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 | 2026-10-20 |
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 |
|---|---|---|---|---|---|---|
| Childrens Mucus Cough and Congestion Relief | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | 8b5d391b-6c23-44c3-81d0-c08822bf6d01 | 2026-05-18 | Warnings | M012 |
| Mucinex Childrens Night Time Multi-Symptom Cold | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | e048cd53-a3cd-484f-a972-4cb49791dba3 | 2026-05-18 | Warnings | M012 |
| Mucinex Childrens Cough | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Reckitt Benckiser LLC | b8132c81-5291-431a-ad3a-ec8a3eb21c19 | 2026-05-18 | Warnings | M012 |
| Mucinex Childrens Stuffy Nose and Chest Congestion | GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 7354f57c-0ecf-481f-9482-0040c90c4350 | 2026-05-18 | Warnings | M012 |
| Mucinex Childrens Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 5bda415d-739f-4ca5-b5b2-07c14a81863b | 2026-05-18 | Warnings | M012 |
| Mucinex Childrens Multi-Symptom Cold and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 8f3eb5c5-832e-4806-b3da-ef112cf55dcf | 2026-05-18 | Warnings | M012 |
| Mucinex Childrens Day Time Multi-Symptom Cold and Night Time Multi-Symptom Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, AND DIPHENHYDRAMINE HYDROCHLORIDE | Reckitt Benckiser LLC | e3aea6df-37a4-43c5-a192-a902cbff3f92 | 2026-05-18 | Warnings | M012 |
| Mucinex Childrens Cough and Congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | d9e5a8d7-814c-4ab1-bb05-e4cb9155978e | 2026-05-18 | Warnings | M012 |
| Mucinex Childrens Day Time Multi-Symptom Cold and Mucinex Childrens Night Time Multi-Symptom Cold Triple Pack | ACETAMINOPHEN, DIPHENYLHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN | Reckitt Benckiser LLC | c7ab5201-8550-4bf4-957c-c8f049aeaa4a | 2026-05-18 | Warnings | M012 |
| Mucinex Childrens FreeFrom Multi-Symptom Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 84e7be8f-2785-45ef-9c44-de05394fcd99 | 2026-05-18 | Warnings | M012 |
| Mucinex Childrens Multi-Symptom Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 771d7fd8-184f-48a3-90ed-e8f00159d97e | 2026-05-18 | Warnings | M012 |
| MUCINEX Childrens Stuffy Nose | OXYMETAZOLINE HYDROCHLORIDE | Reckitt Benckiser LLC | de1c0abd-1644-4351-8106-e9df6ca5c142 | 2026-05-18 | Warnings | M012 |
| Mucinex Childrens Fever Sore Throat and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | 1538a75d-582a-9501-e063-6394a90a6c55 | 2026-05-18 | Warnings | M012 |
| Mucinex Fast-Max Kickstart Severe Congestion and Cough Maximum Strength | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Reckitt Benckiser LLC | 19105007-0193-0764-e063-6294a90a01a4 | 2026-05-18 | Warnings | M012 |
| Mucinex Fast-Max Kickstart Severe Congestion and Cough and Mucinex Fast-Max Nighttime Cold and Flu | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, ACETAMINOPHEN,TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 34fd2458-9acd-cdf7-e063-6394a90a3d0a | 2026-05-18 | Warnings | M012 |
| MUCINEX FAST-MAX NIGHTTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 3a24b06c-00a6-c2ef-e063-6294a90a4d72 | 2026-05-18 | Warnings | M012 |
| Mucinex Fast-Max Severe Congestion and Cough Maximum Strength | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Reckitt Benckiser LLC | 14be3ab0-d6ae-e342-e063-6294a90ab851 | 2026-05-18 | Warnings | M012 |
| Banophen | DIPHENHYDRAMINE HCL | Bryant Ranch Prepack | 20f00537-2c8a-45d1-8e5f-ec276d0a47b6 | 2026-05-18 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | L.N.K. International, Inc. | 38df2308-f6f9-4476-ad34-4b5bc5f9fdf2 | 2026-05-18 | Warnings | M012 |
| Allergy Plus Headache Relief | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | WALMART INC. | 88e3b969-79d0-4e64-95c0-c5cfd41e365f | 2026-05-18 | 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 |