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 75 of 178 · 3,550 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mixed Berry Sore Throat and Cough Lozenges BENZOCAINE HEB 3063ea93-6bc2-1d18-e054-00144ff88e88 2025-12-13 Warnings Exact identifier application number: M012 HEB Menthol Cough Drops MENTHOL HEB c197855d-15b4-38fc-e053-2a95a90a2dc7 2025-12-13 Warnings Exact identifier application number: M012 HEB SF Honey Lemon Cough Drops MENTHOL HEB d09ed4bb-7595-5e54-e053-2a95a90aa109 2025-12-13 Warnings Exact identifier application number: M012 HEB Cherry Cough Drops MENTHOL HEB c198e3c7-5ba7-ece6-e053-2995a90adb38 2025-12-13 Warnings Exact identifier application number: M012 HEB Honey Lemon Cough Drops MENTHOL HEB c19a79bc-9872-2e87-e053-2a95a90a9427 2025-12-13 Warnings Exact identifier application number: M012 Cold and Flu Daytime Nighttime ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL WALMART INC. 26f55169-4b37-4a36-88ee-064d6e962065 2025-12-12 Warnings Exact identifier application number: M012 Allergy Relief DIPHENHYDRAMINE HCL Walgreen Company 39ce76a3-b7a8-43be-9b61-5c1446cd9e90 2025-12-12 Warnings Exact identifier application number: M012 Cold and Flu maximum strength ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL Rite Aid Corporation ac01206f-a717-4c0b-8a03-fab0a4fd154b 2025-12-12 Warnings Exact identifier application number: M012 Sinus Severe ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL Strategic Sourcing Services LLC dcb80dd5-465d-4792-947a-3044e25a5284 2025-12-12 Warnings Exact identifier application number: M012 Vapor Rub COUGH SUPPRESSANT Neilmed Pharmaceuticals Inc. 39190f9f-8a5a-e4d8-e063-6294a90a57dd 2025-12-12 Warnings Exact identifier application number: M012 Allergy Relief, 24-7 Life by 7-Eleven DIPHENHYDRAMINE HCL TABLET, FILM COATED Lil' Drug Store Products, Inc. 45c4cd6c-327d-5950-e063-6394a90a3a21 2025-12-12 Warnings Exact identifier application number: M012 Menthol cough drops MENTHOL Family Dollar 44bb3b95-b2ba-470e-e054-00144ff88e88 2025-12-12 Warnings Exact identifier application number: M012 menthol cough drops MENTHOL Family Dollar 44bb9c7b-994b-4ab8-e054-00144ff8d46c 2025-12-12 Warnings Exact identifier application number: M012 cherry cough drops MENTHOL Family Dollar 44be9837-f15a-09f2-e054-00144ff8d46c 2025-12-12 Warnings Exact identifier application number: M012 cherry cough drops MENTHOL Family Dollar 44bcae39-2389-09ee-e054-00144ff8d46c 2025-12-12 Warnings Exact identifier application number: M012 honey lemon cough drops MENTHOL Family Dollar 46635813-66c4-504c-e054-00144ff8d46c 2025-12-12 Warnings Exact identifier application number: M012 honey lemon cough drops MENTHOL Family Dollar 455b0f4b-0526-2361-e054-00144ff8d46c 2025-12-12 Warnings Exact identifier application number: M012 Family Wellness Strawberry Cough Drops MENTHOL Family Dollar f92466ac-dd93-9ac5-e053-6294a90a9291 2025-12-12 Warnings Exact identifier application number: M012 GoodSense Menthol Cough Drops MENTHOL Geiss, Destin, Dunn c6b25d69-8930-6867-e053-2a95a90ad208 2025-12-12 Warnings Exact identifier application number: M012 Good Sense Cherry Cough Drops MENTHOL Geiss, Destin, Dunn c72db7f0-9324-8ed2-e053-2995a90a9868 2025-12-12 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