NDC 0591-5726-01 - Hydroxyzine Pamoate

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: 0591-5726
Requested NDC: 0591-5726-01
Package NDCs from labels: 0591-5726-01, 0591-5726-05
Manufacturer: Watson Labs
Effective date: 2007-01-01
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Hydroxyzine Pamoate - Watson Labs	Watson Labs	2007-01-01	HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0591-5726-01	Hydroxyzine Pamoate	100 in 1 BOTTLE	CAPSULE	100		1
0591-5726-05	Hydroxyzine Pamoate	500 in 1 BOTTLE	CAPSULE	500		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-5726	HYDROXYZINE PAMOATE (HYDROXYZINE PAMOATE) CAPSULE [WATSON LABS]	1	2 package rows	20070111_A6EDD742-30B1-4427-BCA8-A81F7EBB2BC6.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Hydroxyzine Pamoate	ACTIVE INGREDIENT	M20215MUFR	HYDROXYZINE PAMOATE (HYDROXYZINE PAMOATE) CAPSULE [WATSON LABS]	1
Hydroxyzine	ACTIVE MOIETY	30S50YM8OG	HYDROXYZINE PAMOATE (HYDROXYZINE PAMOATE) CAPSULE [WATSON LABS]	1
D & C Yellow No.10	INACTIVE INGREDIENT		HYDROXYZINE PAMOATE (HYDROXYZINE PAMOATE) CAPSULE [WATSON LABS]	1
docusate sodium	INACTIVE INGREDIENT	F05Q2T2JA0	HYDROXYZINE PAMOATE (HYDROXYZINE PAMOATE) CAPSULE [WATSON LABS]	1
FD & C Green No. 3	INACTIVE INGREDIENT		HYDROXYZINE PAMOATE (HYDROXYZINE PAMOATE) CAPSULE [WATSON LABS]	1
gelatin	INACTIVE INGREDIENT	2G86QN327L	HYDROXYZINE PAMOATE (HYDROXYZINE PAMOATE) CAPSULE [WATSON LABS]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	HYDROXYZINE PAMOATE (HYDROXYZINE PAMOATE) CAPSULE [WATSON LABS]	1
microcrystalline cellulose	INACTIVE INGREDIENT		HYDROXYZINE PAMOATE (HYDROXYZINE PAMOATE) CAPSULE [WATSON LABS]	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROXYZINE PAMOATE (HYDROXYZINE PAMOATE) CAPSULE [WATSON LABS]	1
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	HYDROXYZINE PAMOATE (HYDROXYZINE PAMOATE) CAPSULE [WATSON LABS]	1
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	HYDROXYZINE PAMOATE (HYDROXYZINE PAMOATE) CAPSULE [WATSON LABS]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	HYDROXYZINE PAMOATE (HYDROXYZINE PAMOATE) CAPSULE [WATSON LABS]	1

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 2 of 3 · 51 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Preferred Pharmaceuticals Inc.	54af47cd-65c2-4bc9-95cd-7883e56ed035	2025-06-27	Warnings, Adverse reactions	Exact identifier rxcui: 995253
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Preferred Pharmaceuticals, Inc.	2a66117a-fcd4-4094-927c-3a7699ef9660	2025-06-27	Warnings, Adverse reactions	Exact identifier rxcui: 995253
hydroxyzine pamoate	HYDROXYZINE PAMOATE	NuCare Pharmaceuticals,Inc.	aee7c4a8-10cb-2107-e053-2995a90a90e7	2025-06-04	Warnings, Adverse reactions	Exact identifier rxcui: 995253
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Bryant Ranch Prepack	34f7e401-9b2c-7d63-e063-6394a90a1f00	2025-05-12	Warnings, Adverse reactions	Exact identifier rxcui: 995253
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Aphena Pharma Solutions - Tennessee, LLC	308cd178-a9d2-3132-e063-6394a90a7357	2025-04-28	Warnings, Adverse reactions	Exact identifier rxcui: 995253
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Asclemed USA, Inc.	82187031-779e-47bc-943c-eb1a1ef30a7a	2025-02-17	Warnings, Adverse reactions	Exact identifier rxcui: 995253
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Bryant Ranch Prepack	f74e4b3e-992c-402d-92b8-258fccb42b64	2025-02-10	Warnings, Adverse reactions	Exact identifier rxcui: 995253
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Direct_Rx	8c395a13-9da3-7b77-e053-2995a90a1916	2025-01-22	Warnings, Adverse reactions	Exact identifier rxcui: 995253
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Bryant Ranch Prepack	02616eee-a1a4-4afc-b84e-69fd28755138	2024-12-16	Warnings, Adverse reactions	Exact identifier rxcui: 995253
hydroxyzine pamoate	HYDROXYZINE PAMOATE	NuCare Pharmaceutcals, Inc.	2879c79f-bf2f-0bc9-e063-6394a90a98ae	2024-12-04	Warnings, Adverse reactions	Exact identifier rxcui: 995253
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	American Health Packaging	e1a7d95c-e6f6-4a89-90b0-002156e90b41	2024-11-21	Warnings, Adverse reactions	Exact identifier rxcui: 995253
hydroxyzine pamoate	HYDROXYZINE PAMOATE	A-S Medication Solutions	a31271f0-ac60-4fda-b1f5-ddf7241c8a0e	2024-10-09	Warnings, Adverse reactions	Exact identifier rxcui: 995253
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Bryant Ranch Prepack	fac2df9d-d395-4b07-b299-2ed946441b22	2024-10-04	Warnings, Adverse reactions	Exact identifier rxcui: 995253
hydroxyzine pamoate	HYDROXYZINE PAMOATE	NuCare Pharmaceuticals,Inc.	8cb94f1d-1e45-531a-e053-2a95a90a1ba0	2024-06-18	Warnings, Adverse reactions	Exact identifier rxcui: 995253
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	NuCare Pharmaceuticals,Inc.	8a8416f8-18ce-99e6-e053-2995a90a1045	2024-06-14	Warnings, Adverse reactions	Exact identifier rxcui: 995253
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Pharmasource Meds, LLC	f563aa1a-1e21-49d4-e053-2a95a90a3264	2024-05-28	Warnings, Adverse reactions	Exact identifier rxcui: 995253
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Aphena Pharma Solutions - Tennessee, LLC	78005ad7-290c-4716-937f-f0ec82f4e607	2024-02-06	Warnings, Adverse reactions	Exact identifier rxcui: 995253
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Aphena Pharma Solutions - Tennessee, LLC	c29f005e-ae75-415d-9fd6-591f074dcda5	2023-11-15	Warnings, Adverse reactions	Exact identifier rxcui: 995253
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	A-S Medication Solutions	42186eab-89d1-4963-bfd8-087b3024af33	2023-11-08	Warnings, Adverse reactions	Exact identifier rxcui: 995253
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Bryant Ranch Prepack	ea1c7326-52ea-4934-844c-892d868042cf	2023-10-25	Warnings, Adverse reactions	Exact identifier rxcui: 995253

Reported adverse events (FAERS/openFDA)#

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