Guaifenesin and Codeine Phosphate
- Product NDC
- 0121-0775
- Requested package NDC
- 0121-0775-04
- 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
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 |
|---|---|---|---|---|---|---|
| WALMART DAYTIME AND NIGHTTIME MS SEVERE RELIEF VALUE PACK | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL | WAL-MART STORES INC | 888bd90a-a059-4814-bd65-6b735ecfaf3a | 2026-08-31 | Warnings | M012 |
| Severe Cold and Flu Daytime and Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Kroger | 49a98411-aa5a-6de3-e063-6294a90a148f | 2026-08-31 | Warnings | M012 |
| equate daytime nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESEN, PHENYLEPHRINE HYDROCHLORIDE | Sixarp, LLC | 5a5a6917-9fb5-e6ca-e063-6394a90af9dc | 2026-08-31 | Warnings | M012 |
| Zicam Intense Sinus Relief | OXYMETAZOLINE HYDROCHLORIDE | Church & Dwight Co., Inc. | d916f7ff-84b7-57ef-e053-2995a90a3efa | 2026-08-31 | Warnings | M012 |
| Afrin Original Nasal | OXYMETAZOLINE HYDROCHLORIDE | JC World Bell Wholesale Co., Inc. | ecfa14b8-a3f3-4569-b489-c9e1a51cf09e | 2026-08-31 | Warnings | M012 |
| Dextromethorphan HBr | DEXTROMETHORPHAN HBR | BIONPHARMA INC. | 5a5dde85-8785-8149-e063-6294a90a4d57 | 2026-08-31 | Warnings | M012 |
| Equate Nasal | OXYMETAZOLINE HCL | Sixarp, LLC | 5a5e2458-bab0-4931-e063-6394a90ad606 | 2026-08-31 | Warnings | M012 |
| MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH RELIEF | DEXTROMETHORPHAN HYDROBROMIDE AND HEXYLRESORCINOL | Reckitt Benckiser LLC | 8d670d91-9e22-45b9-b568-5b62c2133d32 | 2026-08-31 | Warnings | M012 |
| Daytime Cold and Flu Multi Symptom Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Shield Pharmaceuticals Corp | e85b4c2a-d4e0-452c-9a08-fcc0ff6eaa21 | 2026-08-31 | Warnings | M012 |
| Daytime Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Shield Pharmaceuticals Corp | 67849e09-2056-4013-98b1-d003ed3250a2 | 2026-08-31 | Warnings | M012 |
| MAX Tussin Mucus and Chest Congestion Sugar Free | GUAIFENESIN | Akron Pharma Inc. | 3b023b91-e703-4599-9864-96d8c328b45c | 2026-08-31 | Warnings | M012 |
| MAX Tussin Mucus and Chest Congestion | GUAIFENESIN | Akron Pharma Inc. | ac874a31-5556-4669-937f-dcb52aaecd8a | 2026-08-31 | Warnings | M012 |
| MAX Tussin Cough and Chest Congestion DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Akron Pharma Inc. | e0ce4287-bfa1-4413-97c8-4fe2e39bda36 | 2026-08-31 | Warnings | M012 |
| Acetaminophen PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | United Natural Foods, Inc. dba UNFI | 24173e77-92ec-4a87-a471-d6867837c180 | 2026-08-31 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | DOLGENCORP, LLC | 69af44c2-390c-4223-889a-d5555aef5778 | 2026-08-28 | Warnings | M012 |
| Tussin DM Daytime | DEXTROMETHORPHAN HBR, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 432d4833-2eaf-4f7c-b6b4-41043a6b7e2a | 2026-08-28 | Warnings | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Your Military Exchanges | 13fcc43c-bdda-4b65-b6d7-23b39e683651 | 2026-08-28 | Warnings, Adverse reactions | M012 |
| Multi-Symptom Allergy | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Walgreen Company | 5170c450-989d-44fa-ab38-86c78feae3b6 | 2026-08-28 | Warnings | M012 |
| Pain Reliever PM Extra strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Walgreens | 54cbbc5f-908b-47b2-b37f-3646354d3568 | 2026-08-27 | Warnings | M012 |
| Maximum Strength Mucus Relief | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Hyvee Inc | 4e578c7a-88d4-e4cd-e063-6394a90aac44 | 2026-08-27 | 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 |