NDC 59148-053-07 - Nuedexta
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
- 59148-053
- Requested NDC
- 59148-053-07
- Package NDCs from labels
- 59148-053-16, 59148-053-07, 59148-053-98
- Manufacturer
- Otsuka America Pharmaceutical, Inc
- Effective date
- 2026-01-22
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Nuedexta - Otsuka America Pharmaceutical, Inc | Otsuka America Pharmaceutical, Inc | 2026-01-22 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59148-053-07 | Nuedexta | 13 in 1 BOTTLE | CAPSULE, GELATIN COATED | 13 | 4 | |
| 59148-053-07 | Nuedexta | 1 in 1 CARTON | CAPSULE, GELATIN COATED | 1 | 4 | |
| 59148-053-16 | Nuedexta | 60 in 1 BOTTLE | CAPSULE, GELATIN COATED | 60 | 4 | |
| 59148-053-98 | Nuedexta | 4 in 1 BOX | CAPSULE, GELATIN COATED | 4 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 59148-053 | NUEDEXTA (DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE) CAPSULE, GELATIN COATED [OTSUKA AMERICA PHARMACEUTICAL, INC] | 3 | Current NDC, Legacy NDC, 4 package rows | 20241204_c8cce784-8c5f-415b-8068-76e5d481d159.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59148-053-16 | EA - Each | 59148-053 | ce7e90a9-423b-45f2-a1de-22c3f630b118 | 1 | 2024-10-04 |
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 |
|---|---|---|---|---|---|---|
| Acetaminophen, Dextromethorphan HBr | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | NUVICARE LLC | 6713fdff-0e4e-4a9d-b218-34f786339c57 | 2026-08-06 | Warnings | 9D2RTI9KYH |
| DM Max | DEXTROMETHORPHAN HBR, GUAIFENESIN | Walgreen Company | 78edeb7a-4712-4f04-9d76-d5b2d20ce76d | 2026-08-04 | Warnings | 9D2RTI9KYH |
| CareOne Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | American Sales Company | c9342ad2-84dc-4f4c-9b05-c6e5c1c7989e | 2026-08-04 | Warnings | 9D2RTI9KYH |
| dg health cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Dolgencorp Inc | 3d8ce88e-9f40-4b58-a811-160ddbfb8112 | 2026-08-04 | Warnings | 9D2RTI9KYH |
| Dextromethorphan Hydrobromide and Quinidine Sulphate | DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULPHATE | Golden State Medical Supply, Inc. | 583de7bd-9b82-5e55-e063-6294a90a0bdf | 2026-08-04 | Warnings, Adverse reactions | J13S2394HE 9D2RTI9KYH |
| Chest Congestion Relief DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | DOLGENCORP, LLC | da053bc3-e790-4ae9-a406-2629640e97e7 | 2026-08-04 | Warnings | 9D2RTI9KYH |
| Cold and Flu plus Congestion Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | WALMART INC. | 1236b463-0073-44b5-a516-5b7c06a40887 | 2026-08-04 | Warnings | 9D2RTI9KYH |
| Acetominophen, Dextromethorphan hydrobromide | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Softgel Healthcare Private Limited | 5302bc6d-d947-31c3-e063-6294a90a09f3 | 2026-08-03 | Warnings | 9D2RTI9KYH |
| MUCINEX INSTASOOTHE COUGH | DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | 0d99237c-0b52-0af6-e063-6394a90aba14 | 2026-08-03 | Warnings | 9D2RTI9KYH |
| equaline nighttime cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | United Natural Foods, Inc. dba UNFI | 05e089e7-8772-4bf4-914f-6a26067ee719 | 2026-08-03 | Warnings | 9D2RTI9KYH |
| Tukol Max Action Cold and Flu Nighttime Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Genomma Lab USA | cf0987a3-2c1d-4f40-8551-df9a8e08cd3d | 2026-08-03 | Warnings | 9D2RTI9KYH |
| RIGHT REMEDIES Mucus Relief DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Strive Pharmaceuticals Inc. | 51c4dcfb-8725-d547-e063-6394a90ac04c | 2026-07-31 | Warnings | 9D2RTI9KYH |
| Stona for Children | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Sato Pharmaceutical Co., Ltd. | 18f3d694-9dff-407e-a264-916dbd201f9a | 2026-07-31 | Warnings | 9D2RTI9KYH |
| Rugby Mucus Relief DM ER | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Rugby Laboratories | f2629794-4845-4ca6-8668-a21a56f182cb | 2026-07-30 | Warnings | 9D2RTI9KYH |
| Robitussin Direct Cough | DEXTROMETHORPHAN HYDROBROMIDE | Haleon US Holdings LLC | 70c9556b-063a-4fb3-96f6-1d4ffa495ed4 | 2026-07-30 | Warnings | 9D2RTI9KYH |
| AUVELITY | DEXTROMETHORPHAN HYDROBROMIDE, BUPROPION HYDROCHLORIDE | Axsome Therapeutics, Inc. | dcefda7c-9a68-278e-e053-2995a90aec79 | 2026-07-30 | Boxed warning, Warnings, Adverse reactions | 9D2RTI9KYH |
| up and up mucus relief dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Target Corporation | 9cb3719b-44bc-4ad1-a9c5-e6cc047f4d0e | 2026-07-30 | Warnings | 9D2RTI9KYH |
| ROBITUSSIN LONG-ACTING COUGHGELS | DEXTROMETHORPHAN HYDROBROMIDE | Haleon US Holdings LLC | 472c5c1f-eb5a-444b-a17e-f0d71007fb15 | 2026-07-29 | Warnings | 9D2RTI9KYH |
| TOPCARE NITE TIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Topco Associates LLC | 905d1c5c-65c8-47a3-ad7a-61a4b4b98f0d | 2026-07-29 | Warnings | 9D2RTI9KYH |
| Tussin DM Max Nighttime | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Wal-Mart Stores Inc | 668c92ce-6c1f-4ab3-b0dd-822b0768cb5e | 2026-07-29 | Warnings | 9D2RTI9KYH |