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 122 of 181 · 3,613 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
equate pain reliever	ACETAMINOPHEN	WALMART INC.	4518fe82-3ba8-4e9e-a036-776df7fb8d57	2024-11-21	Warnings	Exact identifier unii: 362O9ITL9D
DayTime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	5b55d1df-275b-40d8-bde3-fc43313b7eb3	2024-11-20	Warnings	Exact identifier unii: 362O9ITL9D
Mejoralito	ACETAMINOPHEN	OPMX Chula Vista	fd2ecde0-296e-060f-e053-6294a90afd98	2024-11-15	Warnings	Exact identifier unii: 362O9ITL9D
Temp X	ACETAMINOPHEN	OPMX Chula Vista	fd2edc32-0351-c991-e053-6294a90ab4ce	2024-11-15	Warnings	Exact identifier unii: 362O9ITL9D
CVS Health Extra Strength Antacid and Pain Reliever	ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE	CVS Pharmacy	afe9e755-18ba-305f-e053-2995a90aa8d0	2024-11-14	Warnings	Exact identifier unii: XF417D3PSL
Tylenol 8 HR Arthritis Pain	ACETAMINOPHEN	Kenvue Brands LLC	3af22fc8-e4e0-4863-8696-6bc1257047cb	2024-11-13	Warnings	Exact identifier unii: 362O9ITL9D
Sodium Citrate and Citric Acid	SODIUM CITRATE AND CITRIC ACID MONOHYDRATE	Pharmaceutical Associates, Inc.	63201a61-6ac5-41ae-8b2d-ff0d3a8ddfd5	2024-11-13	Adverse reactions	Exact identifier unii: XF417D3PSL
Walgreens Effervescent Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Walgreens	667418fc-a3ab-cbc7-e053-2a91aa0a2023	2024-11-13	Warnings	Exact identifier unii: XF417D3PSL
Up and Up Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Target Corporation	a72eef45-b985-638a-e053-2995a90aa20a	2024-11-13	Warnings	Exact identifier unii: XF417D3PSL
Signature Care Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Safeway, Inc	6e120024-475a-73af-e053-2a91aa0a42a6	2024-11-13	Warnings, Adverse reactions	Exact identifier unii: XF417D3PSL
Kroger Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Kroger Company	6d858b0e-a3c8-2686-e053-2991aa0acc06	2024-11-13	Warnings	Exact identifier unii: XF417D3PSL
TopCare Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Topco Associates LLC	639f9d57-f26a-708a-e053-2a91aa0a6962	2024-11-13	Warnings, Adverse reactions	Exact identifier unii: XF417D3PSL
Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	H. E. Butt Grocery Company	6418cde9-607b-4ca1-e053-2991aa0a9170	2024-11-13	Warnings	Exact identifier unii: XF417D3PSL
Bromo Seltzer	ASPIRIN, SODIUM BICARBONATE, CITRIC ACID	Tower Laboratories Ltd	8ff88ee1-e33e-4051-992f-24e2720c48ce	2024-11-13	Warnings	Exact identifier unii: XF417D3PSL
Care One Original Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Foodhold U.S.A.	8f662c51-d2fa-6458-e053-2995a90ac6fd	2024-11-13	Warnings	Exact identifier unii: XF417D3PSL
Top Value Effervescent Pain Relief	APIRIN, CITRIC ACID, SODIUM BICARBONATE	Tower Laboratories Ltd	43c7f435-735c-3fab-e054-00144ff88e88	2024-11-13	Warnings, Adverse reactions	Exact identifier unii: XF417D3PSL
DG Health Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	DOLGENCORP, INC	8f1343d5-2884-3a14-e053-2a95a90a2f90	2024-11-13	Warnings	Exact identifier unii: XF417D3PSL
Good Sense Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Good Sense	cd25b0c3-0134-beef-e053-2a95a90a092b	2024-11-13	Warnings	Exact identifier unii: XF417D3PSL
Drug Mart Effervescent Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Discount Drug Mart, Inc	8bc65603-1dbf-30ab-e053-2995a90a7c15	2024-11-13	Warnings	Exact identifier unii: XF417D3PSL
Best Choice Effervescent Antacid Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Valu Merchandisers Company	8aab905b-5fe7-dddb-e053-2995a90a6c6f	2024-11-13	Warnings	Exact identifier unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

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