NDC 54868-4237-9 - 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
- 54868-4237-9
- Package NDCs from labels
- 54868-4237-0, 54868-4237-4, 54868-4237-9
- 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 |
|---|---|---|---|---|---|---|
| Night Time Cold and Flu ReadyInCase | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | P & L Development, LLC | e7dd763b-3005-4723-933b-171eb772afee | 2026-01-29 | Warnings | 362O9ITL9D |
| Acetaminophen Extra Strength | ACETAMINOPHEN | FOODHOLD U.S.A., LLC | bc19bd47-69ea-4bcc-8d28-c043c9d32513 | 2026-01-29 | Warnings | 362O9ITL9D |
| Acetaminophen, Guaifenesin, Phenylephrine Hcl and Dextromethorphan HBr | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR | Softgel Healthcare Pvt Ltd | 24bc9ae6-8e8f-c0a0-e063-6394a90a407f | 2026-01-28 | Warnings | 362O9ITL9D |
| Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE | Softgel Healthcare Private Limited | 229d1939-84a9-f18e-e063-6394a90aba30 | 2026-01-28 | Warnings | 362O9ITL9D |
| Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE | SOFTGEL HEALTHCARE PRIVATE LIMITED | 1fcbafaa-c871-db6d-e063-6394a90aab5e | 2026-01-28 | Warnings | 362O9ITL9D |
| Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE | SOFTGEL HEALTHCARE PRIVATE LIMITED | 1f7a6375-ab66-9782-e063-6394a90a99f3 | 2026-01-28 | Warnings | 362O9ITL9D |
| ONESSIP ADULT NIGHTTIME SEVERE COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI | MEDWISE LIFESCIENCES INC. | 4970b8bc-3c7b-4b8a-e063-6294a90a7f1b | 2026-01-28 | Warnings | 362O9ITL9D |
| Extra Strength Mini Softgels Pain Reliever | ACETAMINOPHEN | THE KROGER CO | b49aae4f-b040-44a0-be73-cdf45cf14d7e | 2026-01-28 | Warnings | 362O9ITL9D |
| Extra Strength Acetaminophen | ACETAMINOPHEN | Preferred Pharmaceuticals Inc. | b25faa8c-2d13-450a-970f-81c17a633030 | 2026-01-28 | Warnings | 362O9ITL9D |
| Daytime Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR | Family Dollar (FAMILY WELLNESS) | fe3e74ba-31d9-4d50-ab61-ffb6aaa66085 | 2026-01-28 | Warnings | 362O9ITL9D |
| Leader Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Cardinal Health 110, LLC. dba Leader | 9b1a5dbe-39dd-4dbb-800c-0cef422ae7c5 | 2026-01-28 | Warnings | 362O9ITL9D |
| Cold and Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | 93d5b1db-e9ad-4a6a-b869-fd0d1a11df02 | 2026-01-27 | Warnings | 362O9ITL9D |
| Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE | SOFTGEL HEALTHCARE PRIVATE LIMITED | 37e8ccd5-6be1-9aca-e063-6394a90a5263 | 2026-01-27 | Warnings | 362O9ITL9D |
| Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE | SOFTGEL HEALTHCARE PRIVATE LIMITED | 2f7f078e-de04-9d53-e063-6394a90a409f | 2026-01-27 | Warnings | 362O9ITL9D |
| EXTRA STRENGTH ACETAMINOPHEN | ACETAMINOPHEN | Wal-Mart Stores Inc | a88eba4c-0701-4eec-9a24-a804186fbfd8 | 2026-01-27 | Warnings | 362O9ITL9D |
| EXTRA STRENGTH PAIN RELIEVER PM | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | WALMART INC. | 649e0dd8-ca79-4bf1-9c15-9db9f1d2f5bd | 2026-01-27 | Warnings | 362O9ITL9D |
| TYLENOL Extra Strength | ACETAMINOPHEN | Kenvue Brands LLC | 4961695d-72f3-533a-e063-6294a90a5a29 | 2026-01-27 | Warnings | 362O9ITL9D |
| XL-3 Night Time | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Rnv LLC | 03210929-331e-462d-b566-4e1865f52246 | 2026-01-27 | Warnings | 362O9ITL9D |
| XL-3 Day Time | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Rnv LLC | 2381ff41-4584-4b38-839f-f94e733f5bf2 | 2026-01-27 | Warnings | 362O9ITL9D |
| ACETAMINOPHEN | ACETAMINOPHEN | NuCare Pharmaceuticals, Inc. | 4965fc33-f815-d49e-e063-6394a90a119c | 2026-01-27 | Warnings | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.