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 154 of 184 · 3,664 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Pain and Fever Dye Free	ACETAMINOPHEN	KROGER COMPANY	0fec66b4-3a2a-63d1-e063-6294a90a6d72	2024-04-17	Warnings	Exact identifier unii: 362O9ITL9D
MULTI-SYMPTOM COLD AND FLU RELIEF DAYTIME	ACETAMINOPHEN 325 MG DEXTROMETHORPHAN HBR 10 MG PHENYLEPHRINE HCI 5 MG	RITE AID	c92dbbbb-d149-1e7e-e053-2a95a90a6f1a	2024-04-17	Warnings	Exact identifier unii: 362O9ITL9D
MULTI-SYMPTOM COLD AND FLU RELIEF NIGHTTIME	ACETAMINOPHEN 325 MG DEXTROMETHORPHAN HBR 15 MG DOXYLAMINE SUCCINATE 6.25 MG	RITE AID	c9323799-3505-d6c1-e053-2995a90a6f43	2024-04-17	Warnings	Exact identifier unii: 362O9ITL9D
Nighttime Cold and Flu Relief	ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE	QUALITY CHOICE (Chain Drug Marketing Association)	fac8b01a-9666-43cc-a4ff-3f3ed452c7e4	2024-04-17	Warnings	Exact identifier unii: 362O9ITL9D
8 Hour Pain Relief	ACETAMINOPHEN	KROGER COMPANY	0fec5c67-8d5d-8e45-e063-6394a90a982a	2024-04-15	Warnings	Exact identifier unii: 362O9ITL9D
ADVIL DUAL ACTION WITH ACETAMINOPHEN	IBUPROFEN, ACETAMINOPHEN	Navajo Manufacturing Company Inc.	bd0d7812-4e42-b533-e053-2995a90ae1f9	2024-04-15	Warnings	Exact identifier unii: 362O9ITL9D
Handy Solutions Headache Pain Relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Navajo Manufacturing Company Inc.	e5481abe-6971-2bc5-e053-2995a90ae895	2024-04-15	Warnings	Exact identifier unii: 362O9ITL9D
Nighttime Severe Cold and Cough	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	P & L Development, LLC	8d27b94d-23a1-4e6c-a064-79e2580f7e2e	2024-04-15	Warnings	Exact identifier unii: 362O9ITL9D
Severe Cold and Cough Relief Daytime	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	P & L Development, LLC	2af496a1-6fdd-4acf-9944-8b7cdf302275	2024-04-15	Warnings	Exact identifier unii: 362O9ITL9D
childrens acetaminophen	ACETAMINOPHEN	Major Pharmaceuticals	243a5cff-e506-434b-ab19-1a6ac53f8533	2024-04-15	Warnings	Exact identifier unii: 362O9ITL9D
Dye Free Pain Reliever Childrens	ACETAMINOPHEN	P & L Development, LLC	45ddcaad-d416-4d7c-a84a-43548d5c5d3b	2024-04-15	Warnings	Exact identifier unii: 362O9ITL9D
Tylenol Extra Strength	ACETAMINOPHEN	Navajo Manufacturing Company Inc.	65bf1556-f25a-9439-e053-2a91aa0a3194	2024-04-15	Warnings	Exact identifier unii: 362O9ITL9D
ACETAMINOPHEN	ACETAMINOPHEN	Kroger Company	bbeebdd6-fe2c-5b8a-e053-2a95a90ab95e	2024-04-13	Warnings	Exact identifier unii: 362O9ITL9D
infants pain relief	ACETAMINOPHEN	Publix Super Markets Inc	3d1818a7-d3b2-434c-b3c9-b2713f08ded2	2024-04-13	Warnings	Exact identifier unii: 362O9ITL9D
Mommys Bliss Childrens Pain and Fever	ACETAMINOPHEN	Mom Enterprises, LLC.	08b9eaf7-70d1-640f-e063-6394a90a8d3b	2024-04-12	Warnings	Exact identifier unii: 362O9ITL9D
Mommys Bliss Infants Pain and Fever	ACETAMINOPHEN	Mom Enterprises, LLC.	05e26650-81b3-d7b1-e063-6394a90a14ed	2024-04-11	Warnings	Exact identifier unii: 362O9ITL9D
Childrens Pain Relief	CHILDRENS PAIN RELIEF	Allegiant Health	7381dd26-c507-4d02-b989-cfd96e02f495	2024-04-11	Warnings	Exact identifier unii: 362O9ITL9D
Childrens Pain Relief Dye-Free	ACTEAMINOPHEN	WinCo Foods, LLC	5ee134b3-b8e9-4621-b0a1-a84d9867ccba	2024-04-11	Warnings	Exact identifier unii: 362O9ITL9D
Childrens Pain and Fever	ACETAMINOPHEN	WALGREENS	0b1d086f-7be1-5072-e063-6394a90a11e6	2024-04-10	Warnings	Exact identifier unii: 362O9ITL9D
Dye Free Infants Pain and Fever	ACETAMINOPHEN	WALGREENS	0b1d88d8-56ff-9e9d-e063-6394a90a015c	2024-04-09	Warnings	Exact identifier unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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