NDC 0049-5610 - 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: 0049-5610
Package NDCs from labels: 0049-5610-66, 0049-5610-73
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
0049-5610-66	Atarax	100 in 1 BOTTLE	TABLET	100		1
0049-5610-73	Atarax	500 in 1 BOTTLE	TABLET	500		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0049-5610	ATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]	1	2 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 5 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	Bryant Ranch Prepack	a8c83479-f919-49f9-b125-747bd0e3211c	2025-05-23	Warnings, Adverse reactions	Exact identifier rxcui: 995281
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	7c959515-a5a9-4d5e-90e9-bd58bc947330	2025-05-23	Warnings, Adverse reactions	Exact identifier rxcui: 995218
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	f9ff4b7c-dc81-47af-8371-5c681eb0d876	2025-05-16	Warnings, Adverse reactions	Exact identifier rxcui: 995218 rxcui: 995281 rxcui: 995258
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	b52e1759-8be3-4e46-a891-4eaa9270c421	2025-05-15	Warnings, Adverse reactions	Exact identifier rxcui: 995218 rxcui: 995258
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	ATLANTIC BIOLOGICALS CORP.	a2fbc502-6ca3-4304-9069-b7249c9d9489	2025-05-12	Warnings, Adverse reactions	Exact identifier rxcui: 995241
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	5ff091be-6e30-4305-a172-769ee45e110b	2025-04-02	Warnings, Adverse reactions	Exact identifier rxcui: 995281
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	dd9e5dc5-720c-4de8-abae-6404c31f341f	2025-03-31	Warnings, Adverse reactions	Exact identifier rxcui: 995218
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	d03fdfd0-5dbd-40fe-a6e3-082a47751c2c	2025-03-31	Warnings, Adverse reactions	Exact identifier rxcui: 995258
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	0c687cbe-ce40-4bc0-b880-5166b5be7a80	2025-03-20	Warnings, Adverse reactions	Exact identifier rxcui: 995218 rxcui: 995281 rxcui: 995258
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	Marlex Pharmaceuticals, Inc.	31a907e6-7fae-0682-e063-6294a90a24a5	2025-03-01	Warnings, Adverse reactions	Exact identifier rxcui: 995218 rxcui: 995281 rxcui: 995258
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	ANI Pharmaceuticals, Inc.	43889411-a303-41a1-b03b-1ee46f452c54	2025-02-11	Warnings, Adverse reactions	Exact identifier rxcui: 995241
HydrOXYzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	ffd33207-3f35-3486-e053-6394a90ac0ae	2025-02-05	Warnings, Adverse reactions	Exact identifier rxcui: 995258
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Epic Pharma, LLC	82b015dc-999c-46a4-bcaa-a4c81a193b68	2025-01-31	Warnings, Adverse reactions	Exact identifier rxcui: 995218 rxcui: 995281 rxcui: 995258
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	09092888-0c18-501d-e063-6294a90aad67	2024-12-31	Warnings, Adverse reactions	Exact identifier rxcui: 995258
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Asclemed USA, Inc.	4f3266f4-00a6-4c0c-bff2-e606913de894	2024-12-17	Warnings, Adverse reactions	Exact identifier rxcui: 995218 rxcui: 995281 rxcui: 995258
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	Sunrise Pharmaceutical, Inc.	94561525-a565-4193-b64d-e1459ab05678	2024-12-09	Warnings, Adverse reactions	Exact identifier rxcui: 995218 rxcui: 995281 rxcui: 995258
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Chartwell RX, LLC	934afb42-fee8-415b-8090-2265bb299afe	2024-10-28	Warnings, Adverse reactions	Exact identifier rxcui: 995218 rxcui: 995281 rxcui: 995258
Hydroxyzine Hydrochloride	HYDROXYZINE	Amneal Pharmaceuticals LLC	89901966-724b-4773-98b8-ea663ceabd53	2024-10-25	Warnings, Adverse reactions	Exact identifier rxcui: 995218 rxcui: 995281 rxcui: 995258
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	Chartwell RX, LLC	53b2d731-f38a-47c0-9e5c-abd3b45e2fe1	2024-10-22	Warnings, Adverse reactions	Exact identifier rxcui: 995241
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	99995bdb-a35f-7753-e053-2995a90a683c	2024-10-15	Warnings, Adverse reactions	Exact identifier rxcui: 995281

Reported adverse events (FAERS/openFDA)#

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