NDC 0121-0504-15 - Acetaminophen and Codeine Phosphate
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 0121-0504
- Requested NDC
- 0121-0504-15
- Package NDCs from labels
- 0121-0504-04, 0121-0504-16, 0121-0504-05, 0121-0504-40, 0121-0504-15
- Manufacturer
- PAI Holdings, LLC dba PAI Pharma
- Effective date
- 2026-08-06
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Acetaminophen and Codeine Phosphate - PAI Holdings, LLC dba PAI Pharma | PAI Holdings, LLC dba PAI Pharma | 2026-08-06 | HUMAN PRESCRIPTION DRUG LABEL |
| Acetaminophen and Codeine Phosphate - A-S Medication Solutions | A-S Medication Solutions | 2025-01-06 | HUMAN PRESCRIPTION DRUG LABEL |
| Acetaminophen and Codeine Phosphate - Redpharm Drug, Inc | Redpharm Drug, Inc | 2024-07-02 | HUMAN PRESCRIPTION DRUG LABEL |
| Acetaminophen and Codeine Phosphate Oral Solution USP CV | RPK Pharmaceuticals, Inc. | 2023-06-07 | HUMAN PRESCRIPTION DRUG LABEL |
| Acetaminophen and Codeine Phosphate - Proficient Rx LP | Proficient Rx LP | 2021-01-01 | HUMAN PRESCRIPTION DRUG LABEL |
| Acetaminophen and Codeine Phosphate Oral Solution USP CV | NuCare Pharmaceuticals,Inc. | 2020-03-31 | HUMAN PRESCRIPTION DRUG LABEL |
| Acetaminophen and Codeine Phosphate - Aidarex Pharmaceuticals LLC | Aidarex Pharmaceuticals LLC | 2013-11-12 | HUMAN PRESCRIPTION DRUG LABEL |
| Acetaminophen and Codeine Phosphate - Physicians Total Care, Inc. | Physicians Total Care, Inc. | 2010-11-10 | HUMAN PRESCRIPTION DRUG LABEL |
| Acetaminophen and Codeine Phosphate - STAT RX USA LLC | STAT RX USA LLC | 2010-03-15 | HUMAN PRESCRIPTION DRUG LABEL |
| National Council for Prescription Drug Programs indexing - billing unit | National Council for Prescription Drug Programs | 2012-07-24 | Indexing - Billing Unit |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0121-0504-04 | Acetaminophen and Codeine Phosphate | 118 mL in 1 BOTTLE | SOLUTION | 118 | 31 | |
| 0121-0504-05 | Acetaminophen and Codeine Phosphate | 5 mL in 1 CUP, UNIT-DOSE | SOLUTION | 5 | 31 | |
| 0121-0504-16 | Acetaminophen and Codeine Phosphate | 473 mL in 1 BOTTLE | SOLUTION | 473 | 31 | |
| 0121-0504-40 | Acetaminophen and Codeine Phosphate | 40 in 1 CASE | SOLUTION | 40 | 31 | |
| 0121-0504-40 | Acetaminophen and Codeine Phosphate | 10 in 1 TRAY | SOLUTION | 10 | 31 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0121-0504-00 | ML - Milliliter | 0121-0504 | d7a3f004-ca0c-4f1c-ad5c-6c46275f59eb | 1 | 2017-08-11 |
| 0121-0504-04 | ML - Milliliter | 0121-0504 | 969a676e-4598-4cc4-aa2f-60d6e59bcbed | 1 | 2012-07-24 |
| 0121-0504-05 | ML - Milliliter | 0121-0504 | eea7e525-e9ad-4b1e-878d-c5d4bfef77c1 | 1 | 2012-07-24 |
| 0121-0504-10 | ML - Milliliter | 0121-0504 | b2ee4dd9-3150-43a2-a695-2814f460eb5c | 1 | 2012-07-24 |
| 0121-0504-12 | ML - Milliliter | 0121-0504 | 53d82ab1-3ee7-4a3e-81ef-6cf19e25837e | 1 | 2012-07-24 |
| 0121-0504-15 | ML - Milliliter | 0121-0504 | 3fdc83aa-2edd-43ae-a741-d9a7b3f0187f | 1 | 2012-07-24 |
| 0121-0504-16 | ML - Milliliter | 0121-0504 | 0d39973b-5f07-4967-a63b-610e51a8c866 | 1 | 2012-07-24 |
| 0121-0504-40 | ML - Milliliter | 0121-0504 | d1ba4a38-dc9d-4a05-b7f2-983aa8550c19 | 1 | 2024-11-05 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| COLTALIN-DM | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | FORTUNE PHARMACAL COMPANY LIMITED | 33e1bec0-323b-40b7-809a-cb65a71ad0ce | 2026-09-17 | Warnings | 362O9ITL9D |
| Cold and Flu HBP | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE | Kroger Company | fd41e4a4-330f-4409-8ba3-0b3bb6f45bca | 2026-09-10 | Warnings | 362O9ITL9D |
| childrens fever reducer and pain reliever | ACETAMINOPHEN | Rite Aid Corporation | 7f445de3-30cf-4bd8-892d-05979cd399e7 | 2026-09-09 | Warnings | 362O9ITL9D |
| dual action | ACETAMINOPHEN, IBUPROFEN | Rite Aid Corporation | 54b08d24-d5e9-4111-9d97-329896e8309d | 2026-09-09 | Warnings | 362O9ITL9D |
| Mucus Relief Cold Flu and Sore Throat Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Raritan Pharmaceuticals Inc | 2cb3e17f-3858-4773-a53f-0860ae6ff1b9 | 2026-09-09 | Warnings | 362O9ITL9D |
| Advanced Alcohol Gel Sanitizer | ALCOHOL | Betco Corporation, Ltd | a23b997c-b010-5985-e053-2995a90aadf3 | 2026-09-09 | Warnings | 3K9958V90M |
| Touchland Power Mist Hydrating Hand Sanitizer Cotton Candy | ALCOHOL | Church & Dwight Co., Inc. | 5b107dd2-a76c-9c80-e063-6394a90aaedb | 2026-09-09 | Warnings | 3K9958V90M |
| Pink Touchland Power Mist Hydrating Hand Sanitizer Wild Watermelon | ALCOHOL | Church & Dwight Co., Inc. | 5b108f13-6474-fdbd-e063-6294a90a1a2b | 2026-09-09 | Warnings | 3K9958V90M |
| Touchland Power Mist Hydrating Hand Sanitizer Mango Passion | ALCOHOL | Church & Dwight Co., Inc. | 5b1099ae-f1e8-b79d-e063-6394a90add6f | 2026-09-09 | Warnings | 3K9958V90M |
| Touchland Gentle Mist Hand Sanitizer Lily of The Valley | ALCOHOL | Church & Dwight Co., Inc. | 5b10a3a7-1cca-2a34-e063-6294a90a3f6c | 2026-09-09 | Warnings | 3K9958V90M |
| Touchland Glow Mist Hand Sanitizer Rosewater | ALCOHOL | Church & Dwight Co., Inc. | 5a850866-bc5d-e595-e063-6394a90a335f | 2026-09-09 | Warnings | 3K9958V90M |
| Leader Eye Drops Redness Relief | GLYCERIN, NAPHAZOLINE HYDROCHLORIDE | Cardinal Health | aee4bbe2-4f11-4c54-be8b-df48b3ba4f3a | 2026-09-09 | Warnings | PDC6A3C0OX |
| severe cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Rite Aid Corporation | 4b8ae971-ab57-4937-a878-72d905d7b849 | 2026-09-09 | Warnings | 362O9ITL9D |
| Cold and Flu Relief | ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | CARDINAL HEALTH 110, LLC. DBA LEADER 70000 | 82ba9a73-60ef-49fd-960f-5ca2bb79555e | 2026-09-09 | Warnings | 362O9ITL9D |
| Hemorrhoidal | GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM | Rite Aid Corporation | 407c78ca-6fee-4ed6-b61b-711ec049c86e | 2026-09-09 | Warnings | PDC6A3C0OX |
| DRx Choice maximum strength Severe Cough plus sore throat | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | RARITAN PHARMACEUTICALS | a096cb76-0d1c-4ca8-854a-5199da0bc8f7 | 2026-09-09 | Warnings | 362O9ITL9D |
| Acetaminophen Extra Strength | ACETAMINOPHEN | Wal-Mart Stores Inc | 78874258-16cc-40b5-9e15-5943eddfce94 | 2026-09-08 | Warnings | 362O9ITL9D |
| Vicks DayQuil VapoCOOL SEVERE COLD and FLU plus CONGESTION | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | The Procter & Gamble Manufacturing Company | efb69cc1-a745-6efc-e053-2a95a90abdc9 | 2026-09-08 | Warnings | 362O9ITL9D |
| Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTION | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE | The Procter & Gamble Manufacturing Company | efb5f0b9-9825-ab23-e053-2995a90a26ab | 2026-09-08 | Warnings | 362O9ITL9D |
| Clear Eyes Nighttime | GLYCERIN | Prestige Brands Holdings, Inc. | af75e2f7-81dd-43e0-a390-b52bbfbebf62 | 2026-09-08 | Warnings | PDC6A3C0OX |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.