NDC 54868-4237-3 - 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
- 54868-4237-3
- Package NDCs from labels
- 54868-4237-0, 54868-4237-4, 54868-4237-3
- 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 |
|---|---|---|---|---|---|---|
| Pain Relief Extra Strength | ACETAMINOPHEN | TopCo Associates LLC | bdb01b3e-ad34-4003-9b9a-e83a2c0e90bb | 2024-12-02 | Warnings | 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN | CVS Pharmacy, Inc | c4473ee6-4e01-1ec2-e053-2995a90ac513 | 2024-12-02 | Warnings | 362O9ITL9D |
| Geovita | CEREBRUM, CUPRUM MET, FERRUM MET, FORMICUM ACIDUM, SILICEA | RUBIMED AG | 0fcb5c06-d414-456c-a0ef-28e14018a781 | 2024-11-29 | Warnings | ETJ7Z6XBU4 |
| Childrens Chewable Acetaminophen | ACETAMINOPHEN | GERI-CARE PHARMACEUTICAL CORP | 22f63d62-c941-5b8f-e063-6394a90aeecd | 2024-11-28 | Warnings | 362O9ITL9D |
| Extra Strength Acetaminophen | ACETAMINOPHEN | Geri-Care Pharmaceutical Corp | 7a7b6318-b7d6-31b1-e053-2991aa0abf25 | 2024-11-28 | Warnings | 362O9ITL9D |
| Extra Strength Pain Reliever PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | INGLES MARKETS, INC. | 27fd288e-c07a-617f-e063-6394a90a17a4 | 2024-11-28 | Warnings | 362O9ITL9D |
| EXCEDRIN MIGRAINE | ACETAMINOPHEN, ASPIRIN (NSAID) AND CAFFEINE | Jones Healthcare Group - Packaging Services, Inc | c4168e4d-3dfc-4e51-a32e-14704cb59c66 | 2024-11-27 | Warnings | 362O9ITL9D |
| Severe Sinus Congestion Allergy and Cough Formula | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | PuraCap Pharmaceutical LLC | 36a4ec1f-50c3-4d61-ada9-987ccad3563c | 2024-11-26 | Warnings | 362O9ITL9D |
| Para-Si | JUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBER | Newton Laboratories, Inc. | 27d41602-9dcb-eaa8-e063-6394a90a7cfa | 2024-11-26 | Warnings | ETJ7Z6XBU4 |
| Para-Si | JUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHEIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBER | Newton Laboratories, Inc. | 27d4ddaf-9c07-a7fc-e063-6394a90adc0b | 2024-11-26 | Warnings | ETJ7Z6XBU4 |
| Para-Si | JUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBER | Newton Laboratories, Inc. | 27d5997b-1cae-41c2-e063-6394a90ac74a | 2024-11-26 | Warnings | ETJ7Z6XBU4 |
| First Aid Only Extra-Strength Non-Aspirin | ACETAMINOPHEN | Acme United Corporation | 6891d57a-10a6-53de-e053-2a91aa0ac7c2 | 2024-11-26 | Warnings | 362O9ITL9D |
| BRONCOCHEM COLD AND FLU CAPLETS | ACETAMINOPHEN-DEXTROMETHORPHAN HBR-PHENYLEPHRINE HCL-CHLORPHENIRAMINE MALEATE | LABORATORIO MAGNACHEM INTERNATIONAL SRL | ac4f6a39-e455-4d33-8bb8-ae8dc6ebc2f6 | 2024-11-26 | Warnings | 362O9ITL9D |
| Alka-Seltzer Plus Cold and Flu, CVP | CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE TABLET | Lil' Drug Store Products, Inc. | e7a27773-69d6-9e07-e053-2a95a90af8ea | 2024-11-25 | Warnings | 362O9ITL9D |
| ACETAMINOPHEN (RED) | ACETAMINOPHEN | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 06eabf4b-f8c0-439a-acf1-aa6e3075c717 | 2024-11-25 | Warnings | 362O9ITL9D |
| ACETAMINOPHEN (RED) | ACETAMINOPHEN | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd | a352f588-4a70-42b2-8f9c-a73a0629517d | 2024-11-25 | Warnings | 362O9ITL9D |
| DayTime Sinus Relief | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 4361912e-4b56-4743-b11d-acfb94482a2e | 2024-11-25 | Warnings | 362O9ITL9D |
| NightTime Sinus Relief | ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 413d82d3-a896-4f15-9fca-c1b7b9a1ee63 | 2024-11-25 | Warnings | 362O9ITL9D |
| Pain Relief Extra Strength | ACETAMINOPHEN | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 5c42dd28-820c-4cc5-9016-11ad5e580616 | 2024-11-25 | Warnings | 362O9ITL9D |
| Night Cold Flu Cough and Allergy | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 590f4f0d-c8b0-412d-be1e-3eb2ccb29ac0 | 2024-11-25 | Warnings | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.