL
Pharmacologic classes Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Full Opioid Agonists [MoA], Increased Respiratory Secretions [PE], Opioid Agonist [EPC]
DEA schedule CV
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 3 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 2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 68071-5173 68071-5173-4 I Inactivated by FDA excluded / ndc_excluded.zip 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 68071-5173 68071-5173-4 I Inactivated by FDA excluded / ndc_excluded.zip 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 68071-5173 68071-5173-4 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Codeine-Guaifenesin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CODEINE PHOSPHATE 10 mg/5mL GUAIFENESIN 100 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination GSL05Y1MN6 Internal UNII lookup 495W7451VQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 995868 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 68071-5173-4 Codeine-Guaifenesin 120 mL in 1 BOTTLE SOLUTION 120 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-5173 CODEINE-GUAIFENESIN (CODEINE PHOSPHATE AND GUAIFENESIN) SOLUTION [NUCARE PHARMACEUTICALS,INC.] 3 Current NDC, Legacy NDC, 1 package rows 20240627_9e691264-d48a-6b48-e053-2995a90a9352.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 83 · 1,657 matching rows.
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 68071-5173-4 68071517304 120 mL in 1 BOTTLE (68071-5173-4) 120 ml 2020-02-12 0000-00-00 No No Current