Home NDC 70752-180-12 GUAIFENESIN and CODEINE PHOSPHATE
Product NDC 70752-180
Requested package NDC 70752-180-12
11-digit product format 707520180
Labeler code 70752
Product ID 70752-180_09ec7e5f-a353-494b-981d-597276be1d4f
Type HUMAN OTC DRUG
Nonproprietary name GUAIFENESIN and CODEINE PHOSPHATE
Dosage form SOLUTION
Route ORAL
Labeler QUAGEN PHARMACEUTICALS LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2022-05-23
Marketing end 0000-00-00
Substance CODEINE PHOSPHATE; GUAIFENESIN
Active strength 10 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 2023-12-31
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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 70752-180-06 2025-06-24 Guaifenesin and Codeine Phosphate Oral Solution, USP CV 100 mg/10 mg per 5 mL SUGAR FREE, DYE FREE, ALCOHOL FREE 70752-180-12 2025-06-24 Guaifenesin and Codeine Phosphate Oral Solution, USP CV 100 mg/10 mg per 5 mL SUGAR FREE, DYE FREE, ALCOHOL FREE 70752-180-15 2025-06-24 Guaifenesin and Codeine Phosphate Oral Solution, USP CV 100 mg/10 mg per 5 mL SUGAR FREE, DYE FREE, ALCOHOL FREE 70752-180-06 2025-01-30 Guaifenesin and Codeine Phosphate Oral Solution, USP CV 100 mg/10 mg per 5 mL SUGAR FREE, DYE FREE, ALCOHOL FREE 70752-180-12 2025-01-30 Guaifenesin and Codeine Phosphate Oral Solution, USP CV 100 mg/10 mg per 5 mL SUGAR FREE, DYE FREE, ALCOHOL FREE 70752-180-15 2025-01-30 Guaifenesin and Codeine Phosphate Oral Solution, USP CV 100 mg/10 mg per 5 mL SUGAR FREE, DYE FREE, ALCOHOL FREE
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70752-180 GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [QUAGEN PHARMACEUTICALS LLC] 2 Legacy NDC 20220705_c166f149-b130-4e18-842f-d4d0a2988830.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 70752-180-12 70752018012 473 mL in 1 BOTTLE (70752-180-12) 473 ml 2022-05-23 0000-00-00 No No Current