NDC 66689-005-01 - 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: 66689-005
Requested NDC: 66689-005-01
Package NDCs from labels: 66689-005-01, 66689-005-50
Manufacturer: VistaPharm, LLC
Effective date: 2024-07-11
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 - VistaPharm, LLC	VistaPharm, LLC	2024-07-11	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
66689-005-50	2024-01-30	C162847	48780-1	1030e365-0938-111a-e063-dadaa90a10e2	Hydrocodone Bitartrate and Acetaminophen Oral Solution, CII

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66689-005-01	ML - Milliliter	66689-005	0047ce97-2c9b-4817-adc1-22461f69467e	1	2019-07-02
66689-005-50	ML - Milliliter	66689-005	3bfc0e60-dde1-4375-abfe-cc156f1aae28	1	2019-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Acetaminophen	ACTIVE INGREDIENT	362O9ITL9D	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [VISTAPHARM INC.]	4
Hydrocodone Bitartrate	ACTIVE INGREDIENT	NO70W886KK	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [VISTAPHARM INC.]	4
Acetaminophen	ACTIVE MOIETY	362O9ITL9D	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [VISTAPHARM INC.]	4
Hydrocodone	ACTIVE MOIETY	6YKS4Y3WQ7	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [VISTAPHARM INC.]	4
Anhydrous Citric Acid	INACTIVE INGREDIENT	XF417D3PSL	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [VISTAPHARM INC.]	4
Ethyl Maltol	INACTIVE INGREDIENT	L6Q8K29L05	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [VISTAPHARM INC.]	4
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [VISTAPHARM INC.]	4
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [VISTAPHARM INC.]	4
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [VISTAPHARM INC.]	4
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [VISTAPHARM INC.]	4
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [VISTAPHARM INC.]	4
Saccharin Sodium	INACTIVE INGREDIENT	SB8ZUX40TY	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [VISTAPHARM INC.]	4
Sorbitol	INACTIVE INGREDIENT	506T60A25R	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [VISTAPHARM INC.]	4
Sucrose	INACTIVE INGREDIENT	C151H8M554	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [VISTAPHARM INC.]	4
Trisodium Citrate Dihydrate	INACTIVE INGREDIENT	B22547B95K	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [VISTAPHARM INC.]	4
Water	INACTIVE INGREDIENT	059QF0KO0R	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [VISTAPHARM INC.]	4

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 123 of 181 · 3,613 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Publix Fast Relief Effervescent	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Publix Super Markets Inc.	73051f16-2569-7394-e053-2991aa0a5359	2024-11-13	Warnings	Exact identifier unii: XF417D3PSL
Quality Choice Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Chain Drug Marketing Association	70d265de-ff94-e0e4-e053-2a91aa0a962a	2024-11-13	Warnings	Exact identifier unii: XF417D3PSL
Quality Choice Extra Strength Effervescent Antacid and Pain Relief	ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE	Chain Drug Marketing Association	9f7d0c96-a561-a8a0-e053-2995a90a250b	2024-11-13	Warnings	Exact identifier unii: XF417D3PSL
WinCo Foods Effervescent Antacid and Pain Relief	ASPIRIN, SODIUM BICARBONATE, CITRIC ACID TABLET	WinCo Foods, LLC	0c8a755a-089f-477f-97e9-0dd6fdfbe99d	2024-11-13	Warnings	Exact identifier unii: XF417D3PSL
Focus	ADENOSINUM CYCLOPHOSPHORICUM, ADRENALINUM, AETHUSA CYNAPIUM, ALPHA-KETOGLUTARICUM ACIDUM, AMBRA GRISEA, BARYTA CARBONICA, CANDIDA ALBICANS, CARBONEUM SULPHURATUM, CEREBRUM SUIS, GINKGO BILOBA, HELLEBORUS NIGER, HYPOTHALAMUS SUIS, HYOSCYAMUS NIGER, IODIUM, PHOSPHORUS, SACCHARUM OFFICINALE, SARCOLACTICUM ACID, SILICEA, TARENTULA HISPANA, VERATRUM ALBUM	Deseret Biologicals, Inc.	e014e6b6-a07a-4170-b9af-f477da71597d	2024-11-13	Warnings	Exact identifier unii: C151H8M554
Acetaminophen	ACETAMINOPHEN	Kroger Company	8fb19444-f0e0-4d26-81e8-6a4b835056d8	2024-11-12	Warnings	Exact identifier unii: 362O9ITL9D
equate pain reliever	ACETAMINOPHEN	WALMART INC.	59d01f72-4575-48e2-b914-b6a6456ca7d2	2024-11-11	Warnings	Exact identifier unii: 362O9ITL9D
DG Health Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Dolgencorp Inc	b33d104b-0b4d-40c6-8345-c2c740327331	2024-11-11	Warnings	Exact identifier unii: 362O9ITL9D
good sense night time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	L. Perrigo Company	89dc1423-d097-47a8-9025-eab5381cca26	2024-11-11	Warnings	Exact identifier unii: 362O9ITL9D
basic care nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	10f9627b-edda-422a-b01f-7066f9c98335	2024-11-11	Warnings	Exact identifier unii: 362O9ITL9D
nighttime severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	17c3fe42-3c40-4405-80b7-b3f9e4aa8376	2024-11-11	Warnings	Exact identifier unii: 362O9ITL9D
topcare nite time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	a7f9f1d0-7498-461c-b4e8-4c92cf3feae8	2024-11-11	Warnings	Exact identifier unii: 362O9ITL9D
nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Walgreen Company	bd079f5d-0a38-40e6-9661-e8236c88a24d	2024-11-11	Warnings	Exact identifier unii: 362O9ITL9D
basic care nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	624b8029-9fdb-4908-a13b-f9dd75030120	2024-11-11	Warnings	Exact identifier unii: 362O9ITL9D
foster and thrive nighttime severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Strategic Sourcing Services LLC	298b7754-d0d8-496d-9949-4c346cb11e34	2024-11-11	Warnings	Exact identifier unii: 362O9ITL9D
Duraflu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCL	Poly Pharmaceuticals, Inc.	55fffc1d-8449-4c28-a391-c6f60dd85622	2024-11-09	Warnings	Exact identifier unii: 362O9ITL9D
pain and fever	ACETAMINOPHEN	Kroger Company	d181560c-1c39-4f2e-8a17-996224ca040f	2024-11-09	Warnings	Exact identifier unii: 362O9ITL9D
SUDAFED PE Pressure Plus Pain	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	8538c291-9ce9-4866-b268-f4cbdb52f5bd	2024-11-08	Warnings	Exact identifier unii: 362O9ITL9D
Sudafed PE Sinus Pressure Plus Pain	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	60183922-bfd3-4377-884a-51b2f0a4c93a	2024-11-08	Warnings	Exact identifier unii: 362O9ITL9D
SUDAFED PE Head Congestion Plus Mucus	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	f0739186-41b9-4761-adf7-08101b30a18e	2024-11-08	Warnings	Exact identifier unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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