NDC 54868-4237-7 - 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: 54868-4237-7
Package NDCs from labels: 54868-4237-0, 54868-4237-4, 54868-4237-7
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 table
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 table
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 table
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 table
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#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PHYSICIANS TOTAL CARE, INC.]	9
HYDROCODONE BITARTRATE	ACTIVE INGREDIENT	NO70W886KK	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PHYSICIANS TOTAL CARE, INC.]	9
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PHYSICIANS TOTAL CARE, INC.]	9
HYDROCODONE	ACTIVE MOIETY	6YKS4Y3WQ7	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PHYSICIANS TOTAL CARE, INC.]	9
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PHYSICIANS TOTAL CARE, INC.]	9
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PHYSICIANS TOTAL CARE, INC.]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PHYSICIANS TOTAL CARE, INC.]	9
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PHYSICIANS TOTAL CARE, INC.]	9
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PHYSICIANS TOTAL CARE, INC.]	9
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PHYSICIANS TOTAL CARE, INC.]	9
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PHYSICIANS TOTAL CARE, INC.]	9

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.

Matched openFDA labels page 66 of 185 · 3,699 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen	ACETAMINOPHEN	Granules USA, Inc	a1255f60-b9c6-9a95-e053-2995a90a9e80	2025-12-22	Warnings	Exact identifier unii: 362O9ITL9D
Acetaminophen	ACETAMINOPHEN	Granules USA, Inc	a51395ea-e038-dc9c-e053-2a95a90a287d	2025-12-22	Warnings	Exact identifier unii: 362O9ITL9D
CareALL Acetaminophen	ACETAMINOPHEN	New World Imports, Inc	1148b4d9-fa6a-49e6-9663-17b2c8373846	2025-12-22	Warnings	Exact identifier unii: 362O9ITL9D
Vitapirena	ACETAMINOPHEN	Pharmadel LLC	0547bc1f-d000-f5a6-e063-6294a90ac73d	2025-12-22	Warnings	Exact identifier unii: 362O9ITL9D
CareALL Acetaminophen Extra Strength	ACETAMINOPHEN	New World Imports, Inc	f818417e-0b31-4fe7-8313-4160a00b248a	2025-12-22	Warnings	Exact identifier unii: 362O9ITL9D
CareALL Acetaminophen	ACETAMINOPHEN	New World Imports, Inc	c4f82ed8-b82c-47bb-9ab9-108a13d29cf7	2025-12-22	Warnings	Exact identifier unii: 362O9ITL9D
CareALL Acetaminophen Extra Strength	ACETAMINOPHEN	New World Imports, Inc	5103450a-3095-49cc-9823-4fb4c1d258ff	2025-12-22	Warnings	Exact identifier unii: 362O9ITL9D
CAREALL Non-Aspirin PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	New World Imports, Inc	499b2bf8-72fb-4500-b16e-517cab09a8ae	2025-12-22	Warnings	Exact identifier unii: 362O9ITL9D
CAREALL Pain Relief PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	New World Imports, Inc	933154b9-c9d6-4260-8775-1c83631c74e4	2025-12-22	Warnings	Exact identifier unii: 362O9ITL9D
CAREALL Pain Relief PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	New World Imports, Inc	c93aa5e4-3994-439f-8f14-4e81773ed4e2	2025-12-22	Warnings	Exact identifier unii: 362O9ITL9D
Acetaminophen	ACETAMINOPHEN	Granules USA, Inc.	96131c7b-bdff-0642-e053-2a95a90a4f32	2025-12-22	Warnings	Exact identifier unii: 362O9ITL9D
Acetaminophen Diphenhydramine HCl	ACETAMINOPHEN DIPHENHYDRAMINE HCL	Granules USA, Inc.	8c9f68e3-fedc-6457-e053-2995a90a045a	2025-12-22	Warnings	Exact identifier unii: 362O9ITL9D
Nighttime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Harris Teeter, LLC	89fd57d2-fe49-41cb-b02e-9643e526cf47	2025-12-22	Warnings	Exact identifier unii: 362O9ITL9D
Cold and Flu severe	ACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL	Wal-Mart Stores Inc	9fca25dc-f63e-487a-8b7c-84d65ea51cb5	2025-12-19	Warnings	Exact identifier unii: 362O9ITL9D
Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Geiss, Destin & Dunn Inc.	a7d2eaee-484e-43aa-8ae3-0e050219383f	2025-12-19	Warnings	Exact identifier unii: 362O9ITL9D
Tension Headache Relief	ACETAMINOPHEN, CAFFEINE	NUVICARE LLC	ea4e50e9-2c4d-4e58-b2cb-ab23e91fd50e	2025-12-19	Warnings	Exact identifier unii: 362O9ITL9D
Acetaminophen	ACETAMINOPHEN	WAL-MART STORES INC	940936ac-e59f-7489-e053-2a95a90a6364	2025-12-19	Warnings	Exact identifier unii: 362O9ITL9D
Acetaminophen	ACETAMINOPHEN	WAL-MART STORES INC	e34d07b5-ccbb-cd14-e053-2a95a90a394b	2025-12-19	Warnings	Exact identifier unii: 362O9ITL9D
Acetaminophen and Ibuprofen	ACETAMINOPHEN AND IBUPROFEN	WAL-MART STORES INC.	0aaddde9-4317-a828-e063-6294a90a26d5	2025-12-19	Warnings	Exact identifier unii: 362O9ITL9D
Acetaminophen	ACETAMINOPHEN	Walmart	175495fd-c561-f813-e063-6294a90aac80	2025-12-19	Warnings	Exact identifier unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.