Home NDC 16571-301 Guaifenesin DAC
Product NDC 16571-301
11-digit product format 165710301
Labeler code 16571
Product ID 16571-301_08a574fb-ce43-4859-a5cf-6f62bd0ca09e
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin, Codeine Phosphate and Pseudoephedrine Hydrochloride
Dosage form LIQUID
Route ORAL
Labeler Rising Pharmaceuticals
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2016-02-01
Marketing end 0000-00-00
Substance GUAIFENESIN; CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength 100 mg/5mL; mg/5mL; mg/5mL
DEA schedule CV
NDC exclude flag No
Listing certified through 2019-12-31
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 · 26 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 16571-301-16 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 16571-301-16 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 16571-301-16 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 16571-301-16 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 16571-301-16 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 16571-301-16 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 16571-301-16 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 16571-301-16 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 16571-301-16 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 16571-301-16 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 16571-301-16 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 16571-301-16 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 16571-301-16 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Codeine Phosphate ACTIVE INGREDIENT GSL05Y1MN6 GUAIFENESIN DAC (GUAIFENESIN, CODEINE PHOSPHATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [PACK PHARMACEUTICALS LLC] 1 Guaifenesin ACTIVE INGREDIENT 495W7451VQ GUAIFENESIN DAC (GUAIFENESIN, CODEINE PHOSPHATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [PACK PHARMACEUTICALS LLC] 1 Pseudoephedrine Hydrochloride ACTIVE INGREDIENT 6V9V2RYJ8N GUAIFENESIN DAC (GUAIFENESIN, CODEINE PHOSPHATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [PACK PHARMACEUTICALS LLC] 1 Codeine ACTIVE MOIETY Q830PW7520 GUAIFENESIN DAC (GUAIFENESIN, CODEINE PHOSPHATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [PACK PHARMACEUTICALS LLC] 1 Guaifenesin ACTIVE MOIETY 495W7451VQ GUAIFENESIN DAC (GUAIFENESIN, CODEINE PHOSPHATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [PACK PHARMACEUTICALS LLC] 1 Pseudoephedrine ACTIVE MOIETY 7CUC9DDI9F GUAIFENESIN DAC (GUAIFENESIN, CODEINE PHOSPHATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [PACK PHARMACEUTICALS LLC] 1 Alcohol INACTIVE INGREDIENT 3K9958V90M GUAIFENESIN DAC (GUAIFENESIN, CODEINE PHOSPHATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [PACK PHARMACEUTICALS LLC] 1 Caramel INACTIVE INGREDIENT T9D99G2B1R GUAIFENESIN DAC (GUAIFENESIN, CODEINE PHOSPHATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [PACK PHARMACEUTICALS LLC] 1 Citric Acid Monohydrate INACTIVE INGREDIENT 2968PHW8QP GUAIFENESIN DAC (GUAIFENESIN, CODEINE PHOSPHATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [PACK PHARMACEUTICALS LLC] 1 Edetate Disodium INACTIVE INGREDIENT 7FLD91C86K GUAIFENESIN DAC (GUAIFENESIN, CODEINE PHOSPHATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [PACK PHARMACEUTICALS LLC] 1 FD&C Red no. 40 INACTIVE INGREDIENT WZB9127XOA GUAIFENESIN DAC (GUAIFENESIN, CODEINE PHOSPHATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [PACK PHARMACEUTICALS LLC] 1 Glycerin INACTIVE INGREDIENT PDC6A3C0OX GUAIFENESIN DAC (GUAIFENESIN, CODEINE PHOSPHATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [PACK PHARMACEUTICALS LLC] 1 Menthol INACTIVE INGREDIENT L7T10EIP3A GUAIFENESIN DAC (GUAIFENESIN, CODEINE PHOSPHATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [PACK PHARMACEUTICALS LLC] 1 Saccharin Sodium INACTIVE INGREDIENT SB8ZUX40TY GUAIFENESIN DAC (GUAIFENESIN, CODEINE PHOSPHATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [PACK PHARMACEUTICALS LLC] 1 Sodium Benzoate INACTIVE INGREDIENT OJ245FE5EU GUAIFENESIN DAC (GUAIFENESIN, CODEINE PHOSPHATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [PACK PHARMACEUTICALS LLC] 1 Sorbitol INACTIVE INGREDIENT 506T60A25R GUAIFENESIN DAC (GUAIFENESIN, CODEINE PHOSPHATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [PACK PHARMACEUTICALS LLC] 1 Water INACTIVE INGREDIENT 059QF0KO0R GUAIFENESIN DAC (GUAIFENESIN, CODEINE PHOSPHATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [PACK PHARMACEUTICALS LLC] 1