Home NDC 0121-0775 Guaifenesin and Codeine Phosphate
Product NDC 0121-0775
11-digit product format 001210775
Labeler code 0121
Product ID 0121-0775_2175415b-f07e-50a6-e063-6394a90acabe
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin and Codeine Phosphate
Dosage form SOLUTION
Route ORAL
Labeler PAI Holdings, LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2006-10-01
Substance GUAIFENESIN; CODEINE PHOSPHATE
Active strength 100; 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 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 · 11 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…
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 Guaifenesin and Codeine Phosphate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 100 mg/5mL CODEINE PHOSPHATE 10 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 0121-0775-04 Guaifenesin and Codeine Phosphate 118 mL in 1 BOTTLE SOLUTION 118 11 0121-0775-08 Guaifenesin and Codeine Phosphate 237 mL in 1 BOTTLE SOLUTION 237 11 0121-0775-16 Guaifenesin and Codeine Phosphate 473 mL in 1 BOTTLE SOLUTION 473 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Codeine Phosphate ACTIVE INGREDIENT GSL05Y1MN6 GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DIRECTRX] 1 Codeine Phosphate ACTIVE INGREDIENT GSL05Y1MN6 GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [A-S MEDICATION SOLUTIONS LLC] 1 CODEINE PHOSPHATE ACTIVE INGREDIENT GSL05Y1MN6 GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.] 1 Codeine Phosphate ACTIVE INGREDIENT GSL05Y1MN6 GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [PROFICIENT RX LP] 1 Codeine Phosphate ACTIVE INGREDIENT GSL05Y1MN6 GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 1 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.] 1 Guaifenesin ACTIVE INGREDIENT 495W7451VQ GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [A-S MEDICATION SOLUTIONS LLC] 1 Guaifenesin ACTIVE INGREDIENT 495W7451VQ GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DIRECTRX] 1 Guaifenesin ACTIVE INGREDIENT 495W7451VQ GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [PROFICIENT RX LP] 1 Guaifenesin ACTIVE INGREDIENT 495W7451VQ GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 1 Codeine ACTIVE MOIETY Q830PW7520 GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 1 CODEINE ANHYDROUS ACTIVE MOIETY UX6OWY2V7J GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [PROFICIENT RX LP] 1 CODEINE ANHYDROUS ACTIVE MOIETY UX6OWY2V7J GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.] 1 CODEINE ANHYDROUS ACTIVE MOIETY UX6OWY2V7J GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [A-S MEDICATION SOLUTIONS LLC] 1 CODEINE ANHYDROUS ACTIVE MOIETY UX6OWY2V7J GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DIRECTRX] 1 Guaifenesin ACTIVE MOIETY 495W7451VQ GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 1 Guaifenesin ACTIVE MOIETY 495W7451VQ GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [A-S MEDICATION SOLUTIONS LLC] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DIRECTRX] 1 Guaifenesin ACTIVE MOIETY 495W7451VQ GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [PROFICIENT RX LP] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.] 1 CITRIC ACID ACETATE INACTIVE INGREDIENT DSO12WL7AU GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [PROFICIENT RX LP] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.] 1 edetate disodium INACTIVE INGREDIENT 7FLD91C86K GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DIRECTRX] 1 edetate disodium INACTIVE INGREDIENT 7FLD91C86K GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.] 1 FD&C Blue No. 1 INACTIVE INGREDIENT H3R47K3TBD GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DIRECTRX] 1 FD&C Blue No. 1 INACTIVE INGREDIENT H3R47K3TBD GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.] 1 FD&C Red No. 40 INACTIVE INGREDIENT WZB9127XOA GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DIRECTRX] 1 FD&C Red No. 40 INACTIVE INGREDIENT WZB9127XOA GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [A-S MEDICATION SOLUTIONS LLC] 1 FD&C Yellow No. 6 INACTIVE INGREDIENT H77VEI93A8 GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.] 1 FD&C Yellow No. 6 INACTIVE INGREDIENT H77VEI93A8 GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DIRECTRX] 1 glycerin INACTIVE INGREDIENT PDC6A3C0OX GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.] 1 menthol INACTIVE INGREDIENT L7T10EIP3A GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DIRECTRX] 1 menthol INACTIVE INGREDIENT L7T10EIP3A GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.] 1 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DIRECTRX] 1 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.] 1 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.] 1 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DIRECTRX] 1 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.] 1 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DIRECTRX] 1 sorbitol INACTIVE INGREDIENT 506T60A25R GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.] 1 sorbitol INACTIVE INGREDIENT 506T60A25R GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DIRECTRX] 1 WATER INACTIVE INGREDIENT 059QF0KO0R GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0121-0775 GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [PAI HOLDINGS, LLC] 11 Current NDC, Legacy NDC, 3 package rows 20240907_88d0994c-4270-4408-8837-bd97510b2118.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 71 of 178 · 3,550 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Good Sense Nasal Decongestant PSEUDOEPHEDRINE HCL L. Perrigo Company 455b35b4-3969-411b-8036-887615d71e11 2025-12-21 Warnings Exact identifier application number: M012 Menthol Cough Drop MENTHOL Safeway Inc. 4a4f7f82-1b6c-7082-e054-00144ff88e88 2025-12-20 Warnings Exact identifier application number: M012 Cherry Cough Drop MENTHOL Safeway Inc. 4a52c0c2-8659-2819-e054-00144ff8d46c 2025-12-20 Warnings Exact identifier application number: M012 Signature Care Cherry Cough Drops MENTHOL Safeway a733e905-af15-d3ea-e053-2a95a90aa7c3 2025-12-20 Warnings Exact identifier application number: M012 Signature Care Honey Lemon Cough Drops MENTHOL Safeway a742449f-c76b-2b91-e053-2a95a90ae4d2 2025-12-20 Warnings Exact identifier application number: M012 Cherry Sore Throat Lozenge BENZOCAINE TopCo 60b876e7-c642-5ce8-e053-2a91aa0abd6e 2025-12-20 Warnings Exact identifier application number: M012 menthol cough drops MENTHOL Topco Associates 366cc6b1-beff-29d2-e054-00144ff88e88 2025-12-20 Warnings Exact identifier application number: M012 cherry cough drops MENTHOL TopCo Associates 3fef2117-7311-1e66-e054-00144ff8d46c 2025-12-20 Warnings Exact identifier application number: M012 honey lemon cough drops MENTHOL Topco Associates 3ff1bf05-e407-3b67-e054-00144ff8d46c 2025-12-20 Warnings Exact identifier application number: M012 sugar free menthol cough drops MENTHOL Topco Associates 36727f0c-d6d2-28a3-e054-00144ff8d46c 2025-12-20 Warnings Exact identifier application number: M012 sugar free honey lemon cough drops MENTHOL Topco Associates 36824bee-607e-7095-e054-00144ff8d46c 2025-12-20 Warnings Exact identifier application number: M012 Mixed Berry Sore Throat Lozenges BENZOCAINE Topco Associates 7a00c771-9231-e877-e053-2a91aa0ac96e 2025-12-20 Warnings Exact identifier application number: M012 MUCUS RELIEF GUAIFENESIN 400 MG NUVICARE LLC e25b440e-f389-443f-b333-c66ad1747158 2025-12-19 Warnings Exact identifier application number: M012 Cold and Flu severe ACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL Wal-Mart Stores Inc 9fca25dc-f63e-487a-8b7c-84d65ea51cb5 2025-12-19 Warnings Exact identifier application number: M012 Cold and Flu Severe ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL Geiss, Destin & Dunn Inc. a7d2eaee-484e-43aa-8ae3-0e050219383f 2025-12-19 Warnings Exact identifier application number: M012 Cherry Cough Drops MENTHOL Publix 66d8e5f7-9766-57f3-e053-2991aa0a7e17 2025-12-19 Warnings Exact identifier application number: M012 Honey Lemon Cough Drops MENTHOL Publix 66e89fa3-ee09-1d16-e053-2a91aa0ae17c 2025-12-19 Warnings Exact identifier application number: M012 Poly-Vent DM DEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCL Poly Pharmaceuticals, Inc. 739329ae-0b62-4eab-a07d-867b5d3d61e0 2025-12-19 Warnings Exact identifier application number: M012 Chest Congestion and Cough Relief DM DEXTROMETHORPHAN HBR, GUAIFENESIN ARMY AND AIR FORCE EXCHANGE SERVICE 89494a7c-cdbf-48f1-aaa9-2e57d4388a68 2025-12-19 Warnings Exact identifier application number: M012 DayTime Cold/Flu Relief ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL ARMY AND AIR FORCE EXCHANGE SERVICE 04f9134e-1311-4843-90db-9244b9e61e1d 2025-12-19 Warnings Exact identifier application number: M012
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 0121-0775-04 00121077504 118 mL in 1 BOTTLE (0121-0775-04) 118 ml 2006-10-01 0000-00-00 No No Current 0121-0775-08 00121077508 237 mL in 1 BOTTLE (0121-0775-08) 237 ml 2006-10-01 0000-00-00 No No Current 0121-0775-16 00121077516 473 mL in 1 BOTTLE (0121-0775-16) 473 ml 2006-10-01 0000-00-00 No No Current