NDC 16714-082-06 - 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: 16714-082
Requested NDC: 16714-082-06
Package NDCs from labels: 16714-082-10, 16714-082-11, 16714-082-12, 16714-082-06
Manufacturer: NuCare Pharmaceuticals,Inc.
Effective date: 2026-10-09
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Rx Only	NuCare Pharmaceuticals,Inc.	2026-10-09	HUMAN PRESCRIPTION DRUG LABEL
HydrOXYzine Hydrochloride - Northstar RxLLC \| Piramal Pharma Limited	Northstar RxLLC \| Piramal Pharma Limited	2025-12-23	Human Prescription Drug Label
HydrOXYzine Hydrochloride - A-S Medication Solutions	A-S Medication Solutions	2025-07-09	Human Prescription Drug Label
Rx Only	NuCare Pharmaceuticals,Inc.	2025-02-05	HUMAN PRESCRIPTION DRUG LABEL
Rx Only	McKesson Corporation dba SKY Packaging \| Legacy Pharmaceutical Packaging, LLC	2024-12-26	HUMAN PRESCRIPTION DRUG LABEL
HydrOXYzine Hydrochloride - A-S Medication Solutions	A-S Medication Solutions	2023-09-07	Human Prescription Drug Label
HydrOXYzine Hydrochloride - A-S Medication Solutions	A-S Medication Solutions	2023-09-07	Human Prescription Drug Label
HydrOXYzine Hydrochloride - Aphena Pharma Solutions - Tennessee, LLC	Aphena Pharma Solutions - Tennessee, LLC	2023-01-23	Human Prescription Drug Label
HydrOXYzine Hydrochloride - Denton Pharma, Inc. DBA Northwind Pharmaceuticals	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2021-01-14	HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2012-07-24	Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
16714-082-10	HydrOXYzine Hydrochloride	100 in 1 BOTTLE	TABLET	100	19
16714-082-11	HydrOXYzine Hydrochloride	500 in 1 BOTTLE	TABLET	500	19
16714-082-12	HydrOXYzine Hydrochloride	1000 in 1 BOTTLE	TABLET	1000	19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-082	HYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]	18	Current NDC, Legacy NDC, 3 package rows	20250206_8e5fce17-936e-46ea-a969-518c952c2091.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-082-04	EA - Each	16714-082	da8db88e-e5d7-4f30-8258-be17f1111a82	1	2012-07-24
16714-082-05	EA - Each	16714-082	7f3cf018-8c9b-4d7c-9859-6606747dfb34	1	2012-07-24
16714-082-06	EA - Each	16714-082	452fbb51-342a-45c5-82ee-7dd64e6d9904	1	2012-07-24
16714-082-10	EA - Each	16714-082	8abc36ef-c58f-463d-8842-61daa04d62a9	1	2013-10-17
16714-082-11	EA - Each	16714-082	85511cb8-8dbe-4016-89b7-205295aab376	1	2013-10-17
16714-082-12	EA - Each	16714-082	a9e82ee8-4558-4c67-a40b-bf0bcb93eb7e	1	2013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HydrOXYzine Hydrochloride	ACTIVE INGREDIENT	76755771U3	HYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]	10
hydrOXYzine	ACTIVE MOIETY	30S50YM8OG	HYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]	10
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	HYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]	10
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]	10
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	HYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]	10
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	HYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]	10
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	HYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]	10
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	HYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]	10
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]	10
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	HYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]	10
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]	10
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]	10
HydrOXYzine Hydrochloride	ACTIVE INGREDIENT	76755771U3	HYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	3
hydrOXYzine	ACTIVE MOIETY	30S50YM8OG	HYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	3
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	HYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	HYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	HYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	3
POLYETHYLENE GLYCOL 1000	INACTIVE INGREDIENT	U076Q6Q621	HYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	HYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	HYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	3

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 145 · 2,898 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Muscle Ice	PHYTOLACCA DECANDRA, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, MAGNESIA PHOSPHORICA, SILICEA, MENTHOL (CRYSTALS)	Peaceful Mountain, Inc.	03b6e2a9-f335-4ae2-9011-80bd019afb72	2026-07-30	Warnings	Exact identifier unii: ETJ7Z6XBU4
Bioplasma	SILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDE	Hyland's Inc.	dd0a7ed2-d112-4b96-e053-2995a90ac6b6	2026-07-30	Warnings	Exact identifier unii: ETJ7Z6XBU4
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	St Mary's Medical Park Pharmacy	9ef6a4b7-362d-61b4-e053-2995a90a0ebb	2026-07-28	Warnings, Adverse reactions	Exact identifier rxcui: 995218 unii: 76755771U3
HydrOXYzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	5dea636d-dee6-47d4-b83c-b9f0c0b1b6ca	2026-07-24	Warnings, Adverse reactions	Exact identifier application number: ANDA040840 rxcui: 995218 unii: 76755771U3
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-C	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	BEL STAR S.A.	575fb2c3-e332-8a3b-e063-6394a90a9fd9	2026-07-24	Warnings	Exact identifier unii: 15FIX9V2JP
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	30b6f7b3-b620-961a-e063-6394a90a487b	2026-07-23	Warnings, Adverse reactions	Exact identifier rxcui: 995258 unii: 76755771U3
True Coast SPF 50 Mineral Sunscreen	ZINC OXIDE 18%, TITANIUM DIOXIDE 6%	Foshan Sugar Max Cosmetics CO.,Ltd	5379466d-8d14-5fc2-e063-6394a90abd7e	2026-07-22	Warnings	Exact identifier unii: 15FIX9V2JP
Droptics Dry Eye Relief	CARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80	Droptics LLC	29d7614b-f4b7-48e2-97c5-d1bff27731d2	2026-07-22	Warnings	Exact identifier unii: 6OZP39ZG8H
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte Foundation	OCTINOXATE AND TITANIUM DIOXIDE	SICOS ET CIE	571f23e9-1126-e32d-e063-6294a90a9951	2026-07-21	Warnings	Exact identifier unii: 15FIX9V2JP
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	APOZEAL PHARMACEUTICALS INC	87d4bbff-0498-4c26-86cb-7ce173afa0b6	2026-07-21	Warnings, Adverse reactions	Exact identifier unii: 76755771U3
HydrOXYzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	be6a2f09-c0f3-44e2-aac3-37e3702b93f0	2026-07-21	Warnings, Adverse reactions	Exact identifier application number: ANDA040840 rxcui: 995281 unii: 76755771U3
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Cardinal Health 107, LLC	b4d274ce-d616-4835-80ce-76270524ed36	2026-07-20	Warnings, Adverse reactions	Exact identifier rxcui: 995258 unii: 76755771U3
MENS SPF50 ALL IN ONE SUNSCREEN	MENS SPF50 ALL IN ONE SUNSCREEN	Lance (Guangzhou) Biological Technology Co., Ltd.	57074480-77fd-cc06-e063-6294a90a28d4	2026-07-20	Warnings	Exact identifier unii: 15FIX9V2JP
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte Foundation	OCTINOXATE AND TITANIUM DIOXIDE	L'Oreal USA Products Inc	5711364c-f9b4-bfa6-e063-6294a90ace4a	2026-07-20	Warnings	Exact identifier unii: 15FIX9V2JP
Prid	ICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFUR	Hyland's Inc.	49689eeb-7790-07f1-e063-6294a90a2df2	2026-07-16	Warnings	Exact identifier unii: ETJ7Z6XBU4
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Major Pharmaceuticals	7f76580c-96a0-4b56-8986-ff5488bb9869	2026-07-15	Warnings, Adverse reactions	Exact identifier rxcui: 995218 rxcui: 995281 rxcui: 995258 unii: 76755771U3
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	REMEDYREPACK INC.	bb4a7d22-2f42-4e9f-bf98-cee43ed14d50	2026-07-15	Warnings, Adverse reactions	Exact identifier rxcui: 995281 unii: 76755771U3
Leg Cramps PM	OYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFUR	Hyland's Inc.	b0574a7e-88fa-417e-b6d5-60ced59eba47	2026-07-15	Warnings	Exact identifier unii: ETJ7Z6XBU4
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc	c8b441bf-a03e-47b3-8f06-c347f5ca4b70	2026-07-15	Warnings, Adverse reactions	Exact identifier rxcui: 995218 unii: 76755771U3
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	REMEDYREPACK INC.	b6189074-e199-4f58-a78d-c04f131c13d9	2026-07-10	Warnings, Adverse reactions	Exact identifier rxcui: 995258 unii: 76755771U3

Reported adverse events (FAERS/openFDA)#

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