NDC 0049-5620 - Atarax

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: 0049-5620
Package NDCs from labels: 0049-5620-66
Manufacturer: Roerig
Effective date: 2006-06-20
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Atarax - Roerig	Roerig	2006-06-20	HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0049-5620-66	Atarax	100 in 1 BOTTLE	TABLET	100		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0049-5620	ATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]	1	1 package rows	20060921_7EAF5043-5C73-47AF-904B-8E1FAE02AF2E.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
hydroxyzine hydrochloride	ACTIVE INGREDIENT	76755771U3	ATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]	1
hydroxyzine	ACTIVE MOIETY	30S50YM8OG	ATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]	1
acacia	INACTIVE INGREDIENT		ATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]	1
alcohol	INACTIVE INGREDIENT	3K9958V90M	ATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]	1
alginic acid	INACTIVE INGREDIENT		ATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]	1
Blue 1	INACTIVE INGREDIENT		ATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]	1
carnauba wax	INACTIVE INGREDIENT		ATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]	1
dibasic calcium phosphate	INACTIVE INGREDIENT		ATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]	1
gelatin	INACTIVE INGREDIENT		ATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]	1
lactose	INACTIVE INGREDIENT		ATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	ATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]	1
menthol	INACTIVE INGREDIENT	80R52064AQ	ATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]	1
peppermint oil	INACTIVE INGREDIENT		ATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]	1
polyethylene glycol	INACTIVE INGREDIENT		ATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]	1
precipitated calcium carbonate	INACTIVE INGREDIENT		ATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]	1
Red 3	INACTIVE INGREDIENT		ATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]	1
shellac	INACTIVE INGREDIENT		ATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]	1
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	ATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]	1
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	ATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]	1
spearmint oil	INACTIVE INGREDIENT		ATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]	1
starch	INACTIVE INGREDIENT		ATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]	1
sucrose	INACTIVE INGREDIENT	C151H8M554	ATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	ATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	ATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]	1
velo dark green	INACTIVE INGREDIENT		ATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]	1
velo yellow	INACTIVE INGREDIENT		ATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]	1
water	INACTIVE INGREDIENT	059QF0KO0R	ATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]	1
white wax	INACTIVE INGREDIENT		ATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]	1
Yellow 6 Lake	INACTIVE INGREDIENT		ATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]	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 4 of 8 · 141 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	cc6a12ed-411b-4b0c-8108-58ef7db8da55	2025-10-15	Warnings, Adverse reactions	Exact identifier rxcui: 995258
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	eef36dab-c318-44d2-8583-7bae3bfceee7	2025-10-13	Warnings, Adverse reactions	Exact identifier rxcui: 995258
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	Direct Rx	d956063a-ef48-faca-e053-2995a90a0291	2025-10-06		Exact identifier rxcui: 995218
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	American Health Packaging	fc148d96-b868-4e45-b7d2-977faf431049	2025-09-15	Warnings, Adverse reactions	Exact identifier rxcui: 995281
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	93d117dd-e2bf-4daa-abe3-d4fefed3313c	2025-09-11	Warnings, Adverse reactions	Exact identifier rxcui: 995218 rxcui: 995281 rxcui: 995258
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	3f90259a-a684-498f-8963-d02eaba2e9db	2025-09-08	Warnings, Adverse reactions	Exact identifier rxcui: 995258
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	9c2c05e0-b123-4ddf-8b07-6bb3ca0678b5	2025-09-08	Warnings, Adverse reactions	Exact identifier rxcui: 995218
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	2b05bd0e-af57-4e74-92f8-a4311330142f	2025-08-18	Warnings, Adverse reactions	Exact identifier rxcui: 995258
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	214b3f14-2f6c-4f36-b7a6-e0b1f820e3a7	2025-08-18	Warnings, Adverse reactions	Exact identifier rxcui: 995281
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	6a1a48ac-8ad5-4363-b298-d9825ae2a448	2025-08-14	Warnings, Adverse reactions	Exact identifier rxcui: 995218 rxcui: 995281 rxcui: 995258
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	80309ec1-e5d5-4454-b8ce-67d7e6805e44	2025-07-31	Warnings, Adverse reactions	Exact identifier rxcui: 995218 rxcui: 995281 rxcui: 995258
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE ORAL	Bionpharma Inc.	39f93633-000e-6c3f-e063-6394a90a5a0b	2025-07-15	Warnings, Adverse reactions	Exact identifier rxcui: 995241
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	ca015a35-1f94-4f92-9143-3f149982d316	2025-07-15	Warnings, Adverse reactions	Exact identifier rxcui: 995281
HydrOXYzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	723b810b-46cc-4c45-ae1f-93ca358e007d	2025-07-09	Warnings, Adverse reactions	Exact identifier rxcui: 995258
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	2fc9b08a-e675-dbc5-e063-6294a90ad054	2025-07-02	Warnings, Adverse reactions	Exact identifier rxcui: 995218 rxcui: 995281 rxcui: 995258
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	e4c60e14-28c7-46e2-9fdc-b1a1ce54f3c2	2025-06-27	Warnings, Adverse reactions	Exact identifier rxcui: 995258
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	44c63e67-a9e0-4a4f-b34e-2ca60a981766	2025-06-20	Warnings, Adverse reactions	Exact identifier rxcui: 995281
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	6577589f-1a80-41d8-847a-70c3f38d8dc0	2025-06-02	Warnings, Adverse reactions	Exact identifier rxcui: 995218
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	2a343906-0bea-4bd8-bd35-c3f199d9b266	2025-05-30	Warnings, Adverse reactions	Exact identifier rxcui: 995241
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	e4e6a91d-f10b-4d85-a526-4c6192ea85dc	2025-05-23	Warnings, Adverse reactions	Exact identifier rxcui: 995258

Reported adverse events (FAERS/openFDA)#

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