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 7 of 145 · 2,898 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Creamy Beige Perfecting Makeup Broad Spectrum SPF 25	OCTINOXATE, TITANIUM DIOXIDE	Merle Norman Cosmetics, Inc	548b7c90-ef97-38ab-e063-6394a90ac609	2026-06-18	Warnings	Exact identifier unii: 15FIX9V2JP
GlowBiotics Tinted Sunscreen SPF 30	ZINC OXIDE	Rum Brands, LLC	544dba29-4785-4ab6-e063-6394a90a17b3	2026-06-16	Warnings	Exact identifier unii: 15FIX9V2JP
Societe Prime and Defend	ZINC OXIDE SUNSCREEN	Societe Clinical Skincare	5439bd31-5ee1-9bca-e063-6394a90a748c	2026-06-16	Warnings	Exact identifier unii: 15FIX9V2JP
Societe CoverShield Tinted SPF	ZINC OXIDE	Societe Clinical Skincare	545efbc4-82d4-f126-e063-6294a90a9710	2026-06-16	Warnings	Exact identifier unii: 15FIX9V2JP
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Saptalis Pharmaceuticals, LLC.	9ab23881-334c-474d-9d93-25ea225548dc	2026-06-16	Warnings, Adverse reactions	Exact identifier unii: 76755771U3
H-Scars Formula	CALENDULA OFFICINALLIS, SILICEA	Healing Natural Oils LLC	8433ff00-d815-45e0-b0ec-1448668dd8f8	2026-06-16	Warnings	Exact identifier unii: ETJ7Z6XBU4
E-Z-GAS II	ANTACID/ANTIFLATULENT	E-Z-EM, INC.	4e12e1cb-b033-076d-e054-00144ff8d46c	2026-06-15	Warnings	Exact identifier unii: ETJ7Z6XBU4
Shield by HEALTHY SKIN LAB MD SUNSCREEN	TITANIUM DIOXIDE, ZINC OXIDE	HEALTHY SKIN LAB LIMITED	6838b754-9915-48ff-af35-5338dbd06ac4	2026-06-15	Warnings	Exact identifier unii: 15FIX9V2JP
BM BIO28 ALCOHOL	CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEA	Total Operations Management LLC DBA:Bestmade Natural Products Micro	544b66c4-49df-556f-e063-6394a90af3ed	2026-06-15	Warnings	Exact identifier unii: ETJ7Z6XBU4
SFL SUNSCREEN - SOL DEFENSE SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Lifeline Medical, Inc	5438c185-31c9-c51e-e063-6394a90ae9ef	2026-06-14	Warnings	Exact identifier unii: 15FIX9V2JP
BM Tooth Remineralization	CALC PHOS, CALC FLUOR, SILICEA	Total Operations Management LLC DBA:Bestmade Natural Products Micro	543bc298-ec32-38e9-e063-6394a90aac15	2026-06-14	Warnings	Exact identifier unii: ETJ7Z6XBU4
Nail Fungus Control Extra Strength	CALENDULA OFFICINALIS FLOWERING TOP, SILICON DIOXIDE, AND HYPERICUM PERFORATUM	Forces of Nature	d02b88a6-1999-4dcd-91b5-fad88a664fcb	2026-06-14	Warnings	Exact identifier unii: ETJ7Z6XBU4
Nerve Pain	ARABICA COFFEE BEAN, SILICON DIOXIDE, AND HYPERICUM PERFORATUM	Forces of Nature	a9c3ba2e-9254-4ccd-9fe9-7a360fdf2bb7	2026-06-14	Warnings	Exact identifier unii: ETJ7Z6XBU4
Scar Control	CALENDULA OFFICINALIS FLOWERING TOP, ALLYLTHIOUREA, AND SILICON DIOXIDE	Forces of Nature	595c3423-6b52-48fc-8a95-00b53c1ecc7b	2026-06-14	Warnings	Exact identifier unii: ETJ7Z6XBU4
BM BM186 DROPS	ARNICA, FERR PHOS, HYPERICUM, IGNATIA, SILICA	Total Operations Management LLC DBA:Bestmade Natural Products Micro	54243745-bd67-19c1-e063-6394a90a4b72	2026-06-13	Warnings	Exact identifier unii: ETJ7Z6XBU4
BM BM186 DROPS	ARNICA, FERR PHOS, HYPERICUM, IGNATIA, SILICA	BM Private Limited	540d8fbe-3bdb-1b54-e063-6394a90a114d	2026-06-12	Warnings	Exact identifier unii: ETJ7Z6XBU4
BM BM5 DROPS	APIS MELL, BAPTISIA, CONIUM MAC, ECHINACEA, EUPATORIUM PERF, SILICEA, THUJA OCC	Total Operations Management LLC DBA:Bestmade Natural Products Micro	540e4ee3-596f-4cea-e063-6294a90a6a60	2026-06-12	Warnings	Exact identifier unii: ETJ7Z6XBU4
Sunbetter Daily Mineral Protection Broad Spectrum SPF 75 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	SKINBETTER SCIENCE LLC	54106748-9810-d3ff-e063-6394a90a5b7a	2026-06-12	Warnings	Exact identifier unii: 15FIX9V2JP
Sunbetter Daily Mineral Protection Broad Spectrum SPF 70 Sheer Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	SKINBETTER SCIENCE LLC	5410e0ed-aed5-3279-e063-6294a90a0c3e	2026-06-12	Warnings	Exact identifier unii: 15FIX9V2JP
Visine Red Eye Total Comfort Multi-Symptom	TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, AND ZINC SULFATE, UNSPECIFIED FORM	Kenvue Brands LLC	5747edef-7a87-41d7-9594-6c78508b9ba2	2026-06-11	Warnings	Exact identifier unii: B697894SGQ

Reported adverse events (FAERS/openFDA)#

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