NDC 54868-4237-5 - HYDROCODONE BITARTRATE AND ACETAMINOPHEN
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
- 54868-4237
- Requested NDC
- 54868-4237-5
- Package NDCs from labels
- 54868-4237-0, 54868-4237-4, 54868-4237-5
- Manufacturer
- Physicians Total Care, Inc.
- Effective date
- 2014-04-03
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP CIII | Physicians Total Care, Inc. | 2014-04-03 | 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54868-4237-0 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 20 in 1 BOTTLE | TABLET | 20 | 9 | |
| 54868-4237-4 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 30 in 1 BOTTLE | TABLET | 30 | 9 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 54868-4237 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PHYSICIANS TOTAL CARE, INC.] | 9 | 2 package rows | 20140403_8f5d00de-3b9b-46d4-b374-1cf329a4c1db.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 54868-4237-0 | EA - Each | 54868-4237 | bb31b128-549e-4fdb-b9b0-543112f180ff | 1 | 2012-07-24 |
| 54868-4237-1 | EA - Each | 54868-4237 | 6d53310e-8693-4fcc-95a2-996e1379b41e | 1 | 2012-07-24 |
| 54868-4237-2 | EA - Each | 54868-4237 | 441549e5-4acf-4495-8e66-8c3ab0757f48 | 1 | 2012-07-24 |
| 54868-4237-3 | EA - Each | 54868-4237 | eaf77609-d88d-4670-9e0f-b97e06503175 | 1 | 2012-07-24 |
| 54868-4237-4 | EA - Each | 54868-4237 | 462f01cc-d536-466e-8c3e-e9115b6806d0 | 1 | 2012-07-24 |
| 54868-4237-5 | EA - Each | 54868-4237 | 54f6ca8c-9534-4202-aaa0-2fd2d5cbebeb | 1 | 2012-07-24 |
| 54868-4237-6 | EA - Each | 54868-4237 | 3292499c-9552-4e91-978a-77ed8d3649c1 | 1 | 2012-07-24 |
| 54868-4237-7 | EA - Each | 54868-4237 | 304bcfcf-be65-4392-8f0c-cb64b50aef44 | 1 | 2012-07-24 |
| 54868-4237-8 | EA - Each | 54868-4237 | d85056c3-fc5b-460b-ba98-3c98ed26cb1a | 1 | 2012-07-24 |
| 54868-4237-9 | EA - Each | 54868-4237 | d9477990-2170-4bd4-b78a-0f9227da55b7 | 1 | 2012-07-24 |
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 |
|---|---|---|---|---|---|---|
| Dye Free Infants Pain and Fever | ACETAMINOPHEN | WALGREENS | 0b1d88d8-56ff-9e9d-e063-6394a90a015c | 2024-04-09 | Warnings | 362O9ITL9D |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN, CAFFEINE | H E B | 4d572228-3141-4539-9c3d-2fd06e94eee3 | 2024-04-09 | Warnings | 362O9ITL9D |
| Daytime Cold and Flu Non drowsy | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Harris Teeter, LLC | 9b0648ac-0ce3-4eaa-8977-26ae864f034d | 2024-04-09 | Warnings | 362O9ITL9D |
| FLONASE Headache and Allergy Relief | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 282c103c-3888-4a35-a5b1-d492ed6892c1 | 2024-04-08 | Warnings | 362O9ITL9D |
| Robitussin Direct Sore Throat Pain | ACETAMINOPHEN | Haleon US Holdings LLC | 1b512078-24c3-4b80-8f2c-d6824d367f25 | 2024-04-08 | Warnings | 362O9ITL9D |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | 4da8a7bd-0d2e-452c-afb5-fed4e230a9bd | 2024-04-08 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Cold and Flu Relief Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | H E B | 12ace982-bd47-49b0-ba1b-e0a29d42f1d6 | 2024-04-08 | Warnings | 362O9ITL9D |
| Cold and Flu Relief Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | H E B | bd19b1f2-d9d3-4dab-8181-605f769ab62f | 2024-04-08 | Warnings | 362O9ITL9D |
| Daytime Severe Cold and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | H E B | 9f533092-060c-4379-9a77-ecfea8aa46e1 | 2024-04-08 | Warnings | 362O9ITL9D |
| Robitussin Severe Multi-Symptom Cough Cold Flu Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE | Haleon US Holdings LLC | 89360fa8-014d-4da8-bb1c-197e3aa52256 | 2024-04-06 | Warnings | 362O9ITL9D |
| Robitussin Severe Multi-Symptom Cough Cold Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Haleon US Holdings LLC | 66360295-f364-479a-8b49-c12b21918279 | 2024-04-06 | Warnings | 362O9ITL9D |
| Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Haleon US Holdings LLC | e7cf7c5d-5c9a-4201-9e30-1cd616071855 | 2024-04-06 | Warnings | 362O9ITL9D |
| Theraflu Severe Cold Relief Daytime Honey Ginger | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | 44404c6a-8031-4f4b-a48e-3739a11a0d2c | 2024-04-05 | Warnings | 362O9ITL9D |
| Excedrin Extra Strength Pain Reliever | ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE | Haleon US Holdings LLC | 1b5ff867-5442-4cf8-bd1e-530093cc88f8 | 2024-04-05 | Warnings | 362O9ITL9D |
| Activcin | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | OPMX LLC. | e06a4d72-cc8d-fd9d-e053-2995a90a7a76 | 2024-04-05 | Warnings | 362O9ITL9D |
| Coldtac Plus Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | OPMX LLC. | ff5ce5c6-a03f-2ad3-e053-6394a90a99f6 | 2024-04-05 | Warnings | 362O9ITL9D |
| Desresfriol-DX Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | OPMX LLC. | ff5e0e0f-bfd2-b02b-e053-6394a90afe8a | 2024-04-05 | Warnings | 362O9ITL9D |
| Excedrin Extra Strength Pain Reliever | ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE | Haleon US Holdings LLC | 0faa3592-4d56-4645-9a0e-066e0bdfebb6 | 2024-04-05 | Warnings | 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN TABLET EXTENDED RELEASE | Bryant Ranch Prepack | 61ea1796-b9c7-4cb9-9a36-60943f884875 | 2024-04-05 | Warnings | 362O9ITL9D |
| Butalbital, Acetaminophen, Caffeine and Codeine Phosphate | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | Bryant Ranch Prepack | 215e2a6f-ec32-4836-8fad-22c8b40ba1f1 | 2024-04-04 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.