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
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 0121-0775 | 0121-0775-08 | D | Discontinued by firm | 2026-10-16 |
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.
| 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 |
|---|---|
| GUAIFENESIN | 100 mg/5mL |
| CODEINE PHOSPHATE | 10 mg/5mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 495W7451VQ | Internal UNII lookup |
| GSL05Y1MN6 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 995868 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 88d0994c-4270-4408-8837-bd97510b2118 | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 0121-0775-04 | 2022-03-28 | Guaifenesin and Codeine Phosphate |
| 0121-0775-08 | 2022-03-28 | Guaifenesin and Codeine Phosphate |
| 0121-0775-16 | 2022-03-28 | Guaifenesin and Codeine Phosphate |
| 0121-0775-04 | 2022-01-28 | Guaifenesin and Codeine Phosphate |
| 0121-0775-08 | 2022-01-28 | Guaifenesin and Codeine Phosphate |
| 0121-0775-16 | 2022-01-28 | Guaifenesin and Codeine Phosphate |
DailyMed Package Descriptions#
| 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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0121-0775-04 | ML - Milliliter | 0121-0775 | ac9f8c15-4f02-4667-b975-5c20f7d93dab | 1 | 2012-07-24 |
| 0121-0775-08 | ML - Milliliter | 0121-0775 | ef3933a2-ccb0-4b44-977e-b6b8f9f14e12 | 1 | 2018-02-20 |
| 0121-0775-16 | ML - Milliliter | 0121-0775 | 270b5b4b-ceb0-4155-ad98-6b3454cf2a29 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Sinus PE Head Congestion and Mucus | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Better Living Brands, LLC | 28a4ec37-11dd-4134-81aa-851f081bf088 | 2026-08-17 | Warnings | M012 |
| CVS Health No Drip | NASAL MIST | CVS PHARMACY,INC. | 60ee7bd2-0d7c-4228-a559-0d5dbd3d44fa | 2026-08-17 | Warnings | M012 |
| Daytime Cold and Cough and NightTime Cold and Congestion Childrens | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Walgreens | 2bdc62b6-f3e1-4a79-9b29-00cc1d4280b3 | 2026-08-17 | Warnings | M012 |
| CVS Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL | CVS HEALTH | f01ab8ef-d29a-4e33-8a14-4c57ccdcc0d6 | 2026-08-17 | Warnings | M012 |
| Daytime Nighttime | ACETAMINOPHEN, GUAIFENESIN, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL | KROGER COMPANY | 30d50bbe-0a14-c985-e063-6294a90a47b3 | 2026-08-16 | Warnings | M012 |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | ARMY AND AIR FORCE EXCHANGE SERVICE | 77f87e19-a9d5-479d-9434-bbde13210bfb | 2026-08-15 | Warnings | M012 |
| Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Cardinal Health 110, LLC. DBA Leader | b1c2055b-4b5a-4fa2-b600-8930c9c8524c | 2026-08-15 | Warnings | M012 |
| Nighttime HBP Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | CVS PHARMACY | 146c9a62-0418-4b5d-9074-5be8a05f3f93 | 2026-08-15 | Warnings | M012 |
| Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Cardinal Health 110, LLC. DBA Leader | 610accad-2f8b-4605-9357-a58e6e18d417 | 2026-08-15 | Warnings | M012 |
| Nasal Decongestant Maximum Strength, Non-Drowsy | PSEUDOEPHEDRINE HCL | Amerisource Bergen | 1fdb1ba5-4072-4baf-9e30-f01d57bf6d82 | 2026-08-15 | Warnings | M012 |
| Cold and Flu Night | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Walgreen Company | 32c67914-d7cf-40ee-8682-0ba8ed691287 | 2026-08-15 | Warnings | M012 |
| CVS Childrens COLD PLUS COUGH PLUS SORE THROAT | ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE | CVS PHARMACY | 27820bce-6638-4f17-ac66-62b02b76bec3 | 2026-08-14 | Warnings | M012 |
| CVS PHARMACY Childrens Cold and Allergy | BROMPHENIRAMINE MALEATE | CVS PHARMACY, INC. | 004e104b-d6ff-48d5-8685-cd1bff45399a | 2026-08-14 | Warnings | M012 |
| CHILDRENS DIMETAPP COLD AND COUGH | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | CVS PHARMACY | 7babf4f6-ca0a-44a7-b1ea-d60e20d36f15 | 2026-08-14 | Warnings | M012 |
| Nasal | OXYMETAZOLINE HYDROCHLORIDE | Amazon.com Services LLC | e7c8ffed-83b8-4088-b72c-d937e93f8b54 | 2026-08-14 | Warnings | M012 |
| CVS Mucus Relief DM and Overnight Cold and Flu | DEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN AND TRIPROLIDINE HCL | CVS | 75520b77-d40b-4f43-b92a-7a3eba5b493f | 2026-08-14 | Warnings | M012 |
| CVS Severe Multi-Symptom Cough Cold Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | CVS PHARMACY | bb24c298-1d00-4378-8de3-b4056220fa75 | 2026-08-14 | Warnings | M012 |
| SEVERE COLD PLUS FLU DAYTIME NIGHTTIME | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE | CVS Pharmacy,Inc. | 6cb1d08b-e544-4084-b9ed-1e0d99a709c8 | 2026-08-14 | Warnings, Adverse reactions | M012 |
| Theraflu Relief Max Strength Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | CVS PHARMACY | 932a3d40-9b52-4e91-bc61-6fd506f2d9e6 | 2026-08-14 | Warnings | M012 |
| Multi Symptom Severe Cold and Nighttime Severe Cold and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | CVS Pharmacy,Inc. | 91063edd-1e7e-41e9-8412-b14ef3749018 | 2026-08-14 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 995868 | codeine phosphate 10 MG / guaiFENesin 100 MG in 5 mL Oral Solution | PSN | 88d0994c-4270-4408-8837-bd97510b2118 | 11 |
| 995868 | codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral Solution | SCD | 88d0994c-4270-4408-8837-bd97510b2118 | 11 |
| 995868 | codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral Solution | SY | 88d0994c-4270-4408-8837-bd97510b2118 | 11 |
| 995868 | codeine phosphate 10 MG / guaiFENesin 100 MG in 5 mL Oral Solution | PSN | 36140639-e7a8-43bc-83e2-469430af9d1a | 9 |
| 995868 | codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral Solution | SCD | 36140639-e7a8-43bc-83e2-469430af9d1a | 9 |
| 995868 | codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral Solution | SY | 36140639-e7a8-43bc-83e2-469430af9d1a | 9 |
| 995868 | codeine phosphate 10 MG / guaiFENesin 100 MG in 5 mL Oral Solution | PSN | f5265ae5-db8e-428d-90e9-5eda6a8a22bd | 3 |
| 995868 | codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral Solution | SCD | f5265ae5-db8e-428d-90e9-5eda6a8a22bd | 3 |
| 995868 | codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral Solution | SY | f5265ae5-db8e-428d-90e9-5eda6a8a22bd | 3 |
| 995868 | codeine phosphate 10 MG / guaiFENesin 100 MG in 5 mL Oral Solution | PSN | 91e9e5e2-5178-4476-9333-02c27bfc4f70 | 1 |
| 995868 | codeine phosphate 10 MG / guaiFENesin 100 MG in 5 mL Oral Solution | PSN | 9f130e16-c588-43be-bb19-e30d2268e527 | 1 |
| 995868 | codeine phosphate 10 MG / guaiFENesin 100 MG in 5 mL Oral Solution | PSN | f27dcda2-e7a2-469a-9649-12c065cb7459 | 1 |
| 995868 | codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral Solution | SCD | 91e9e5e2-5178-4476-9333-02c27bfc4f70 | 1 |
| 995868 | codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral Solution | SCD | 9f130e16-c588-43be-bb19-e30d2268e527 | 1 |
| 995868 | codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral Solution | SCD | f27dcda2-e7a2-469a-9649-12c065cb7459 | 1 |
| 995868 | codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral Solution | SY | 9f130e16-c588-43be-bb19-e30d2268e527 | 1 |
| 995868 | codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral Solution | SY | f27dcda2-e7a2-469a-9649-12c065cb7459 | 1 |
| 995868 | codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral Solution | SY | 91e9e5e2-5178-4476-9333-02c27bfc4f70 | 1 |
Packages#
| 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 |