NDC 5011-308 - Hydroxyzine Hydrochloride

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: 5011-308
Manufacturer: RedPharm Drug Inc. | Pliva Inc.
Effective date: 2011-07-14
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
HYDROXYZINE HYDROCHLORIDE TABLETS USP	RedPharm Drug Inc. \| Pliva Inc.	2011-07-14	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROXYZINE HYDROCHLORIDE	ACTIVE INGREDIENT	76755771U3	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	1
HYDROXYZINE	ACTIVE MOIETY	30S50YM8OG	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	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 35 of 137 · 2,730 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Perfect Glow BB Cream Sunscreen SPF 30 - Medium	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	47320858-0aea-6ee9-e063-6294a90a9fa9	2025-12-30	Warnings	Exact identifier unii: 15FIX9V2JP
Perfect Glow BB Cream Sunscreen SPF 30 - Light Warm	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	47325530-b097-db9a-e063-6294a90a335d	2025-12-30	Warnings	Exact identifier unii: 15FIX9V2JP
Perfect Glow BB Cream Sunscreen SPF 30 - Tan	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	47328eb4-8ad7-28b5-e063-6294a90a20b1	2025-12-30	Warnings	Exact identifier unii: 15FIX9V2JP
Perfect Glow BB Cream Sunscreen SPF 30 - Tan Deep	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	4732bbec-d9f9-1639-e063-6394a90aff82	2025-12-30	Warnings	Exact identifier unii: 15FIX9V2JP
Perfect Glow BB Cream Sunscreen SPF 30 - Deep	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	4732ecd0-5261-7f11-e063-6394a90a26f3	2025-12-30	Warnings	Exact identifier unii: 15FIX9V2JP
ONETOOTHCLINIC TOOTH	SILICON DIOXIDE, TOCOPHEROL ACETATE, SODIUM PYROPHOSPHATE	CONE MEDICAL Co., Ltd.	9a567c9e-b8ce-7bf1-e053-2995a90aff2b	2025-12-30	Warnings	Exact identifier unii: ETJ7Z6XBU4
ONETOOTH CLINIC TOOTH	SILICON DIOXIDE, TOCOPHEROL ACETATE, TETRASODIUM PYROPHOSPHATE	CONE MEDICAL Co., Ltd.	bd50abcd-8a85-2923-e053-2995a90a109b	2025-12-30	Warnings	Exact identifier unii: ETJ7Z6XBU4
Ageless Glow Serum BB Cream Sunscreen SPF 40 - Fair	HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	473738b4-7c36-8edf-e063-6394a90ad24b	2025-12-30	Warnings	Exact identifier unii: 15FIX9V2JP
Ageless Glow Serum BB Cream Sunscreen SPF 40 - Medium Tan	HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	47387d5f-e77b-5633-e063-6294a90a5584	2025-12-30	Warnings	Exact identifier unii: 15FIX9V2JP
Ageless Glow Serum BB Cream Sunscreen SPF 40 - Tan	HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	4738be66-0fe8-148e-e063-6394a90a1b02	2025-12-30	Warnings	Exact identifier unii: 15FIX9V2JP
Ageless Glow Serum BB Cream Sunscreen SPF 40 - Tan Deep	HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	4738eed1-9f72-5fd8-e063-6394a90a26bd	2025-12-30	Warnings	Exact identifier unii: 15FIX9V2JP
Ageless Glow Serum BB Cream Sunscreen SPF 40 - Deep	HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	4739179e-88b3-8820-e063-6394a90aa211	2025-12-30	Warnings	Exact identifier unii: 15FIX9V2JP
Discount Drug Mart Eye Drops Dry Eye Relief	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Discount Drug Mart	f7fd53be-e501-d97f-e053-6394a90ad409	2025-12-30	Warnings	Exact identifier unii: 3NXW29V3WO
Exchange Select Artificial Tears Lubricant Eye Drops	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Army and Air Force Exchange Service	9e478343-8ae7-823e-e053-2995a90a84ed	2025-12-30	Warnings	Exact identifier unii: 3NXW29V3WO
DG Health Dry Eye Relief	GLYCERIN, HYPROMELLOSE, POLYPROPYLENE GLYCOL 400	Dolgencorp LLC	9cb20c3b-bf6d-8c7c-e053-2995a90aa485	2025-12-30	Warnings	Exact identifier unii: 3NXW29V3WO
Core Values Eye Drops Dry Eye Relief	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Liberty Procurement Co. Inc.	f8285f68-c40c-19a8-e053-6394a90aacad	2025-12-30	Warnings	Exact identifier unii: 3NXW29V3WO
Harris Teeter Eye Drops Artificial Tears	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Harris Teeter, LLC.	f82957d9-c4ad-a914-e053-6294a90aac50	2025-12-30	Warnings	Exact identifier unii: 3NXW29V3WO
CVS Gentle Tears	DEXTRAN 70, HYPROMELLOSE	CVS Pharmacy, Inc.	9b1ea0eb-c34f-6603-e053-2995a90a6a95	2025-12-30	Warnings	Exact identifier unii: 3NXW29V3WO
SPF 30 Sunscreen	ZINC OXIDE, TITANIUM DIOXIDE	CLEURE	f5512f34-08ee-b0f6-e053-2a95a90ab5bd	2025-12-29	Warnings	Exact identifier unii: 15FIX9V2JP
RE-NUTRIV ULTRA RADIANCE MAKEUP BROAD SPECTRUM SPF 20	OCTINOXATE AND TITANIUM DIOXIDE	ESTEE LAUDER INC	897b8edb-f089-4a49-baca-e05806b0a068	2025-12-29	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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