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 | 2026-10-27 |
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 |
|---|---|
| GSL05Y1MN6 | Internal UNII lookup |
| 495W7451VQ | 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 |
|---|---|---|---|---|---|---|
| Alka-Seltzer Plus Maximum Strength Cold and Cough Power Max Gels | ACETAMINOPHEN, CHLORPHENIRAMINE MALAEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 51dec468-fbb2-3489-e054-00144ff88e88 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night | ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | d7711cd6-5058-548d-e053-2a95a90ac54d | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz | CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE | Bayer HealthCare LLC. | a2f0285b-8550-fd26-e053-2995a90ab615 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Cold Day and Night PowerMax gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | f6c73f61-f4fc-377f-e053-6294a90a3797 | 2025-12-04 | Warnings | M012 |
| Alka Seltzer Plus Maximum Strength Cough Chest Congestion PowerFast Fizz | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Bayer Healthcare LLC. | a32e2a5e-9aa0-4e7c-e053-2995a90a3190 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Cold Day and Night PowerMax gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | e2877488-3539-cba2-e053-2995a90a6005 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Cough and Sore Throat FizzyChews | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Bayer HealthCare LLC. | 14951faa-9476-6f29-e063-6394a90a14c7 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cough Mucus and Congestion Liquid Gels | ALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION | Bayer HealthCare LLC. | 0c120569-622d-3a23-e054-00144ff88e88 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Cold and Flu FizzyChews | CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Bayer HealthCare LLC. | 149330be-24bd-b4a4-e063-6394a90a9007 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cough Mucus and Congestion Day and Night | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE, GUAIFENESIN | Bayer HealthCare LLC. | 5278a128-41ec-4494-e054-00144ff8d46c | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Cold Orange Zest | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | 53188c41-3f13-311b-e054-00144ff88e88 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Cold Day and Night | ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | 75894849-a0ba-57be-e053-2a91aa0a049a | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Cold Sparkling Original | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | 531ab703-179a-70ad-e054-00144ff88e88 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Cold Night | ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | 7588ea67-68a9-4dc0-e053-2991aa0aa471 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Cold and Cough | ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | 75862805-2cfe-fb45-e053-2991aa0a1403 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Day Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 5172dc01-4e7f-3307-e054-00144ff8d46c | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Cold and Cough Liquid Gels | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 20ae92d9-fbc6-5b7a-e063-6294a90a15c3 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 51c44970-06e5-082e-e054-00144ff88e88 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 54236151-37db-0b5a-e054-00144ff88e88 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Severe Sinus Congestion and Cough Day and Night | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 52542774-fd05-640c-e054-00144ff8d46c | 2025-12-04 | 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 |