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
- CODEINE PHOSPHATE; GUAIFENESIN
- Active strength
- 10; 100 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 | 2026-08-03 |
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 | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0121-0775 | 0121-0775-08 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0121-0775 | 0121-0775-08 | D | Discontinued by firm | excluded / ndc_excluded.zip | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 0121-0775 | 0121-0775-08 | D | Discontinued by firm | excluded / ndc_excluded.zip | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 0121-0775 | 0121-0775-08 | D | Discontinued by firm | excluded / ndc_excluded.zip | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 0121-0775 | 0121-0775-08 | D | Discontinued by firm | excluded / ndc_excluded.zip | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 0121-0775 | 0121-0775-08 | D | Discontinued by firm | excluded / ndc_excluded.zip | cdf11ea48f46… | ba0047e9e063… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 0121-0775 | 0121-0775-08 | D | Discontinued by firm | excluded / ndc_excluded.zip | 302b2466d912… | e7b80fea0513… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 0121-0775 | 0121-0775-08 | D | Discontinued by firm | excluded / ndc_excluded.zip | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0121-0775 | 0121-0775-08 | D | Discontinued by firm | excluded / ndc_excluded.zip | 0efc9e666f02… | f202fb6c5f17… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 0121-0775 | 0121-0775-08 | D | Discontinued by firm | excluded / ndc_excluded.zip | ad56d346431e… | cc804d4bbf1e… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 0121-0775 | 0121-0775-08 | D | Discontinued by firm | excluded / ndc_excluded.zip | 367a005e9d99… | 383a685ebd0f… |
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 |
|---|---|---|---|---|---|---|
| Severe Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Family Dollar Services Inc | ce590997-3cae-4f22-ac39-2b14d39494bc | 2026-07-30 | Warnings | M012 |
| Robitussin Direct Cough | DEXTROMETHORPHAN HYDROBROMIDE | Haleon US Holdings LLC | 70c9556b-063a-4fb3-96f6-1d4ffa495ed4 | 2026-07-30 | Warnings | M012 |
| Major Nasal Decongestant | OXYMETAZOLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | a302e341-1c00-4c3d-b71f-c4c0b307aa67 | 2026-07-29 | Warnings | M012 |
| Pain Reliever PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Walgreens | 4c737cd6-fe56-4cef-887c-cd6cf83b254c | 2026-07-29 | Warnings | M012 |
| ROBITUSSIN LONG-ACTING COUGHGELS | DEXTROMETHORPHAN HYDROBROMIDE | Haleon US Holdings LLC | 472c5c1f-eb5a-444b-a17e-f0d71007fb15 | 2026-07-29 | Warnings | M012 |
| DAYTIME COLD AND FLU NITETIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Meijer Distribution Inc | 3a33c6ce-aada-4099-8c61-49c86c0fc1a8 | 2026-07-29 | Warnings | M012 |
| Tussin DM Max Nighttime | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Wal-Mart Stores Inc | 668c92ce-6c1f-4ab3-b0dd-822b0768cb5e | 2026-07-29 | Warnings | M012 |
| Benadryl | DIPHENHYDRAMINE HYDROCHLORIDE | Kenvue Brands LLC | 702f9786-7ce9-43e4-921d-e1db09612127 | 2026-07-28 | Warnings | M012 |
| LoHist-D | CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL | Larken Laboratories, Inc. | efaa354e-c25c-405b-9d30-001c2796978c | 2026-07-28 | Warnings | M012 |
| NIGHTTIME SEVERE COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | d1115a55-35cd-4f20-8872-f42983a5ebcd | 2026-07-28 | Warnings | M012 |
| TUSSIN | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Safeway | a5e2bda4-2da6-4c20-855d-2888dadf0c3a | 2026-07-28 | Warnings | M012 |
| DM Maximum | DEXTROMETHORPHAN HBR, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | f6029b04-e681-40fc-be4f-14091b76dd4e | 2026-07-27 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | CVS PHARMACY | e958eef1-8aae-4365-ac64-95a9e8e7e0f2 | 2026-07-27 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | DOLGENCORP INC | 38400854-27fa-e291-e063-6294a90a5c4e | 2026-07-27 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Better Living Brands, LLC | 65802aa7-64e7-4435-ad6b-65895fba17ce | 2026-07-27 | Warnings | M012 |
| Cold and Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCL | Walgreen Company | 0a48f650-ad2a-4105-9ff4-2bc4d94b46d3 | 2026-07-27 | Warnings | M012 |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | 84202ebe-97b6-4be2-bb09-7f2729303f96 | 2026-07-27 | Warnings | M012 |
| Daytime Severe Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Rite Aid Corporation | 8d41defe-8120-4cbb-b42e-c805cc5a794b | 2026-07-24 | Warnings | M012 |
| Childrens Benadryl ALLERGY | DIPHENHYDRAMINE HYDROCHLORIDE | Kenvue Brands LLC | fc9181b9-c92d-493e-8d7c-4a4239c6c092 | 2026-07-24 | Warnings | M012 |
| Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE | Prodose, Inc. | 3afc88c7-388a-dbd9-e063-6294a90a4faf | 2026-07-24 | Warnings | M012 |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Guaifenesin and Codeine Phosphate
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| GUAIFENESIN | 10 mg/5mL |
| CODEINE PHOSPHATE | 100 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 | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0121-0775-04 | 2022-03-28 | C162847 | 48780-1 | d6a99b39-4ea2-a426-e053-dadaa90af4c2 | Guaifenesin and Codeine Phosphate |
| 0121-0775-08 | 2022-03-28 | C162847 | 48780-1 | d6a99b39-4ea2-a426-e053-dadaa90af4c2 | Guaifenesin and Codeine Phosphate |
| 0121-0775-16 | 2022-03-28 | C162847 | 48780-1 | d6a99b39-4ea2-a426-e053-dadaa90af4c2 | Guaifenesin and Codeine Phosphate |
| 0121-0775-04 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-4ea2-a426-e053-dadaa90af4c2 | Guaifenesin and Codeine Phosphate |
| 0121-0775-08 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-4ea2-a426-e053-dadaa90af4c2 | Guaifenesin and Codeine Phosphate |
| 0121-0775-16 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-4ea2-a426-e053-dadaa90af4c2 | 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#
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 |