Home NDC 68071-5173 Codeine-Guaifenesin
Product NDC 68071-5173
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 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 68071-5173-4 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 68071-5173-4 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 68071-5173-4 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 2 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join MAX relief junior ACETAMINOPHEN Akron Pharma Inc. 0e43b885-3843-4f11-9a53-02a38c228313 2026-08-31 Warnings Exact identifier application number: M013 MAX relief junior CHILDREN ACETAMINOPHEN Akron Pharma Inc. d7874e4d-0b38-4bb1-9a62-aa4f66d9baf9 2026-08-31 Warnings Exact identifier application number: M013 MAX relief junior Grape CHILDREN ACETAMINOPHEN Akron Pharma Inc. 3c7a7f40-4963-4fd1-942e-93fa08a45830 2026-08-31 Warnings Exact identifier application number: M013 Genexa Kids Pain and Fever ACETAMINOPHEN Genexa Inc. 5a615118-33c9-1520-e063-6394a90a21a6 2026-08-31 Warnings Exact identifier application number: M013 acetaminophen extra strength ACETAMINOPHEN Sam's West Inc dd99efd0-4ca4-4dc6-a940-bebd17ac8f8d 2026-08-28 Warnings Exact identifier application number: M013 Aspirin 81 mg ASPIRIN HAWAII REPACK, INC. ac94cce3-9a39-41de-bb8b-10a5e5b8e83b 2026-08-28 Warnings Exact identifier application number: M013 Aspirin ASPIRIN WinCo Foods, LLC a0a19cd1-eb8a-4773-be00-78de90d2a3c3 2026-08-28 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN FSA STORE INC. 5502ef15-9f40-db56-e063-6394a90a2de4 2026-08-26 Warnings Exact identifier application number: M013 Dye Free Pain and Fever Childrens ACETAMINOPHEN Walgreens 3ea217dd-e5b9-4d4b-861a-76ce61ba3a1d 2026-08-26 Warnings Exact identifier application number: M013 HyVee Extra Strength Headache Relief CAPLET ACETAMINOPHEN, ASPIRIN, CAFFEINE HyVee Inc 495c75bf-c09a-accd-e063-6294a90a75ec 2026-08-24 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Walgreens 543f93d1-df14-0bd2-e063-6294a90a4413 2026-08-24 Warnings Exact identifier application number: M013 ACETAMINOPHEN ACETAMINOPHEN Akron Pharma Inc. ab79fd60-8315-4c63-8045-1b0511ac268f 2026-08-24 Warnings Exact identifier application number: M013 Genexa Infants Pain and Fever ACETAMINOPHEN Genexa Inc. 4fd048c3-70bc-2ea7-e063-6394a90a55f2 2026-08-22 Warnings Exact identifier application number: M013 Genexa Kids Pain and Fever ACETAMINOPHEN Genexa Inc. 59adabeb-97e8-2de4-e063-6394a90acc47 2026-08-22 Warnings Exact identifier application number: M013 Headache Relief ACETAMINOPHEN, ASPIRIN, CAFFEINE Publix Super Markets Inc a876daa7-ade3-497d-87bb-46d6e4dc185a 2026-08-21 Warnings Exact identifier application number: M013 equate aspirin ASPIRIN Wal-Mart Stores Inc ea3f8eed-7b70-4156-9586-125d27bf29a8 2026-08-19 Warnings Exact identifier application number: M013 aspirin chewable, low dose ASPIRIN United Natural Foods, Inc. dba UNFI 6a6ac7fe-91a4-4b55-979a-b53b51505d8b 2026-08-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Sam's West Inc 1098d0e7-8202-4018-a2d2-b0c80ee58b56 2026-08-19 Warnings Exact identifier application number: M013 Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN, CAFFEINE Safeway, Inc. 5e77dca4-2ff8-4a8c-94bd-f224b680ca23 2026-08-19 Warnings Exact identifier application number: M013 dg health pain relief pm extra strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL Dolgencorp Inc 4d1eddf0-eff7-4c47-b312-30dee08d9e5f 2026-08-19 Warnings Exact identifier application number: M013
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