NDC 54868-3585-2 - 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
- 54868-3585
- Requested NDC
- 54868-3585-2
- Package NDCs from labels
- 54868-3585-5, 54868-3585-2
- Manufacturer
- Physicians Total Care, Inc.
- Effective date
- 2014-02-17
- 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. | 2014-02-17 | 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 |
|---|---|---|---|---|---|---|
| 54868-3585-5 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 120 in 1 BOTTLE, PLASTIC | TABLET | 120 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 54868-3585 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PHYSICIANS TOTAL CARE, INC.] | 5 | 1 package rows | 20140217_ab52a549-8ecc-441a-8733-0fda146e9932.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 54868-3585-0 | EA - Each | 54868-3585 | c3f7bb28-3883-49b4-9ab7-8a1084cadc9f | 1 | 2012-07-24 |
| 54868-3585-1 | EA - Each | 54868-3585 | 02f5ecde-20a9-45d9-9daf-0458cb4fc6a1 | 1 | 2012-07-24 |
| 54868-3585-2 | EA - Each | 54868-3585 | 9801ac21-07dc-4ae9-a3c4-ea74673ffb1d | 1 | 2012-07-24 |
| 54868-3585-3 | EA - Each | 54868-3585 | 402e281e-0440-40a7-af62-c4ea8810f805 | 1 | 2012-07-24 |
| 54868-3585-5 | EA - Each | 54868-3585 | 73a2c3fa-a4d6-4949-af38-cbf3656dbbc4 | 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 |
|---|---|---|---|---|---|---|
| Gelusil | ALUMINA, MAGNESIA, SIMETHICONE | WellSpring Pharmaceutical Corporation | 92fbeec1-1562-40f3-9734-41f133d494f9 | 2025-11-20 | Warnings | ETJ7Z6XBU4 |
| Arthritis Pain | ACETAMINOPHEN | AMERIFOODS TRADING COMPANY | 3802bc07-3154-f36a-e063-6294a90ac1cc | 2025-11-20 | Warnings | 362O9ITL9D |
| Pain Relief | ACETAMINOPHEN | HYVEE INC | 4227aeb1-dd2c-9ca1-e063-6294a90ad709 | 2025-11-20 | Warnings | 362O9ITL9D |
| good sense pain relief | ACETAMINOPHEN | NuCare Pharamceuticals, Inc. | 440c13d7-edf0-f611-e063-6394a90af995 | 2025-11-20 | Warnings | 362O9ITL9D |
| Pain Relief | ACETAMINOPHEN | HYVEE INC | 42394377-c874-a955-e063-6294a90ace0b | 2025-11-20 | Warnings | 362O9ITL9D |
| Pain Relief | ACETAMINOPHEN | HYVEE INC | 4227a2cc-69fa-869d-e063-6294a90a1d41 | 2025-11-20 | Warnings | 362O9ITL9D |
| Pain Relief | ACETAMINOPHEN | HYVEE INC | 422796ed-7558-f7e8-e063-6294a90ad1c7 | 2025-11-20 | Warnings | 362O9ITL9D |
| Arthritis Pain | ACETAMINOPHEN | HYVEE INC | 3e61b583-c1cb-23bd-e063-6294a90aa006 | 2025-11-20 | Warnings | 362O9ITL9D |
| Pain Relief | ACETAMINOPHEN | HYVEE INC | 3e61abe4-b4be-01af-e063-6394a90a8b24 | 2025-11-20 | Warnings | 362O9ITL9D |
| Pain Relief PM | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | HYVEE INC | 3e60703b-a5cf-333a-e063-6394a90a2087 | 2025-11-20 | Warnings | 362O9ITL9D |
| Cold | BAPTISIA TINCTORIA, ECHINACEA ANGUSTIFOLIA, EUPATORIUM PERFOLIATUM, LOMATIUM DISSECTUM, PUERARIA LOBATA, TRIFOLIUM PRATENSE, PHYTOLACCA DECANDRA, ALLIUM CEPA, ARSENICUM IODATUM, BARYTA CARBONICA, BROMIUM, CALCAREA CARBONICA, KALI MURIATICUM, LACHESIS MUTUS, MERCURIUS SOLUBILIS, SILICEA | Natural Creations, Inc | c45d1d8f-24be-4c13-8c4b-388962421415 | 2025-11-20 | Warnings | ETJ7Z6XBU4 |
| Endometrium Argentum | ENDOMETRIUM ARGENTUM | Uriel Pharmacy Inc. | 5590d577-3a98-49b8-bb12-ddd7f5cfd080 | 2025-11-19 | Warnings | ETJ7Z6XBU4 |
| Dizziness HP | CALCAREA CARBONICA, CHENOPODIUM ANTHELMINTICUM, COCCULUS INDICUS, CONIUM MACULATUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, TABACUM, | Energique, Inc. | 0bf53ecc-c2ad-40b5-b921-7c10a1b00626 | 2025-11-19 | Warnings | ETJ7Z6XBU4 |
| Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Haleon US Holdings LLC | a6f750c8-8738-4965-a3ad-612c24611056 | 2025-11-18 | Warnings | 362O9ITL9D |
| YINCHIAO | ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE | ANHUI DONGSHENGYOUBANG PHARMACEUTICAL CO., LTD. | 09ba45f6-03e1-46b9-83ab-a618b2626716 | 2025-11-18 | Warnings | 362O9ITL9D |
| GANMAOLING | ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE | ANHUI DONGSHENGYOUBANG PHARMACEUTICAL CO., LTD. | c757a03e-59ea-469c-970d-4bc62e73f36f | 2025-11-18 | Warnings | 362O9ITL9D |
| MIDOL COMPLETE | ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE | R J General Corporation | 0c09a178-1a07-4079-b4a6-d1657cb8e714 | 2025-11-17 | Warnings | 362O9ITL9D |
| Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz | CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE | R J General Corporation | d786ae07-ce57-44c7-9ba5-f4c87df115de | 2025-11-17 | Warnings | 362O9ITL9D |
| TYLENOL COLD AND FLU | ACETAMINPHEN | R J General Corporation | b618877b-9dbc-4ba2-be2c-bf1922c646cc | 2025-11-17 | Warnings | 362O9ITL9D |
| TYLENOL SINUS SEVERE | ACETAMINOPHEN | R J General Corporation | 2cbf7954-b28f-4d7b-b142-6c6c5c58b25d | 2025-11-17 | Warnings | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.